Restoring Trust in FDA: Rooting Out Illicit Products

Chairman James Comer (R-KY)SPEAKER_17

Okay, we're going to start. Good. All right. This hearing of the Committee on Oversight and Government Reform will come to order. I want to welcome everyone here today. Without objection, the chair may declare a recess at any time. I apologize for my laryngitis. We're going to try to fight our way through this, so I'll recognize myself for the purpose of making an opening statement. Again, welcome to the Committee on Oversight and Government Reform. Today, we will examine solutions to ensure the Food and Drug Administration keeps our nation's food and drug supply safe for all Americans. There might not be another federal agency that more profoundly impacts every American's daily life than the FDA. The FDA oversees the safety of the food, drugs, and medical devices we rely on. These responsibilities make it a key pillar of public health in the United States. But Americans are not getting healthier. Americans' life expectancy is four years less than other developed countries despite spending more than any other country on healthcare. Six in 10 Americans suffer from chronic disease. One in five Americans live with a mental illness. Nearly 20% of America's childrens are considered obese, 20% of Americans' children. So you would think the FDA under the Biden administration would have prioritized making Americans healthy, right? Wrong. President Biden's FDA pushed burdensome gender identity requirements on clinical trials that made compliance more expensive. They turned a blind eye to the Chinese Communist Party targeting our children by flooding our streets with illicit tobacco and nicotine products. They neglected infant formula facility inspections that led to mothers and fathers across the country being unable to buy the formula their children needed. And they failed to work hand-in-hand with the U.S. Customs and Border Protection to root out illicit pharmaceuticals, food, tobacco, and CBD. We are facing a national epidemic of chronic disease, mental health, and obesity, and the FDA under the previous administration sat on its hands. Thankfully, President Trump and Secretary Kennedy are taking action to make America healthy again. Soon after his return to office, President Trump signed an executive order removing unscientific pseudoscience compliance burdens for clinical trials. The FDA recently restarted approvals of safer alternatives to traditional tobacco products, and I'm hopeful more will come soon to bring greater clarity to the market. Secretary Kennedy announced Operation Stork Speed, which will provide families with access to safe infant formula for their babies and prevent shortages going forward. And President Trump's efforts to resecure the southern border have returned law enforcement's ability to stop the influx of illicit pharmaceuticals, food, tobacco, and CBD coming into our country. This committee has spent years investigating failures at FDA, and our findings are clear. The Biden administration stifled innovation with red tape and put bureaucrats before health of the nation. Reform is essential. The FDA must prioritize innovation, safety, and the health of all Americans. The FDA needs better systems to identify and address drug shortages. Quick approval of innovative medicines and techniques identified with AI in support of President Trump's promise to cure cancer is a necessity. The FDA must work with food producers to make our food healthier while not upending supply chains. Incentivizing domestic manufacturing of pharmaceuticals is essential to improving the safety of prescription drugs and will enable more research. Clearly and effectively regulating hemp products will reduce confusion and prevent intoxicants and poisonous contaminants from infiltrating the market. These examples are just scratching the surface of the dysfunction and failures within the FDA. Today, I'm hopeful we can take a deep dive to better understand how we can improve the FDA to make Americans healthier. I now yield to the ranking member for his opening statement.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

Thank you, Mr. Chair. Today's hearing comes at a critical moment for public health and safety. All Americans should be able to trust that our government is working to ensure their food and medicine will be safe and affordable. But over the past 2 months, the Trump administration has purged thousands of FDA workers, putting this essential mission and American lives at risk. Last week, the administration purged 10,000 people at HHS, including 3,500 FDA employees. This is on top of a purge of approximately 1,000 FDA workers in February. And Secretary Kennedy subsequently admitted that 20% of last week's purges should not have happened, tried to brush it off, saying, quote, "we'll make mistakes." But how long will it take them to realize the full extent of the mistakes that they've made? How long will it take for them to try and very possibly fail to undo them? And how many Americans will get sick or die in that time? The FDA is supposed to make sure that our children have the vaccines they need to survive outbreaks of preventable diseases like measles, which has killed at least 2 children in the U.S. since February and sickened more Americans in 2 months than the entirety of 2024. The FDA is supposed to protect us from counterfeit drugs and contaminated infant formula, which are serious bipartisan concerns. But how is the agency supposed to stop dangerous, illicit products from entering American homes and threatening American lives when underfunded food and drug inspection teams are are being cut even more? 170 employees from the FDA's Office of Inspections and Investigations were reportedly let go last week. Let me tell you some of the expertise we're losing because of the administration's actions. Besides that, they fired people responsible for regulating e-cigarettes and ensuring that predatory companies cannot market vapes to children. They fired people responsible for monitoring drugs for side effects and updating warning labels. They fired the scientists monitoring bird flu and taking steps to prevent it from killing people. They fired the scientists with expertise in fighting heavy metals, toxins, and additives in our food supply. And they fired the people who monitor prescription drug shortages and ensure that Americans have access to affordable prescription medications. How is this making Americans healthier? We all know the answer to that question. It's not. People are going to die. And as a dad, I'm especially concerned by the administration undoing the progress we've made to protect babies from contaminated infant formula and formula shortages. And we should all be concerned by the risk posed by contaminated meat and produce. This chaos will keep us in the dark about looming shortages for essential drugs like antibiotics and chemotherapy drugs, and it will leave people no choice but to pay for pricey, brand-name drugs because there are no FDA employees to approve generic versions. In the name of efficiency, this administration even fired employees who were critical in approving new medications, meaning Americans will have to wait longer for new treatments, if they get them at all. And on top of that, we just heard last night from the president that pharmaceutical tariffs will be next, making the drugs we all rely on even more expensive. One of the Americans impacted by these cuts is one of my constituents, a former teacher who spent 35 years working at the Department of Education. She has idiopathic pulmonary fibrosis, a terminal lung condition that took her aunt's life and is slowly taking hers. It's a rare disease that doesn't get much funding, but she had hope. A drug to slow down the disease received the FDA's breakthrough therapy designation in 2022, and the trials showed that it might actually stop the progression of her disease. Her doctor anticipated FDA approval this year, but the FDA's funding cuts and the firing of researchers and staff who sit on the approval committees have made this impossible. This administration is stripping both hope and lifesaving medications out of the hands of Americans who need it most. The FDA can and must do more for Americans. Addressing our country's chronic disease epidemic, ensuring our children are set up to live long and healthy lives, getting more lifesaving medications to those who need them, and ensuring that food on our shelves is safe and wholesome should be at the top of that list of things to do. But rather than making it better, more efficient, this FDA is left ransacked and reeling from the chaos and destruction of the Trump administration. It's unclear whether the agency can even perform some of its most basic functions anymore. I don't know how much clearer I can be. These health cuts will kill people. They will make us less safe and less healthy. I was not elected to watch people suffer from diseases awaiting new treatments while this administration dismantles the offices that offer that hope. It's the responsibility of this committee to conduct meaningful oversight. If we are not talking about this and doing something about these cuts, we're not doing our jobs. I yield back.

Chairman James Comer (R-KY)SPEAKER_17

The gentleman yields back. Without objection, Representative Moskowitz is waived onto the committee for the purpose of asking questions at today's hearing. I'm now pleased to introduce today's witnesses. Mr. Guy Bentley is the director of consumer freedom at the Reason Foundation, focusing on taxation and regulation of nicotine, tobacco, alcohol, and food. Mr. Jonathan Miller is the general counsel of the Hemp Roundtable and partner at Frost Brown Todd Attorneys. Jonathan is known for being a leading advocate for hemp and CBD legislation, has continually worked to promote policies that benefit the hemp industry. And just so my colleagues on the other side of the aisle know, my friend Jonathan Miller is a former chairman of the Kentucky Democrat Party. So, we try to be bipartisan in this committee, despite what you read in the paper, Mr. Miller. So, Mr. Richard Williams is a senior affiliated scholar at the Mercatus Center at George Mason University. He's an expert in cost-benefit analysis and risk analysis associated with food safety and nutrition. Mr. Shabbir Safdar is the executive director of the Partnership for Safe Medicines. He leads a coalition

SPEAKER_UNKNOWN

chain.

Chairman James Comer (R-KY)SPEAKER_17

And Mr. David Kessler is the former commissioner of the U.S. Food and Drug Administration under Presidents Bush and Clinton. Pursuant to Committee Rule 9(g), the witnesses will please stand and raise their right hand. Do you solemnly swear or affirm that the testimony you are about to give is the truth, the whole truth, and nothing but the truth, so help you God? Let the record show that the witnesses answered in the affirmative. Thank you all. You may take a seat. We appreciate you being here today and look forward to your testimony. Let me remind the witnesses that we have read your written statement. They will appear in full in the hearing record. Please limit your oral statements to 5 minutes. As a reminder, please press the button on the microphone in front of you so that it is on and the members can hear you. When you begin to speak, the light in front of you will turn green. After 4 minutes, the light will turn yellow. When the red light comes on, your 5 minutes have expired. We would ask that you please wrap it up. I now recognize Mr. Bentley for his opening statement.

Guy BentleySPEAKER_26

Chairman Comer, Ranking Member Subramanyam, and members of the committee, thank you so much for the opportunity to testify today. My name is Guy Bentley, and I'm the director of Consumer Freedom at the Reason Foundation, a nonprofit public policy think tank. The Consumer Freedom Project analyzes and promotes policy solutions that improve public health while avoiding unintended consequences and protecting consumer choice. I would like to focus on three points: first, the current state of the tobacco market; second, how we got here; and third, what can be done to reduce the illicit e-cigarette market while ensuring adult smokers have legal access to a range of safer alternatives. The focus of this hearing is rightly on rooting out illicit products, including illegal e-cigarettes, but there is some good news amid the disorder. Youth vaping has declined more than 70% since 2019 and is at its lowest level in 10 years. Youth smoking fell by 68% and is at its lowest level on record. These declines followed the decision to raise the age of purchase for tobacco products to 21, for which there was bipartisan support. Cigarettes remain the most widely used tobacco product, with 28 million adult smokers and more than 400,000 deaths per year attributable to smoking. There are also 18 million adult vapers who are using e-cigarettes to quit smoking. But thanks to the FDA's regulatory bottlenecks, since 2019, illicit products have flooded the market, with almost 90% of e-cigarettes being sold being sold illegally, mainly consisting of disposable products from China. Despite the huge demand for safer nicotine alternatives among adult smokers, the FDA has authorized just eight vaping devices for sale and 34 vaping products in total, and only in tobacco and menthol flavors, which have little appeal to most e-cigarette users. E-cigarette authorizations account for just 0.2% of all tobacco product authorizations, compared to 22% for combustible cigarettes. So how did we arrive at a situation where it is easier to release a new cigarette onto the market than the safer products invented to displace cigarettes, and the illicit products thrive? The answer is the FDA's approach to the premarket tobacco product application pathway, which is how e-cigarettes are evaluated and authorized for sale or not. The PMTA pathway, established as part of the Tobacco Control Act, was supposed to facilitate innovation for safer alternatives to cigarettes. In reality, it presents an almost insurmountable barrier. In 2022, an independent review of the FDA's performance as a tobacco regulator was published by the Reagan-Udall Foundation, which criticized the FDA's lack of transparency and timeliness in authorizing e-cigarettes into the legal market. It is unfortunate that in response to a report that emphasized the need for timeliness and transparency, the FDA issued a five-year plan of generalities with no substantive changes to the PMTA pathway. With a large illicit market now in place, the FDA has taken steps to ameliorate the problem with the creation of a multi-agency task force last year, increases in seizures, injunctions, and civil money penalties. But the only way to sustainably resolve the problem of the illicit e-cigarette market is to streamline the PMTA process to have regulated companies sell their company sell their e-cigarettes in the United States and reduce death and disease from smoking. Reforming the PMTA process would lessen current burdens on FDA staff reviewing e-cigarette applications, hasten the creation of a regulated marketplace, and restore public trust. The FDA insists its current approach to authorizing or denying e-cigarette products is guided by science and is appropriate for the protection of public health. But despite the best of intentions, a regulatory regime that results in a de facto ban of almost all e-cigarettes, incentivizing the illicit market, is not appropriate for the protection of public health. When it's easier to bring a cigarette onto the market than a vape or a nicotine pouch, both of which the FDA acknowledges are dramatically safer, that is not appropriate for the protection of public health. And an agency that fails to correct the misperceptions around e-cigarettes, with the majority of Americans now believing that e-cigarettes are just as or more dangerous than combustible cigarettes, that is not appropriate for the protection of public health. It is within FDA's current powers to change this dynamic and pursue a different path. Thank you, and I look forward to your questions.

Chairman James Comer (R-KY)SPEAKER_17

Thank you. Chair recognizes Mr. Miller.

Jonathan MillerSPEAKER_30

Mr. Chairman, Ranking Member, I'm grateful for the opportunity to testify before your committee today. Mr. Chairman, I'm especially grateful for your decades-long leadership on behalf of Kentucky hemp farmers. You and I started on this journey in 2012 and worked across the aisle to secure hemp's legalization in the Bluegrass State. Indeed, hemp's policy success has always been a bipartisan hallmark. And it's no wonder. Hemp products are made in the USA, harvested from crops grown by American farmers, manufactured by innovative U.S. entrepreneurs, and sold by small businesses dotting the nation. Unfortunately, the U.S. hemp industry continues to encounter avoidable bureaucratic headwinds in the marketplace, and this turmoil is due in large part to statements, actions, and indecisions of the FDA. When Congress passed the 2018 Farm Bill, it explicitly legalized the sale of hemp and its derivatives such as CBD. But just a few hours after the Farm Bill was signed into law, the FDA reasserted its opinion that it was illegal to market CBD as a dietary supplement. We've watched in bewilderment as FDA has jerked back and forth with contradictory opinions. First, the agency affirmed its ability to regulate CBD under current law, but then FDA stalled, even ignoring congressional appropriations report directives to take expedited action. Finally, in 2023, the agency stated that it cannot regulate CBD under existing regulatory pathways, essentially punting responsibility to Congress. This regulatory uncertainty resulted in a collapse of the CBD market, as demonstrated on this chart behind me, denying economic opportunity that was promised to farmers. The FDA's inaction doesn't just threaten CBD. A new industry focused on the adult market has emerged to meet consumer demand for hemp-derived cannabinoids like Delta-8 and Delta-9 THC. These products provide plant-based options for adults seeking functional health and wellness benefits. Furthermore, a promising new hemp beverage industry has soared into popularity, meeting adult consumer demand for nonalcoholic options through domestic inputs from our farmers. The only upward line on this chart represents the price of hemp flower, which recovered when it started being widely used for adult products, offering a lifeline to U.S. farmers. Unfortunately, lack of uniform quality control standards for hemp products at the federal level has forced responsible farmers and small business owners to compete against unscrupulous actors who generate headlines by distributing poorly manufactured products that are sometimes inappropriately marketed to children. A political backlash has ensued. Language was added into the 2024 House Farm Bill that purported to crack down on the bad actors. Unfortunately, the language went much farther. It would have federally banned 90 to 95% of the hemp product marketplace, including most non-intoxicating CBD products and animal feed, which offers great promise to farmers, while undermining a decade of progress for hemp fiber production. I want to be very clear: the hemp industry is united behind an appropriate response to these challenges—robust regulation of hemp products, not misguided prohibition. We support an approach that includes the following four the following 4 pillars: restrict youth access, increase quality control standards, standardized labeling, and standardized packaging. FDA could act today on applying this four-pillar approach to hemp products. We are hopeful that new leadership at the FDA will reverse the past course of inaction and take deliberate steps to robustly regulate hemp. This approach is precisely in line with the new administration's focus on providing adult consumers the freedom to make their own healthcare choices with holistic solutions that are grown on American farms. If laws must be changed, we urge Congress to act now. There are two viable pathways. First, we hope you'll consider Senator Ron Wyden's effort in the last Congress, S. 5243, that would ensure that the FDA regulates applying the four-pillar approach. A parallel effort could be to invest more authority in the states to properly regulate their own markets. In the absence of federal regulation, many states, like our Kentucky home, Mr. Chairman, have filled the policy void by developing new laws and regulations that balance market access with consumer safety. We urge you to implement a federal framework that authorizes the sale of hemp products and develops uniform standards for labeling, packaging, and testing while allowing states flexibility on more complex issues. In the meantime, we've taken the additional step of establishing the U.S. Hemp Authority, the industry's self-regulating organization, which sets rigorous standards for safety, quality, and transparency across the supply chain. The hemp industry may be unique in that we are coming to Congress to ask, please regulate us. Thank you for your consideration.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes Mr. Williams for his opening statement. Dr. Williams.

Richard WilliamsSPEAKER_08

Thank you, Mr. Chairman, Ranking Member, and members of the committee. Thank you for inviting me to testify about the FDA today. As I was nearing the end of my career at FDA, we were working on a rule governing how dietary supplements are made. After a year of looking, my staff could find virtually no benefits. When I suggested to the program office that maybe we shouldn't regulate, the response was, But Richard, we have to get these guys somewhere. So, we ended up with a regulation, not because it would make supplements any safer, but because we could start exercising control over that industry. With approaches like that, is it any wonder the FDA has lost the trust of the American people? During the course of my career, one of my employees asked me, Who do we work for? I thought about it. Well, there are FDA managers, the Health and Human Services Secretary, and the President. But then I made up a person. She's a 30-year-old widow with two kids working in a diner in the Midwest. That's who we're working for. We should only be concerned about getting results: safer food and helping people eat more nutritious diets. Again, when I look over my 27-year career, I was saddened by the fact that we hadn't made food any safer and American diets have gone horribly wrong. But we justified our regulations to say we would prevent hundreds of thousands of cases of foodborne disease and people would use the food labels to change their diets, preventing cancer, heart disease, and diabetes. None of that happened. FDA justifies budget increases with the same information every year, coupled with new challenges. But increased funding for FDA means more regulations, more control over the economy, and higher prices. I don't think people care about giving FDA more money or seeing them exercise greater control. They just want safe and healthy food. FDA never talks about the those actual outcomes, as they don't want to be held accountable for failures. In fact, they fight fiercely against any notion of accountability. FDA has to get the science right. For example, FDA ignores the biological science of evolution that shows us that tiny amounts of exposures to substances, natural and synthetic, are not harming us. In fact, when we're exposed to tiny amounts, well, well over half of all chemicals and all radiation, they not only don't harm us, they're actually beneficial. In addition, given the massive testing of food and color additives, it's unlikely that that's where the significant risks are. FDA needs to cut out ineffective programs and regulations, and going forward, needs to produce far fewer regulations. Ineffective programs include things like food standards. These are recipe standards from the 1930s that ensure manufacturers are producing foods just like Mother used to make. If we cut out useless programs and we have far fewer regulations, resources will be freed up to meet new challenges. For example, a better use of FDA resources would be to produce information that helps food producers, particularly the small ones. A good example would be letting producers know the root causes of foodborne outbreaks. The challenges are real. We need to know whether chemicals like PFAS and microplastics present health risk, and if so, which ones of the many varieties are actually risky. We also need to address food coming into this country with intentionally added poisons from some of the most powerful enemies we have ever faced. FDA must embrace new science and technology. To start with, FDA must be fully committed to precision health, including nutrition, as we're now beginning to understand that individuals respond differently to foods. That means that some national advice and even some regulations, while it may help some, will harm others. New technologies that will make food safer and healthier include smart packaging that will alert consumers to spoilage; blockchain-enabled tracebacks, which FDA has recently begun, I'm glad to say; robotics that can produce food more safely. There are new types of treatments for pathogens for manufacturers. Better foods can be produced through genetic modification and precision fermentation. And finally, for nutrition, there are new monitoring technologies that will give us real-time advice on what to eat based on our personal characteristics. FDA needs to make sure that the new technologies are safe, but also that we do not inhibit innovations that will save lives. To restore trust, FDA should be working for consumers like that mythical waitress who cares about results for her family. Thank you.

Chairman James Comer (R-KY)SPEAKER_17

Thank you. I now recognize Mr. Safdar for his opening statement. I apologize for mispronouncing that. Maybe you can correct my—

Shabbir Imber SafdarSPEAKER_31

It's fine. Chairman Comer, Ranking Member Subramanyam, distinguished members of the House Oversight and Government Reform Committee, thank you for your leadership on this issue and for inviting me today. My name is Shabbir Imber Safdar. I am the executive director of the Partnership for Safe Medicines, a coalition of all members of the supply chain dedicated to protecting Americans from counterfeit medicines. You've read my written testimony, and it's long, and I apologize for that. But it's very thorough. We've been doing this for over 20 years. But I want to just focus my comments on just three areas today which I think are of great concern, and they focus on the current crop of crime and patient endangerment around GLP-1s, or weight loss injectables. First, unlicensed vendors are selling unregulated GLP-1s to patients without prescriptions. We see these sold on e-commerce websites like Etsy, through med spas, which are unlicensed to often distribute prescription drugs, and also through fake online pharmacies selling them as peptides. They're often labeled as research chemicals like this one and not for human consumption, and yet people are being sold them with instructions to inject them anyway, and they often do. We're not the only group worried about this. In February, 38 states' attorneys general wrote to the FDA asking them to take action on these. And the FBI issued a similar alert, also raising concerns about compounders using illegal ingredients in their products and illegal compounding. Second, the FDA has cited patient safety issues even with legally compounded weight loss injectables. Now, compounded medicine fills a critical need in our drug supply and makes our drug supply more resilient. For example, consider a medicine that commercially comes in only an oral dosage form, like a pill, and the patient has swallowing issues, perhaps because they're a child or because their swallowing abilities are compromised. In that case, a compounding pharmacy can make a liquid form and allow that patient to take the treatment. That compounded treatment, while an unapproved drug by the FDA, is still better than skipping the treatment altogether. However, the FDA has been clear that these are not FDA-approved and pose safety risks because they are not clinically tested for safety or efficacy. But if a patient must choose between taking a needed medicine or skipping treatment, obviously you do take the medicine. But what we're seeing in compounding of GLP-1s is a different situation altogether. Opportunistic telehealth companies are enticing people who don't plan on using weight loss injectables to start therapy on these compounded unapproved products. And GLP-1s are sterile injectables. And compounding sterile products is very challenging, something we've actually seen from reading inspection reports by state boards of pharmacy and the FDA. On top of that, legitimate and safe ingredients for these medications are actually difficult to come by. And in every case I've seen in my experience, when things are difficult to come by, criminals step in to fill the gap. PSM recently studied freight shipments of both semaglutide and tirzepatide, the active ingredients in major weight loss injectables, coming in as freight using the FDA imports database. And most of these were coming in from China and India, in some cases Canada. And we found multiple entrant shipments that should have been denied entry at our ports. By studying that database, we found one shipment of semaglutide that claimed to be manufactured at a JW Marriott in Canada. Now, not surprisingly, we did check the FDA's registered facilities database for facilities in Canada. And that JW Marriott is not in fact an approved manufacturing site that's ever been inspected. It was refused by inspectors, which I am grateful for. But the second one was a shipment that was stated to be manufactured at a health club in Toronto, Canada. That shipment did actually make it through. And so it came in and we don't know where it went. I'm sure the FDA's Office of Criminal Investigation probably does. But it went somewhere in the US and is destined for US patients either by a legitimate or illegitimate dispenser. A third bucket of GLP-1s that I would like to point out are these lookalike counterfeits. It looks exactly like an injector pen that would come from the branded manufacturer, but it does not in fact contain the active ingredient or the right ingredient. Sometimes it even contains needles that have been compromised with bacteria. This is an example of a unit of fake Ozempic that is not in fact Ozempic. The criminals actually peeled off the label of the real product and then printed up an Ozempic label and put it on it. A very alert pharmacist in Arkansas spotted this unit and quarantined it so that it would not be given to a patient and called the investigator at the Board of Pharmacy. The Board of Pharmacy's investigator came over and used a new tool developed by the National Association of Boards of Pharmacy called Pulse. It's a scanner app. It's on your phone. And they used that tool to make a literally under-a-second determination that that product was counterfeit. That quick thinking by that pharmacist and that investigator almost certainly protected patients in Arkansas and around the country because the Arkansas State Board of Pharmacy then immediately moved to suspend the license of the Florida distributor who was shipping it into Arkansas so they could no longer do business in Arkansas. I am very proud of the safety of the U.S. prescription drug supply. It's the best in the world, and yet it contends with an enormous, perhaps globally record-breaking amount of criminality. And despite that, none of us have to worry about walking into a bricks-and-mortar pharmacy and getting a safe medicine. That is something that both keeps me up at night and actually also makes me very comfortable about living in the United States. I thank you for your time, and I look forward to your questions.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes Dr. Kessler. Make sure you've got the microphone pulled right up to you, so we can hear and C-SPAN can hear.

Dr. David KesslerSPEAKER_19

Mr. Chairman, Ranking Member, members of the committee, my name is Dr. David Kessler. I have worked for both Republican and Democratic presidents. I was appointed by President George H.W. Bush and reappointed by President Bill Clinton as commissioner of the FDA. We were responsible for accelerated approval, user fees, the food label, and the regulation of tobacco products. The FDA is a national resource. In January 2021, I had the privilege of returning to federal service and co-leading Operation Warp Speed. Mr. Chairman, I am in full agreement with you and share significant concerns about the safety and efficacy of illicit and sometimes licit drug products originating from overseas, particularly China. As you can see from the first graph, only 4% of active pharmaceutical ingredients—that's the key components of a drug—are produced in the United States. 80% are produced in China and India. In my opinion, for example, we have been conducting a reckless national experiment with compounded new weight loss drugs, the GLP-1s. Based on the information I've received from the FDA, it does not appear that there is routine FDA surveillance of the GLP-1s that are being imported into the United States from China for compounding to assure what is in the product. We cannot have confidence in the safety of compounded GLP-1 drugs. But that is only the tip of the iceberg. The conventional wisdom is that illicit cheap copies are coming from China. That has changed. The more significant threat, Mr. Chairman, is that China is attempting to surpass the United States in the sciences. As shown in the next figure, the highly respected Nature Global Index reveals that 8 of the top universities in terms of impactful research in the natural sciences are located in China. Specifically in chemistry, all 10 of the highest-ranked universities are in China. And only in the health sciences does the U.S. hold the lead. Do you want China to eat our lunch when it comes to science and innovation? We need to recognize that China is poised to surpass us in the sciences, and we need to quickly act to make the necessary investments to shore up our competitiveness and avoid putting our nation at risk. I know there are limitations in methodology. However, the U.S. scientists that I have spoken with increasingly see much higher quality work coming out of China. Look at the last figure. China is increasing investment in research and development, currently at approximately $500 billion as of last year. In contrast, our investment in the NIH increased only slightly from 2004 to 2016 and is now facing cuts. Whatever needs to be fixed, let's fix it, but we need to make a marked increase in our investment. I was a kid and went into the sciences after Russia launched Sputnik in 1957 as a result of our country's decision to be preeminent in the sciences. We are facing Sputnik 2.0 today, but with China. The current cuts to scientific research at the NIH and universities needs to be reversed. Otherwise, we are ceding the scientific primacy that Congress over the last 75 years has worked on a bipartisan basis so hard to ensure. One of the reasons we've been able to lead the world in health sciences is due to a strong FDA and its rigorous standards. One of my goals as commissioner was to ensure that if you needed access to a lifesaving drug and you lived in the United States, you would have access to it before anyone else in the world. We saw that with COVID-19, for example, with the monoclonal antibodies. Those drugs appear to have saved President Trump's life back in October 2020. Dr. Peter Stein's office made that drug available to the president and thousands of others. Dr. Peter Stein was removed from office in the recent rounds of cuts, as were thousands of others. It is no way to restore trust in FDA when you cut the person who may have saved the president's life. These cuts appear to me as devastating, haphazard, thoughtless, and chaotic. Mr. Chairman, I agree with your priorities of increased enforcement against illicit imports and counterfeits. I agree with your priority of improving the safety of our food. The current cuts will make achieving those priorities impossible. We need to be clear-eyed about the threat that China poses to American exceptionalism, especially in the sciences. We can't afford to be haphazard in our support of American scientific enterprise, not when China's commitment to the sciences is more real than it has been in the past. America's real competition in the sciences is China. The administration and Congress need to understand the nature of that competitive challenge and respond strategically, thoughtfully, and with appropriate strength. Thank you, Mr. Chairman.

Chairman James Comer (R-KY)SPEAKER_17

Thank you. And now we begin our questions. Chair recognizes Ms. Luna from Florida.

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

Thank you, Chairman. Good morning, everyone. I want to thank you all for being here today. But what we're dealing with isn't just about counterfeit vape pens or illicit Chinese imports. This is how the FDA, the agency that's supposed to protect the American people, has utterly failed to keep toxic chemicals out of baby formula, sunscreen, and food products being sold in stores here in America. Let me be crystal clear. American parents have every reason to distrust the FDA when Red 40, a known dye, is in their child's cereals, benzene is in sunscreen, also a known carcinogen, and Chinese-owned companies are allowed to dump trash on our shelves with Made in the USA slapped on it. The FDA has become a rubber stamp for big pharmaceuticals, big agriculture, and the CCP instead of looking out for the best interests of the American people. Mr. Safdar, is benzene, a known carcinogen, safe in any quantity in consumer products like sunscreen or face wash?

Shabbir Imber SafdarSPEAKER_31

Congresswoman, thank you for the question. PSM focuses mostly on prescription medications, and in fact entirely on prescription medications, and so I don't have the expertise to answer your question about sunscreen.

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

Okay, I appreciate your honesty there. For the American people watching, so you know, benzene is a known carcinogen and the FDA is allowing products with detectable levels of benzene to remain on the market. If they are genuinely fighting for the best interest of the American people, my question would be, why are they not saying anything about this? Mr. Safdar, would you also agree that the FDA can send armed agents into Amish dairy farms, but they are not keeping toxic Chinese-made face washes out of our stores?

Shabbir Imber SafdarSPEAKER_31

Congresswoman, thank you for the question. I, I neither work on anything related to food products or face washes, so I can't answer that.

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

Got it. Does anyone on the panel have an answer to that? No. Okay. For the— for just for context, here's an article that I'd like to enter into the record, Mr. Chairman.

Chairman James Comer (R-KY)SPEAKER_17

Okay. That objection is ordered.

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

The FDA was raiding Amish farms over raw milk, which, to be honest with you, is pretty absurd given that the FDA has dropped the ball on many other things that are actually causing causing cancer. Mr. Bentley, you talk about consumer freedom, but isn't it true that freedom-based— freedom is based on informed choices? And how can parents make informed choices when the FDA has allowed known neurotoxins like Red 40 in kids' food without warning labels?

Guy BentleySPEAKER_26

Congresswoman, thank you so much for the question. Food dyes is, I think—

Chairman James Comer (R-KY)SPEAKER_17

Make sure you got the microphone in front of your face so everybody— Yeah, there you go.

Guy BentleySPEAKER_26

I beg your pardon. Thank you so much, Congresswoman. I appreciate the question. I think the issue of red dyes is a particularly important one, and I think there does need to be further research into its relative safety. And to whether the FDA has taken a relaxed attitude or— and whether that these products, even if there isn't a known health risk at the moment, whether a precautionary approach should be taken into removing them from the market. So I think that's very up for discussion. And I hope new leadership at the FDA can look at these perhaps underexamined questions in more detail. And

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

Yeah, we'll be making those suggestions. As I'm sure you know, products based and manufactured in the UK, even in other parts of the world, are way different than American products. And just to put it in perspective, aside from corporate lobbying and regulatory capture, do you think that there's a reason why Red 40 would be still remain in American products when it's actively banned in the rest of the world? Just if you could, yes or no.

Guy BentleySPEAKER_26

No.

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

Okay I would say that because of the utter incompetence being displayed by the FDA, I understand that you are all not the head of the FDA, but I'm going to be choosing to reintroduce, and I'm glad that you backed me up on this one, the Do or Dye Act was what I introduced in the 119th Congress to remove some of those toxics, toxic chemicals and dyes from our food products. Dr. Williams, you're a former FDA economist. Can you please help me understand something? Why is the FDA moving faster to approve experimental drugs for billion-dollar pharmaceutical companies than it does to ban known toxins like benzene?

Richard WilliamsSPEAKER_08

Well, first of all, I worked in the First of all, I worked in the food section of FDA, not in the drug section, so I really can't comment on that. I will say

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

Just real quick, does anyone have a comment for that? Because we are at 41 seconds. Pharmaceutical? Nothing? Okay, sorry, continue.

Richard WilliamsSPEAKER_08

Okay, I will say that in terms of color additives, there's some misinformation out there. They're not banned in Europe. Actually, Europeans don't care that much about having color in their foods. The other thing is is that you really have to focus on the amount of exposure. Simply saying something is a toxin or a carcinogen doesn't mean a lot. What matters is what

Rep. Anna Paulina Luna (R-FL)SPEAKER_01

the exposure is. And I appreciate your position, but what I will tell you is if you have something that's known to cause autism with children, you have a young child's brain that's developing, I don't think that that's misinformation. I think that the American people are trusting the FDA to ensure that they don't even have to worry about the levels of additive that's has something that has a known detrimental effect on, on a child. Either which way, why are we adding fake stuff into product that should just be naturally made? I think that that would be the biggest argument. And I would say that big food wants it to be cheaper manufactured product because it's more of a net profit for them on the back end. Look, I'm already over time. I appreciate you guys being here today. But if you have anything that you can provide my office with, I would appreciate it because I think that the FDA needs an entire overhaul. And I think that the FDA currently is for sale. Thanks, guys.

Chairman James Comer (R-KY)SPEAKER_17

Chair recognizes Mr. Subramanyam.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

Thank you, Mr. Chair. Dr. Kessler, I was very interested in your testimony about how these cuts are affecting our food safety and really just our ability to have a functioning FDA. And so could you just tell me a little more? These firings at HHS and FDA in particular, we're trying to find effective strategies to bring new drugs to the market in a safe manner, but an expedient manner, but how do these cuts affect our ability to do that?

Dr. David KesslerSPEAKER_19

Imagine, Ranking Member, that you were this— you know, there was a major airline, and that major airline decided today that it was going to fire everyone except the copilots. It was going to run that airline and it only had the copilots. No pilots. The senior people are gone. People who fix the planes were gone. People who got people on the plane were gone. I think that's what we're facing with these cuts. Imagine If you try to run this Congress and there were only congressmen and congresswomen in the building,

SPEAKER_UNKNOWN

right?

Dr. David KesslerSPEAKER_19

That's what's going on at FDA today. I have major concerns. We are at risk. I think we are less safe today.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

I've talked to farmers who talked about the outbreak of avian flu. And we actually had the first mammal case of bird flu in the state of Virginia, the Commonwealth of Virginia, in my district on Monday. How would these cuts impact the FDA's ability to deal with the bird flu epidemic?

Dr. David KesslerSPEAKER_19

The leading experts on avian flu, certainly at FDA and at NIH—this is not just about FDA. Dr. Jeanne Marrazzo, who is running NIAID, taught me everything about avian flu. She is no longer there. We are at risk from infectious diseases. Look, I can't tell you whether we're one mutation away or two mutations away, right? It's had devastating effects. I mean, on our animal livestock. It gives me great concern. But that day is going to come. And those people that we need are not there.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

And I'd like to enter into the record a Washington Post article titled "Worries Grow Over Risks to Americans as Trump Cuts Health Safety Agencies."

Dr. David KesslerSPEAKER_19

Without objection, so ordered.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

April 6th. And so how would these firings at the FDA impact its ability to make sure that infant formula is safe and that we don't have another infant formula crisis?

Dr. David KesslerSPEAKER_19

Absolutely. You're exactly right. What we heard, I think, from my panelists, these are all complicated, whether it's hemp, whether it's e-cigarettes. These are complicated regulatory decisions. You have industries asking at this table, please, we need thoughtful regulations, right, that are well-balanced. Those people who are in charge of that policy at FDA to be able to work through to get to the right answers with the Congress, even to answer your requests for information, they're not there.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

And you said recently it's not too late to undo at least some of the damage that's been done. How much time do we have left before we can't fix what's been broken? And, and what would you do to fix it?

Dr. David KesslerSPEAKER_19

I always believed that things were fixable. Right. I mean, that was when I think we've seen that. Right. You can always go in and fix. The problem is, especially in the sciences, I've been the dean of 2 major medical schools. This is about expertise. This is about pipeline. If we lose a generation of young people,

SPEAKER_UNKNOWN

I

Dr. David KesslerSPEAKER_19

Young people got hit with COVID. I think we can't underestimate the effect. They couldn't go into the laboratories. They had to sacrifice their training. If we now have these cuts, right, at NIH, and a second time they can't get jobs as postdocs, we're going to lose a generation of scientists. They're going to set back this country, and that's true at FDA. We've lost 1,000 person-years of expertise in a few weeks. I don't think—if we let this go on for much longer, I think it's a matter of weeks, I don't think, you know this may not be fixable. This may affect us for decades.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

Thank you, Dr. Kessler. I yield back.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes the chairman of the General Operations Subcommittee, Mr. Sessions from Texas.

Rep. Pete Sessions (R-TX)SPEAKER_15

Mr. Chairman, thank you very much. Dr. Kessler, thank you for being here. We have had the former head of the FDA in before this committee several times. It was a purely political dance that he provided this committee, not only on answering the people that were not going to work, the empty parking lots at FDA, people who chose to work from home, not collaborating, working with each other for 4 years. This happened all across government, and I find it interesting that now the argument is everybody wants to come back to work when you and I know that we disagree on that issue. To the panel, I'd like to say to you, I had an opportunity this morning to look at WebMD, and you may have your own ideas about the effectiveness or how WebMD works, but the bottom line is that I'm looking at what might be delta-8, which is this unregulated form of hemp THC. It's called delta-8 THC. THC is an addictive product. WebMD says that marijuana, which is what THC is, use over several years causes brain effects like lower IQ, slower processing speed, memory, and attention issues. I would direct you to this slide here where delta-8 is involved, and it's marketed in such a way that it appeals to not only adults, but also to children. WebMD further says hemp's legality stems from the so-called federal farm bill, and I'm quoting this, the so-called farm bill which removed hemp and its byproducts from the list of controlled substances. The reason, hemp's low THC levels, less than 0.3, which was on the bill, but the bill doesn't mention delta-8 anywhere. And what's happened is chemists have come in and changed that viewpoint, not only of the hemp, which I was, as the chairman of the Rules Committee, very open to when the gentleman, the young congressman, former chairman, former head of the Agriculture Committee in Kentucky, came and asked me if I would allow this to be put into law, into the farm bill. And I went through a detailed explanation with him about what hemp stood for and how it might be used. I was told it was this: ropes, things that are used by Americans every day, but to build the market. And he did not say anything that was wrong to me. He said what was right at the time. But now these so-called loopholes, chemistry, these are dangerous products that create in not only my congressional district—the sheriff in McLennan County came to me and said, Congressman Sessions, please go to our hospitals and look and see what is happening as a result of delta-8, what's happening as a result of this hemp product that has become loaded with THC. I think what I would say to you is this: it is widely seen by many people as a dangerous product. It's dangerous not only to adults, it is very dangerous to children. Children who don't recognize the difference between what might be a small product, a gummy perhaps or something else, and then turns into an emergency episode at an emergency room. I think one of the telling things is comes from a guy whose name is Elton John, a well-known musician who has stated that of all the things that he's seen in his life, one of the worst things that he's seen is America and anybody else that legalizes marijuana. Marijuana is THC. And so, gentlemen, I will be watching you, and I am interested in the hemp industry, the same reason why, as chairman of the Rules Committee, I allowed it to be in the farm bill. But gentlemen, we've got to understand it is a dangerous product that causes IQ problems, it causes problems with slowness of adults, and it causes problems that are harmful to children. Mr. Chairman, I yield back my time.

Chairman James Comer (R-KY)SPEAKER_17

Thank you. Chair recognizes Mr. Krishnamoorthi from Illinois.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

Thank you, Mr. Chair. I want to show a visual here. Dr. Williams, according to the CDC, measles cases have skyrocketed during Donald Trump's time in office, with 607 confirmed cases and two tragic deaths. You don't dispute that, right? You've got to turn on your mic.

Richard WilliamsSPEAKER_08

Yep. Sorry. No, I don't dispute that.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

And, Dr. Williams, you wrote that, quote, "This tragic measles outbreak is a direct consequence of spreading misleading information about vaccines, and unfortunately Health Secretary Robert F. Kennedy, Jr. has played a role in perpetuating these false claims." You wrote that, correct?

Richard WilliamsSPEAKER_08

No, I did not write that. That must be another Williams.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

measles outbreak, RFK Jr.'s health agenda, and surprising health wins.

Richard WilliamsSPEAKER_08

No, sir, I did not write that.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

Okay, let me mention this. On Sunday, Mr. Kennedy finally said the most effective way to prevent the spread of measles is the MMR vaccine, but he did not disavow false claims that many people have said were directly linked to the measles outbreak. And this obviously is something that must be addressed immediately, correct?

Richard WilliamsSPEAKER_08

Yes, sir.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

Let me turn to my next topic. President Trump has put tariffs on just about everything, sending prices skyrocketing, and, unfortunately, the stock market is plummeting right now. Mr. Bentley, you wrote that, quote, "Tariffs of any kind are a direct tax on consumers," correct?

Guy BentleySPEAKER_26

That's correct.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

And Mr. Safdar, in a February 18th Q&A at the White House, the following was asked and answered of the president. He said the question was asked of the president, And what about pharmaceutical tariffs? Answer, It'll be 25% and higher. You don't dispute he said that, correct, Mr. Safdar?

Shabbir Imber SafdarSPEAKER_31

I was not at the White House, Congressman, but I'll take your word for it.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

Okay, thank you. Well, look, today, according to The New York Times and many other periodicals, even common medicines like Tylenol and the active pharmaceutical ingredients in Advil are primarily made outside the US and are now subject to tariffs. Moreover, according to Forbes and ING, researchers have found that tariffs will increase the price of all generics by about $42 per drug per year. So I come back to you, Mr. Bentley. You said tariffs in this article— tariffs aren't just a threat to the economy, they are a threat to public health. Correct?

Guy BentleySPEAKER_26

Correct, Congressman. I was talking about tariffs on e-cigarettes, which would be a threat to public health because e-cigarettes are a substitute for combustible cigarettes

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

And of course, tariffs on generic drugs would also be a threat to public health as well. Now, let me turn to you again, Mr. Bentley, regarding e-cigarettes. Mr. Bentley, by 2018 and '19, 20% of our kids were vaping, and the rate was doubling year over year, prompting Trump's then-FDA Commissioner Scott Gottlieb to call it an epidemic. However, at this time in 2018, you called the situation, quote, "an alleged epidemic," right?

Guy BentleySPEAKER_26

Correct.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

And today there are over 1.6 million youth vapers. Yet despite millions of underage users, you said recently that, quote, claims of widespread youth vaping are disputable. You said that in this article, correct?

Guy BentleySPEAKER_26

Correct. Because youth vaping has fallen dramatically since 2019.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

I assure you that the parents of the 1.6 million youth vapers don't believe that somehow claims of widespread youth vaping are somehow disputable. Now let me turn to your other article, another article that you wrote here. You said, quote, A Question of Taste: The Public Health Case for E-Cigarette Flavors. You believe, as the title suggests, that there is a public health case for flavored vapes, right?

Guy BentleySPEAKER_26

That's correct, Congressman.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

Let me just show you some of the American-built These are American-sourced vapes that are on the market currently. Strawberry Super Strudel. There's a public health case for that, right?

Guy BentleySPEAKER_26

There are 18 million adult vapers in the United States. There's

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

public health case for strawberry strudel?

Guy BentleySPEAKER_26

Yes, there is, because most—

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

And how about this one, Rainbow Road? There's a public health case for Rainbow Road, right?

Guy BentleySPEAKER_26

They all need to go through FDA review to be evaluated on their public health merits, which I completely support. But flavors are the overwhelming choice of adults, 18 million of whom—

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

13% of youth, according to you, 13% of youth, on page 3 of your statement, 13% of youth who vape cite the availability of flavors as their reason for vaping. So hundreds of thousands of children who have never smoked are taking up vaping because of these flavors. This is Sour Skittles. This is a Sour Skittle vape. Sir, your defense of flavored vapes is completely unacceptable and endangering our youth today. Thank you, and I yield back.

Chairman James Comer (R-KY)SPEAKER_17

Gentleman yields back. I'll recognize myself for questions. Mr. Bentley, tobacco is still a huge crop in my congressional district. Tobacco is still legal in the United States. The FDA collects $1.8 billion—actually, in 2014, the FDA collected $1.8 billion in user fees by the Center for Tobacco Products. Today that number's $3.5 billion in user fees. Despite this increase, FDA continues to put out unclear or incomplete guidance, causing the people in the business that want to play by the rules to have uncertainty. Why can't FDA properly regulate tobacco despite charging the tobacco companies billions of dollars?

Guy BentleySPEAKER_26

Thank you for the question, Congressman. And you're exactly right. The Center for Tobacco Products, run by FDA, has collected billions of dollars in user fees. And yet we have a nicotine market that is in chaos, with 90% of e-cigarettes being bought on the illicit market. What can change at FDA to resolve the problem of the illicit market is not more funding and staff, but the process of approvals.

Chairman James Comer (R-KY)SPEAKER_17

And just to touch on what my friend Mr. Krishnamoorthi said, it's my understanding that the FDA approved very few tobacco and nicotine products, even though many of the products in the PMTA process are safer than traditional cigarettes. Is that true?

Guy BentleySPEAKER_26

That's exactly true.

Chairman James Comer (R-KY)SPEAKER_17

So, why is the FDA refusing to authorize safer products?

Guy BentleySPEAKER_26

Because the FDA interprets what's called the appropriate for protection of public health standard in a particularly opaque and, we imagine, strict way. And that means fewer products by companies, as you say, Congressman, who want to play by the rules are getting to the market.

Chairman James Comer (R-KY)SPEAKER_17

And I would argue with what—to go along with what Mr. Krishnamoorthi said, the FDA's refusal to approve new tobacco products created a thriving market for illegal and unsafe products, the ones that Mr. Krishnamoorthi was talking about from China. These products are targeted at children. What should FDA be doing to prevent these illicit Chinese products targeting our children?

Guy BentleySPEAKER_26

FDA has set up a multiagency task force, particularly with partnership with DOJ and CBP, to try and track and halt the importation of products from China. But at the end of the day, this will be nothing really more than a bandage unless its own internal processes can be reformed, which also fortunately don't require more staff or more funding.

Chairman James Comer (R-KY)SPEAKER_17

All right, Mr. Miller, we're going to shift gears to talk about hemp and hemp derivatives. So the Congress legalized the sale of hemp, like Mr. Sessions was talking about, and hemp derivatives by removing them from from being Schedule I substances. To what extent has FDA regulated hemp-derived products like CBD?

Jonathan MillerSPEAKER_30

They haven't. And we as an industry are, are begging for that regulation.

Chairman James Comer (R-KY)SPEAKER_17

Why hasn't the FDA refused to regulate hemp and its derivatives despite having the authority to do so and despite the leading organization representing the credible manufacturers and producers of hemp begging them to do that?

Jonathan MillerSPEAKER_30

They've gone back and forth. They initially said that they were going to regulate products, and then they have now claimed they need to have congressional authorization to allow them to regulate that. We dispute that. And I do want to mention, because Congressman Sessions raised that issue about youth use of these products, we as an industry strongly oppose the sale of these products or the marketing of these products to children and really are looking for the FDA's help to make sure that that doesn't happen.

Chairman James Comer (R-KY)SPEAKER_17

How long would it take the FDA to do something like this? I mean, what are we talking here?

Jonathan MillerSPEAKER_30

Well, do

Chairman James Comer (R-KY)SPEAKER_17

We need a gazillion bureaucrats that work from home? Or what's involved in FDA regulating this, especially when you have the industry wanting to be regulated?

Jonathan MillerSPEAKER_30

So, there currently are a number of safeguards under current law that the FDA could use and has chosen not to use. Within the Federal Food, Drug, and Cosmetic Act, for example, the law precludes manufacturers and distributors from selling mislabeled or adulterated products, and it requires the manufacture and sale of products consistent with good manufacturing practices. The law also requires reporting of serious adverse events, and it mandates strict labeling, including, if FDA desires, warning against the use of products by children. Finally, the FDA, with the Consumer Product Safety Commission, could require childproof packaging. So, there's existing laws out there that they can take advantage of.

Chairman James Comer (R-KY)SPEAKER_17

All right, very good. My last question, Dr. Williams. We investigated the infant formula crisis extensively in this committee last Congress. Can you talk through quickly how the FDA failed to prevent the crisis and what needs to be done to improve competition and resilience to ensure an infant formula crisis never happens again?

Richard WilliamsSPEAKER_08

Yes. One of the main problems, particularly with supply, was that we would have manufacturers write to FDA and say, we're thinking about getting into the infant formula business. FDA would respond with, please don't. They wanted to keep the number of suppliers down to six, and they did that. So, consequently, when we had one plant that had a problem that actually had been investigated, when it had stopped production, that's when we hit a huge supply problem. But there was one other problem, and this stems from the Infant Formula Act dating back, I believe, to the '80s, where FDA produced a regulation that was addressing manufacturing of infant formula, good manufacturing practices. None of it, in my estimation and my analysis, would help infant formula at all. Nevertheless, the FDA was determined to go forward. The problem with that was, when FDA passes regulations on infant formula that raises the price of infant formula, for people who can't get it for free, what happens is less well-off consumers extend the infant formula with water. And there's nothing more dangerous than the primary source of nutrition being extended with water for infants. So, that's another problem that I think FDA needs to be aware of.

Chairman James Comer (R-KY)SPEAKER_17

Very good. Chair recognizes Ro Khanna from California.

Rep. Ro Khanna (D-CA)SPEAKER_20

Thank you, Mr. Chairman. Dr. Kessler, there's a dangerous anti-intellectualism that has become fashionable in our country today: attack the scientist, attack the thinker, attack the academic. Vice President Vance says the universities are the enemy. He's calling an enemy the president the university where the president who appointed you went, Yale, calling Harvard, where you were educated, the enemy, calling the very university he or I studied at the enemy. And I'm tired of politicians having this kind of false populism where they're attacking people who read, attacking people who think, attacking people who actually engage in intellectual excellence. What has been the alternative? Appointing people who didn't do the homework, who never read a book about economics or health sciences? We see what that's turning out to be. And I want to ask you, Dr. Kessler, because I was so concerned about the firing of Dr. Peter Marks, who has more qualifications than the entire Cabinet put together, who actually did the one thing with Operation Warp Speed that was Donald Trump's contribution. Can you talk about how offensive it is that people far less qualified, far less knowledgeable fired this man?

Dr. David KesslerSPEAKER_19

I don't think I could say it better, Congressman, than you just said

Rep. Ro Khanna (D-CA)SPEAKER_20

it. I mean, go ahead.

Dr. David KesslerSPEAKER_19

In fact, this feels a little surreal just sitting here, because everybody wants a stronger FDA. Everybody wants more regulation. Fix this. Make sure that infant formula is safe. Make sure that that drug is safe. Make sure that dietary supplement is safe. Do a better job. Go here. Go there. Make sure this import, right, doesn't contain any harmful products. I mean, but over the last several weeks, it— this agency has been devastated.

Rep. Ro Khanna (D-CA)SPEAKER_20

And, Dr. Kessler, I'm talking about something even deeper, because I agree with you, these cuts are going to hurt people. The life-saving treatments aren't going to get approved. But I understand people are angry in this country. They're angry that jobs have gone offshore, they're angry that wages have stagnated, but what you have is politicians exploiting it in a false populism to blame anyone who thinks, to blame anyone who reads, to blame anyone who has ideas. They're attacking the smartest people in our country and blaming them for problems that were caused by political failures. And we need politicians in this country who are going to say, We're going to stand to defend intellectuals. We're not going to be afraid of that. We're going to stand to defend institutions that have led thought. Lincoln called it mob rule. It's a story that goes all the way back to the to the Athenian mobs taking on Socrates. And I want people in our country, politicians, to stop with the false populism, to stop attacking the people who do their homework and who are leading inventions and who are leading science and leading thinking. Would President George Herbert Walker Bush, who actually sacrificed and fought in World War II, what would he have thought about this vice president attacking Yale, about this health secretary firing people of competence and exceptional talent?

Dr. David KesslerSPEAKER_19

I was there sitting at graduation as a dean when President Bush came to give the commencement address. These universities have contributed mightily to the, not only the intellectual life, not only to our freedoms, but to our competitiveness. And scientific advances have been generated by these universities. That was what this country, this Congress back in the '50s and '60s, set up this system. Vannevar Bush had a system that gave rise to the medicines that we have available today. We have to be able to support that biomedical infrastructure that is under attack. It needs to stop.

Rep. Ro Khanna (D-CA)SPEAKER_20

I appreciate your service.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes Mr. Grothman from Wisconsin.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Thank you. Got to respond to a little bit of that. First of all, wages are stagnating. They're stagnating under the law of supply and demand. We just had a president who let 10 million people in this country. Of course wages are stagnating. And I think a lot of times the business community is just fine with that. I've had businessmen complain to me: I have to give my workers another raise here. Isn't that horrible? Can we have more immigrants around here? So we know why wages are stagnating. They're stagnating because of excessive immigration. As far as our universities, there's no diversity of thought there. My one other comment, you talk about people who think and read. In my experience, people who are skeptical of our medical community or pharmaceutical community are the most well-read people in my district. That's why they're skeptical. They go beyond just the blather you get in the mainstream media. But okay, now we got to ask some questions here.

SPEAKER_UNKNOWN

uh,

Rep. Glenn Grothman (R-WI)SPEAKER_14

I'll ask one of you folks. It seems to me that we—am I correct here? We have more pharmaceuticals per person prescribed, consumed, or whatever in this country in the world, or at least more than any other Western countries? You don't know. Okay, we'll try to give you another question. Do we have more antidepressants consumed in this country than other countries? We don't know. Stumped again. Okay. Okay, we'll go for Mr. Williams. Americans have been grappling with—I'll digress for a second. As far as bringing new pharmaceuticals on the market, do you believe the pharmaceutical industry itself has a disproportionate influence in determining which drugs come on the market and which off-brand drugs are not going to be researched?

Richard WilliamsSPEAKER_08

My expertise is in food, food safety and nutrition, not in pharmaceuticals, unfortunately.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Okay. Well, we'll give you a food question then. Americans have been grappling with high inflation, especially food inflation during the Biden administration. Grocery prices rose 22%. Would you simplify the FDA's food regulatory structure to lower prices? Could you give me some examples of what could be done?

Richard WilliamsSPEAKER_08

Yeah, I believe that is exactly what I would do. I think a lot of the problem with FDA's food regulations from my expertise, and it really is now going on over 40 years and I continue to look at it, is that too many of FDA's regulations were not being made because it was going to keep food safer or because it was going to help nutrition. A lot of it is because of some firms controlling FDA saying we want regulations to put our competitors at a disadvantage. All those regulations have to be complied with, and all of that compliance by those firms raises prices. They don't pay for the regulations. This is a big misunderstanding, particularly in FDA. It's consumers.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Give me a ballpark number on which you think food prices could have dropped if we didn't have what I'll refer to as unnecessary regulation.

Richard WilliamsSPEAKER_08

I wish I had that information. I don't. But I think it would certainly help, and it would certainly help FDA to focus their resources, to target their inspections and focus their resources on real risk.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Okay We'll give Mr. Bentley a question or Mr. Miller. America does spend a great deal on medicine, and a lot of that is on drugs. Nevertheless, our life expectancy seems to be less than other developed countries. Can you comment on that?

Guy BentleySPEAKER_26

Congressman, my expertise is mostly in tobacco policy, but I will say an easy way that we could increase life expectancy and reduce cancer is have more authorized, safer alternatives to cigarettes onto the market, which FDA has been stymieing for the last 5 years.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Okay. Mr. Miller, you got any comments?

Jonathan MillerSPEAKER_30

I would just add that when it comes to holistic products, products made from American agriculture like hemp, these give alternatives to pharmaceuticals that a lot of Americans find tremendous relief in, and we should be promoting them. But we should also, as I've been saying, regulate them strictly.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Okay. I'll give Mr. Bentley and Williams and Mr.— fourth one down the line one more question or one more crack at it. It seems to me, compared to other countries, that we are overmedicated. And I'm not sure that it's resulting in better health. Could you comment on that?

Shabbir Imber SafdarSPEAKER_31

Congressman, my expertise is not in that area, but I will say that our drug supply, which is my expertise, is probably the safest in the world. In fact, the next time you go up and pick up a prescription, you probably should buy a $2 lottery ticket. You're more likely to hit that than to ever get a counterfeit medicine. In a pharmacy. It's, it's really the pride of the world.

Rep. Glenn Grothman (R-WI)SPEAKER_14

Thank you.

Richard WilliamsSPEAKER_08

I'll just add to that. In fact, I think medicine has been responsible for our longevity up till now, but I think it's time to focus on prevention. And I'm very glad to see that there are a number of people entering government now that are focused on prevention more than medicalizing people who are already ill.

Chairman James Comer (R-KY)SPEAKER_17

Okay. Before I recognize Mr. Mfume, Mr. Krishnamoorthi has asked for recognition of unanimous consent.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

Yes, Mr. Chairman, thank you so much for allowing me to enter into the record by or request unanimous consent for this article by our witness, Mr. Richard Williams, entitled "Measles Outbreak: RFK Jr.'s Health Agenda and Surprising Health Wins" from his website. And I'd give the witness a chance to remember that he wrote this, but it's from your website, this is your picture, this is your article, and this is your quote that I had from earlier.

Chairman James Comer (R-KY)SPEAKER_17

With that objection so ordered,

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

would you give him a chance to respond?

Chairman James Comer (R-KY)SPEAKER_17

Or if, if he wants to respond, it's up to the witness.

Richard WilliamsSPEAKER_08

I'll go back and take a look. But yeah, I don't recall that one.

Rep. Raja Krishnamoorthi (D-IL)SPEAKER_21

We'll give you a copy of this. Okay. It's serious to deny that you wrote this article.

SPEAKER_UNKNOWN

All

Chairman James Comer (R-KY)SPEAKER_17

Chair recognizes Mr. Mfume from Maryland.

Rep. Kweisi Mfume (D-MD)SPEAKER_05

Thank you very much, Mr. Chairman. My thanks to the witnesses who are here today. I want to just say a couple of things that are quite obvious and then turn the attention a bit to clinical trials. Dr. Kessler, I'm going to start by saying I'm going to end with you because I found your comments to be chilling and to be a real warning to where we are and where we are headed if we do not heed the fact that we are making big mistakes right now, every day, as we dismantle the Food and Drug Administration. But before I do that, let me just state the obvious, and that is that everyone, I think, wants to protect the health of all Americans. At least everybody should. And everybody wants to root out illicit products that always find their way into our markets. And that's why ensuring the health of the FDA is so vital to this country. It's got to have the resources to protect all of us, regardless of race, ethnicity, sex, or any other designation. It's critical to public health. Since the FDA Commissioner Markey was sworn—Makary was sworn into service on April 1st, Secretary Kennedy and he have pushed out and fired, as has been stated, over 4,000 federal employees at FDA. And just last week, more than 800 staff at FDA's Center for Drug Evaluation and Research were also fired. That center in particular is responsible for approving and monitoring new medications that come onto the market for side effects and for updating drug warning labels accordingly. Those fired workers, as has been stated earlier, are some of the nation's best and brightest scientists in charge of ensuring our supply of infant formula to make sure that it's safe, our medications for our family members and grandparents, food for all of us, and many, many ways the highest quality of food safety that we can expect in this country. So to have trust in the FDA, its decisions, and its ability to ensure effectiveness of the drugs that are approved, that requires research. It requires clinical trials. And those trials must include all American groups that may have need for the treatment. So effectiveness and safety cannot be ensured to all without the inclusion of all Americans in those clinical trials, which is why I'm particularly disturbed that these mass firings at our nation's health agencies, in addition to these anti-DEI efforts and similar rhetoric across this administration, will make improving the overall health of Americans much, much more difficult. So it was unfortunate to see that the FDA removed previously issued draft guidance on diversity in clinical trials from its website, as if to suggest that disease is racially monolithic. Clinical trials refute that. Clinical trials, when they are done correctly and with diverse participants, give us the ability over and over again to produce the best medications and to chart out the best courses. In this Congress, we passed several years ago something known as the Henrietta Lacks Enhancing Cancer Research Act in January of 2021. Many of you will remember this was initially led by the former chairman of this committee, the late Elijah Cummings. And this very committee listened to testimony about why it was important, and it was many of you on this committee that joined me and others on the floor to argue for its passage. And it was indeed passed. Mrs. Henrietta Lacks and her extraordinary story of her HeLa cells, which were alive many, many years after her physical death, have been very instructive in terms of finding a way to create cures for diseases. Jonas Salk will tell you that before he was able to finalize the polio vaccine, he had it tested against her cells long after her death to make sure that it was in fact effective. It's been effective in HPV vaccines, and it's been effective in helping the mapping of human genomes. So we don't want to go back to the days prior to Mrs. Lacks when no one wanted to talk about diversity in clinical trials, and we don't want to stay where we are, where we're erasing any allusion to diversity in those trials from the website of the FDA. I just don't understand it at all. I want to, if I might, just get your opinion, those of you who are here right now, as to whether or not you think that removing diversity from clinical trials helps the American public or advances medical science. Dr. Kessler.

Dr. David KesslerSPEAKER_19

It's absolutely essential that our clinical trials be done in a diverse population. There is great variability of biological response. I'm humbled when I look at medicines and how variable they respond in different people. It's just the nature of biology. We work very hard pharmaceutical industry, FDA, the universities to make sure that clinical trials are increasingly representative and diverse. If we want to understand how medicines work, we want safe and effective medicines. Clinical trials require a representative and diverse population.

Rep. Kweisi Mfume (D-MD)SPEAKER_05

Mr. Chairman, if I might have an additional 15 seconds, I'd like to ask unanimous consent that we enter into the record the GAO report to congressional committees 2 years ago entitled Cancer Clinical Trials.

Chairman James Comer (R-KY)SPEAKER_17

Without objection, so ordered.

Rep. Kweisi Mfume (D-MD)SPEAKER_05

I'd like to ask unanimous consent that we enter into the record Public Law 116-291, which many of the members of this committee voted in favor of, that created this whole notion of more diverse clinical trials, particularly in cancer research.

Chairman James Comer (R-KY)SPEAKER_17

Without objection.

Rep. Kweisi Mfume (D-MD)SPEAKER_05

And I'd like to ask unanimous consent to enter into the record clinical research entitled Genetic Variant and Cardiac Remodeling Injury and Heart Failure Risk in Black Adults.

Chairman James Comer (R-KY)SPEAKER_17

Without objection. So ordered.

Rep. Kweisi Mfume (D-MD)SPEAKER_05

Thank you. I yield back.

Chairman James Comer (R-KY)SPEAKER_17

Chair recognizes Mr. Perry from Pennsylvania.

Rep. Scott Perry (R-PA)SPEAKER_07

Thank you, Mr. Chairman. Gentlemen, thank you for being here. The average life expectancy for Americans is 78 years, despite spending more than every other Western developed country, which has a life expectancy of 82 years, so we're not doing so well. Six in 10 Americans have at least one chronic disease, with more than 40% of children, children suffering from at least one health condition. I just I think that's astounding. Mr. Safdar, as of March 31st of this year, the American Society of Health-System Pharmacists lists 238 drugs in shortages, in shortage. These shortages include pharmaceuticals used to treat infections, heart failure, psychiatric conditions, and cancer, and include drugs such as amoxicillin, penicillin, cisplatin, and active ingredients in most chemotherapeutic regimes. As you probably know, the medications taken by Americans are manufactured largely overseas, and their active ingredients are overwhelmingly made in India and China. Can you explain to us how our dependence on foreign pharmaceutical markets has created manufacturing delays for critical medications across the USA?

Shabbir Imber SafdarSPEAKER_31

Thank you, Congressman, for the question. While I am not an expert in the inspection of foreign facilities, it is clear that our supply chain is global at this moment, and medicines come and their ingredients come from all over the place. We are usually very pleased to see efforts to secure the supply chain and to secure manufacturing facilities with inspectors from the FDA, and it's part of what makes our supply chain most resilient.

Rep. Scott Perry (R-PA)SPEAKER_07

Do you think it's a good plan for the United States to rely so heavily on other countries, including ones that consider us their enemy, which would be the Communist Party of China?

Shabbir Imber SafdarSPEAKER_31

Well, the national security implications of that are definitely outside my expertise, but I think that the doctor here has probably got a better—

Rep. Scott Perry (R-PA)SPEAKER_07

Okay, Dr. Kessler, what do you got?

Dr. David KesslerSPEAKER_19

I'm very I agree with you 100%. I was in charge of, with my colleagues, Operation Warp Speed, of sourcing for the monoclonal antibodies, for example. We are at risk as a country. We are not producing in this country essential medicines for lifesaving conditions. We need to do a better job.

Rep. Scott Perry (R-PA)SPEAKER_07

To either one of you or anybody: is it because the precursors or the drugs themselves are rare and unattainable in the United States of America?

Dr. David KesslerSPEAKER_19

If you look at the top top universities for chemistry today, Nature Index, 10 out of 10 are in China.

Rep. Scott Perry (R-PA)SPEAKER_07

But, but is that because they're unavailable in the United States?

Dr. David KesslerSPEAKER_19

You need chemists make the drugs, right? Where are they training the chemists? Where is that scientific expertise? Right. We're not investing in this country in the natural sciences. So

Rep. Scott Perry (R-PA)SPEAKER_07

you're saying we have the material, we don't have the know-how. Is that what you're saying?

Dr. David KesslerSPEAKER_19

We don't have the know-how. We don't have the plants. We don't have the commitment.

Rep. Scott Perry (R-PA)SPEAKER_07

Do these drug shortages then enhance the proliferation of illegal knockoff drugs? Is that— is that a Is that a cause and effect relationship? We can't get them here. So there are knockoffs produced overseas, even in our country, that are often dangerous to people in our society that think they're taking a legitimate drug. They get it on the internet or get it over through the mail and then take it and then overdose. Is that, is that a part and parcel to this?

Dr. David KesslerSPEAKER_19

It is much— it's a much better strategy, right, to have the talent the expertise and the commitment and have those chemicals come from a secure supply chain, right, than through a lot of different unregulated sources. I mean, you want to lose sleep? That's what you should lose sleep about— where our medicines are coming from.

Rep. Scott Perry (R-PA)SPEAKER_07

Mr. Safdar, does the presence of a strong domestic compounding industry contribute to supply chain resilience and patient access at any time, but certainly during national emergencies or supply chain disruptions?

Shabbir Imber SafdarSPEAKER_31

Congressman, thank you for the question. Yes, as I said in my opening remarks, I think that there is a critical niche role that compounding plays in our drug supply. But as the FDA has said, compounded medications are not approved and they're not tested for safety or efficacy, so they should be used as a last resort. But as you pointed out, if there is a medicine you need for treatment that would be dangerous to your health to delay, you should definitely take the compounded version if the normal product, the FDA-approved product—

Rep. Scott Perry (R-PA)SPEAKER_07

you say seems to imply that they're somehow dangerous. Aren't they manufactured domestically in licensed facilities with oversight of state boards?

Shabbir Imber SafdarSPEAKER_31

The FDA has actually been very clear that their safety is not the same as FDA-approved drugs, which would be generics or the branded products, that they take a second tier to safety. They're They're not to be used as a first line of treatment. And that's one of the problems we're seeing, is that we're seeing upstart and unknown and somewhat shady telehealth

Rep. Scott Perry (R-PA)SPEAKER_07

companies. You're not conflating compounded drugs made in a facility, in a licensed facility under state monitoring or oversight, with illicit counterfeit drugs, are you? You're not conflating the two, are you?

Shabbir Imber SafdarSPEAKER_31

That's a whole— no, that's a whole nother problem. There is three types of danger that we've seen in the GLP-1 space. But even a medicine made in a state board of pharmacy or FDA-inspected 503B, for example, outsourcing facility is not an FDA-approved drug. The FDA has given it a status of being not approved and not tested for safety or efficacy. Now, would I take it if it was that or skip my cancer treatment? I would absolutely take it. But it's not supposed to be the first-line product. You don't start treatment on it.

Rep. Scott Perry (R-PA)SPEAKER_07

I

Chairman James Comer (R-KY)SPEAKER_17

understand. Thank you, Mr. Chairman. I yield. But before I recognize Ms. Brown, I have four UC requests: a letter from the Alliance for Pharmacy Compounding, a letter from the Council for Responsible Nutrition, a letter from the National Association of Convenience Stores, and a statement from Peter Pitts, the president of the Center for Medicine in the Public Interest. Without objection, so ordered into the record. Chair now recognizes Ms. Brown from Ohio.

Rep. Shontel Brown (D-OH)SPEAKER_03

Thank you, Mr. Chairman. The Food and Drug Administration exists to protect the public. It makes sure the foods we eat, the medicines we take, and the cosmetics we buy are safe and effective. Before any of these products reach store shelves, the FDA carefully reviews their development, testing, manufacturing, and labeling, and the agency keeps checking even after products are approved and available to make sure they remain safe and reliable. This work is vital. People need to trust that the FDA is making decisions based on science and facts. Unfortunately, from day one, the Trump administration has worked to undermine that trust. RFK pushes misinformation and lies. And just last week, President Trump recklessly fired thousands of workers across the FDA. These hardworking individuals, many of whom have been at the agency for decades and dedicated their lives to public service, were locked out of the building with no explanation. This isn't so-called government efficiency. It's playing petty politics with the health and well-being of the American people. These mass layoffs will delay reviews for new treatments and make it harder to ensure the safety of consumer products. Dr. Kessler, how will these staff cuts affect the agency's ability to oversee everyday consumer items like personal care products and cosmetics? And additionally, what is the typical review timeline for those products, and how might that change with less staff?

Dr. David KesslerSPEAKER_19

I think it endangers the safety of all Americans. I am told, for example, that no inspectors are cut, but what I hear is now the inspectors have to do all their administrative work themselves. Right. Their travel cards are restricted. Laboratories can't purchase the the supplies that they need, so they're they're not being used efficiently. They can't do their jobs. And this just makes no sense to me. I don't understand, right, what the strategy is. Why would you take the entire infrastructure of the FDA and blow it up?

Rep. Byron Donalds (R-FL)SPEAKER_00

There you go.

Rep. Shontel Brown (D-OH)SPEAKER_03

Thank you. The FDA plays a role in our everyday lives, right? Even if we don't see it. In 2023, after hearing troubling reports from around the country, Congresswoman Pressley and I asked the FDA to investigate the link between chemical hair straighteners, often used by women of color, and uterine cancer. Shortly after, the FDA proposed a ban on formaldehyde in those products. But when the agency missed the deadline to act, we followed up late last August because our communities deserve answers and action. Black women have long faced discrimination and scrutiny for how we wear our hair, pressuring many of us to turn to certain hair products just to meet societal expectations. But here's the truth: many of these products are poorly regulated and pose serious health risks. Studies have shown alarming results. Most recently, Consumer Reports revealed that several synthetic hair-braiding products used predominantly by Black women contain known carcinogens. This is not just about beauty, it's about public health. So let me be absolutely clear: these hair products we rely on every day are putting our health at risk. Today we sent another letter to the FDA urging them to move forward with the banning of formaldehyde in relaxers. With that being said, Dr. Kessler, given the historical underregulation of personal care products marketed towards Black women, what should the FDA be doing right now to ensure these products are thoroughly tested and safe? And during your time as FDA commissioner, did you encounter any barriers when it came to addressing equity and product safety?

Dr. David KesslerSPEAKER_19

Congresswoman, I just want to applaud you and your colleagues efforts. I think the issue you have raised is an enormously important one, and I applaud you for that.

Rep. Shontel Brown (D-OH)SPEAKER_03

Thank you. So I'm assuming there were some challenges there, and by your response, I'm grateful for your accolades, but I want to say this: We can't let the new administration drop the ball on something this important. So I plan to stay engaged and hold this administration accountable. Passing laws like the CROWN Act to prohibit hair-based discrimination is critical, but we also need to crack down on products that impact women's health and well-being. By requiring safety testing and making sure that public health research reflects the diversity of the market, we can help build a safer, healthier, and more trusted America. So with that, I want to say thank you, and I yield back the balance of my time.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes Mr. Biggs from Arizona.

Rep. Andy Biggs (R-AZ)SPEAKER_13

Thank you, Mr. Chairman, and thank you, witnesses, for being here today. As Congress looks to restore trust in the FDA and crack down on dangerous illicit products in our drug supply, it's critical that we distinguish between true public health threats and legitimate medical practices such as pharmaceutical compounding. Compounded medications, when prepared by licensed U.S. pharmacies and FDA-registered outsourcing facilities, are a vital part of our healthcare system. These drugs aren't counterfeit. They're not knockoff. They're not illicit. They're produced legally under rigorous oversight from state pharmacy boards and in many cases, the FDA itself. These are personalized medications crafted to meet unique patient needs or to fill gaps in the drug supply, such as when the FDA added semaglutide injection products Ozempic and Wegovy to its drug shortage list back in March and August of 2022, prompting compounding pharmacies to step in and fill the gap. Mr. Safdar told Mr. Perry that compounded drugs are manufactured domestically in licensed facilities under the oversight of state boards of pharmacy and the FDA. But some narratives conflate compounded medications with counterfeit or unsafe knockoff drugs. It's true that manufacturing standards are the same for compounded outsourcing facilities in the U.S. as those for branded pharmaceutical companies, and both adhere to the Good Manufacturing Practice system. Compounded drugs serve a critical role in maintaining access to care, particularly during times of FDA-approved drug shortages. There was a company in my district that was able to step up during the FDA shortage of semaglutide injection products. The presence of a strong domestic compounding industry contributes to supply chain resilience and patient access during national emergencies or supply chain disruptions. Mr. Safdar, your organization, the Partnership for Safe Medicines, from 2007 to 2017 was staffed or led by a guy named Scott LaGanga, is that right?

Shabbir Imber SafdarSPEAKER_31

I believe so, yes.

Rep. Andy Biggs (R-AZ)SPEAKER_13

Did you follow him?

Shabbir Imber SafdarSPEAKER_31

I was the— I'm the executive director that came after him.

Rep. Andy Biggs (R-AZ)SPEAKER_13

Yeah. So when you say, I believe so, what you really meant to say, Yes, of course I know that was Scott LaGanga, right? You meant to say you knew that he was the guy that was leading your organization before you were, right?

Shabbir Imber SafdarSPEAKER_31

I do not know the exact dates, but I know the end date was 2017 because that is when I started.

Rep. Andy Biggs (R-AZ)SPEAKER_13

So, so that's a, that's a real cutesy response. And the reality is, you know, he was your immediate predecessor.

Shabbir Imber SafdarSPEAKER_31

I do. He is, right?

Rep. Andy Biggs (R-AZ)SPEAKER_13

Right. And so I have a series of reports sitting right here. Before I go through with them, I just want to know, is your funding sources still the same as they were under him?

Shabbir Imber SafdarSPEAKER_31

We are funded by our members and dues from our members, which are listed on our website.

Rep. Andy Biggs (R-AZ)SPEAKER_13

Right. I've gone to your website. I've read them. Do you get— do you get money from large pharmaceutical companies?

Shabbir Imber SafdarSPEAKER_31

No, sir. We get money only from our members, and our members are only trade associations or not-for-profits. So if you're an actual company, a for-profit company, you cannot give us money. You cannot give us— provide us funding.

Rep. Andy Biggs (R-AZ)SPEAKER_13

All right, very good. I have here now, Mr. Chairman, this— this is following items here. Article called, "Nonprofit Linked to Pharma Lobby Works to Block Drug Imports," Nonprofit Linked to Pharma Rolls Out Campaign to Block Drug Imports. Without a— Go ahead. Nonprofit Linked to Campaign Against Drug Imports Has Deep Ties to Pharmaceutical Research and Manufacturers of America. And then, Mr. Chairman, I have now another one called, a new report reveals— it's it's a blow-by-blow takedown of a report by this organization. This is produced by the Alliance for Pharmacy Compounding, and it deals with a report issued by Mr. Safdar company called, "New Report Reveals Illegal Ingredients for Knockoff Weight Loss Drugs Flooding into U.S. from Foreign Sources, Endangering Patient Safety."

Chairman James Comer (R-KY)SPEAKER_17

Without objection, so ordered.

Rep. Andy Biggs (R-AZ)SPEAKER_13

Thank you. And then also, I have a letter from the Alliance for Pharmacy Compounding dated April 8th, 2025, that was sent, I believe, to you, Mr. Chairman.

Chairman James Comer (R-KY)SPEAKER_17

Without objection, so ordered.

Rep. Andy Biggs (R-AZ)SPEAKER_13

Thank you, Mr. Chairman. I do think that Um, attacks on compounding pharmacies by this particular organization when we're talking about whether something's a knockoff, illicit, or illegal or counterfeit drug is inapt and unfortunate. And Mr. Chairman, with that, I yield back the balance of my time.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes Ms. Stansbury from New Mexico.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

Thank you, Mr. Chairman. I just want to ask a quick question. This is the Oversight Committee, correct? That's right, we're in the Oversight Committee. So I have to say, I found this to be a very bizarre committee hearing because here we are in oversight, and our job is to conduct oversight over the administration because of the separation of powers between Congress and the executive branch. And right now, the administration is dismantling the Food and Drug Administration. And we are sitting here, and members on both sides of the aisle are asking questions of industry-funded groups about how the FDA is going to protect public health from medicines and food while the secretary is firing thousands of FDA employees. In fact, just this last week, they announced they were firing 3,500 members of FDA, and RFK Jr. announced that he was going to fire 10,000 HHS employees across the entire agency. So my question is, if this is the Oversight Committee, why are we not conducting oversight over the administration and their mass firings and the actual deconstruction of the exact agency that's supposed to protect the public health? That is what we should be doing right now in this hearing room. So I find it very bizarre that many of my friends across the aisle are asking how these folks are going to protect the public health, because they're not, because they're dismantling and taking out the top experts who do this work. Now, some of my colleagues have already pointed out that one of the top vaccinologists, not just in the United States, but in the world, Dr. Peter Marks, was forced to resign. And in a few moments, I'm going to enter his resignation letter into the record, because it's instructive. In his resignation, he says that for the last 13 years, he's tried to ensure the efficiency and effectiveness of the science and the public health. And he says at the end of his letter, However, it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies. I've been trying to figure out for the last couple of weeks what exactly the angle is inside of HHS, what exactly the angle is inside of FDA, what exactly the GOP's theory of MAHA, of Make America Healthy Again, is, because today, you want to take a vote on dismantling Medicaid. Your president is mass firing thousands of public health officials, including the people who make our drugs, our medications, our food, our cosmetics safety. Your president announced yesterday that he wants to put tariffs on pharmaceuticals, and you're going after Social Security and Medicaid by dismantling the offices and the services and programs through DOGE that actually serve the people of this country. So, I don't understand it. I don't understand how this serves the public interest. Dr. Kessler, I am very grateful that you are here today. You are a legend. You are so well known across the public health space. And I know you're not currently serving in this administration, but help us understand the scope and the scale, and why the American people need to be paying attention to what's happening inside the agency right now.

Dr. David KesslerSPEAKER_19

Twenty cents of every consumer dollar is spent on a product that FDA oversees. All our foods essentially, except meat and poultry, USDA does that. All our drugs, all cosmetics, our blood supply, our medical devices, many of our radiological devices. The agency is absolutely essential for the safety of the American family. It's also absolutely key for our competitiveness. I am concerned that China's going to beat us scientifically if we're not careful with all these cuts that are going on. But the reason I'm concerned about that, it's not about China; it's about the health of us.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

And Dr. Kessler, I just I want to end with this note. As Vera Rosenthal was leaving the department after being fired by the secretary, she said, People are going to die from these cuts. I am not being an alarmist. The day after they announced these mass firings and cuts, pharmaceutical prices tanked on the market, and that was before tariffs. And that's because the ability to get life-saving drugs to market, the ability to save American lives, the ability to get—

Rep. Marjorie Greene (R-GA)SPEAKER_12

gentlelady's time has expired.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

To our people.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Gentlelady's time has expired.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

On having a functioning—

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentlelady's time has expired. I now recognize Mr. Higgins from Louisiana.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

If they do not have the— The

Rep. Marjorie Greene (R-GA)SPEAKER_12

gentlelady's time has expired.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

The gentlelady's

Rep. Marjorie Greene (R-GA)SPEAKER_12

time has expired.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

The American people. The

Rep. Marjorie Greene (R-GA)SPEAKER_12

gentlelady's time has expired.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

Ms. Stansbury. Ms.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Stansbury, the gentlelady's time has expired. No, you're lying to the American people.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

I'm sorry, madam.

Rep. Marjorie Greene (R-GA)SPEAKER_12

You are lying to the American people.

Rep. Melanie Stansbury (D-NM)SPEAKER_23

The American people need to understand their health is at risk. And this is

Rep. Marjorie Greene (R-GA)SPEAKER_12

a fire alarm emergency. Mr. Higgins from Louisiana is now recognized.

Rep. Clay Higgins (R-LA)SPEAKER_16

It's always fascinating to witness the wailing and gnashing of teeth, is it not, gentlemen? Mr. Williams, I'm going to be talking to you mostly, sir, some questions and observations regarding FDA and food safety. Let's just talk about seafood for a second, please. About a year ago, we had a hearing where members interacted mostly—we're not overspoken by other members. The members interacted with with our witnesses, and it was it was confirmed broadly that only about 1/10 of 1% of seafood imported into our country was inspected for for chemical and biological poisons. And we're talking about billions and billions of pounds of seafood coming into our country. It's consumed by Americans or else why is it coming here? And the and the only reason you don't get immediately sick in many cases is because we cook it, and it it it kills some of the some of the potential biological hazards and things. But the the chemicals and the long-term impact on cancer, neurological disorders, and and serious problems can arise. You know, one might say a reasonable observer may say that if you're consuming billions of pounds of poisonous seafood imported into our country, somebody might get sick, speaking of health. So, we believe there's been progress made in this arena of protecting Americans from from the harmful biological and chemical elements that have been found broadly in imported seafood. Can you speak to how we're doing with that, Dr. Williams, in the past in the since this year, 2025?

Richard WilliamsSPEAKER_08

Yeah, I guess I could start briefly by just saying originally we had a rule on seafood called Hazard Analysis Critical Control Points, where we hoped that was going to make a big difference. Unfortunately, the problems with seafood, most of it is seafood consumed raw. And I'm thinking raw oysters from the Gulf of wherever. And that's a problem because there's not much in the way you can do about that. They're taken right from the Gulf, they're already contaminated by the warm waters of the Gulf, and when they go straight to people and eat them they are eating, in many cases, dangerous pathogens. There are— I think one of the problems that we have with imported seafood, again, it's the problem that we have with everything, is the resources that we devote to so many things at FDA that are not useful could be better used if we got rid of ineffective programs, if we got rid of regulations that don't work, so we could really focus, target our inspections, have more resources to target our inspections on those products.

Rep. Clay Higgins (R-LA)SPEAKER_16

Would you agree that there's, that there's a high level of responsibility for the nations of origin, uh, to do proper inspections and their, and their, their procedures for farming and harvesting and packaging and, and shipping are in no way do they meet American standards that American producers are required to comply with. And yet there's— they're in violation of agreements that they will perform at standards equivalent to American standards. Don't you believe we should enforce that?

Richard WilliamsSPEAKER_08

Yeah, I think one of the problems is where are they actually coming from? So, for example, I mean, I can give you an example in furniture.

Rep. Clay Higgins (R-LA)SPEAKER_16

We've identified many, many nations and they bounce their product around. So

Richard WilliamsSPEAKER_08

exactly, yes,

Rep. Clay Higgins (R-LA)SPEAKER_16

sir. The question is, and because I'm running out of time here, are we making progress regarding controlling poisoned seafood coming into our country?

Richard WilliamsSPEAKER_08

I really can't speak to whether or not we're actually making progress, but I want to agree with you. For example, if seafood says it's coming from Vietnam, for example, where I was, it may actually be coming from China. That's one of the things they do. They send their products through Vietnam to us. So I think it does make it difficult for our inspectors.

Rep. Clay Higgins (R-LA)SPEAKER_16

And this administration, the Trump administration, has been quite aggressive, and I'm thankful to that, to protect Americans from harmful seafood coming into our country. The FDA's control over other poisons that find their way into our food supply, the colored foods, etc., can you just speak to that? I'll allow you to answer if the chairwoman will allow. And that's the balance of my

Richard WilliamsSPEAKER_08

I don't, I don't quite understand your question. Can you repeat

Rep. Clay Higgins (R-LA)SPEAKER_16

the way the FDA will address poisons in our food to add, say, brightness of color to children's cereal, etc.?

Richard WilliamsSPEAKER_08

Yeah, the color additives, these are tested, particularly for carcinogens, every single one of them before they come on the market. There still may be things that they didn't test for that might cause a problem, but they're some of the most tested substances on Earth. So I think there are other issues that we should be concerned about.

Chairman James Comer (R-KY)SPEAKER_17

Chair now recognizes Mr. Garcia from California.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

Thank you, Mr. Chairman. I want to first begin by thanking all of our witnesses for being here and for your testimony, obviously for for all the comments that we've we've heard here from from both sides of the aisle in the committee. I do think that it's ironic that we're holding a hearing on restoring the trust in the FDA while we're ignoring the single biggest threat to public health today, which is, of course, is Donald Trump's Health Secretary, Robert F. Kennedy Jr. Now, together with Elon Musk, RFK Jr. is actively undermining the institutions that protect public health and the safety of all Americans. Now, we know that RFK Jr. already has a history of outrageous medical opinions and a dangerous anti-vax record. Now, let's just look at the measles alone. Before the measles vaccine, we know that measles would kill 400 to 500 American children annually. Now, after, of course, that vaccine was released, that number fell to almost nothing. But now, with RFK's anti-vax movement growing and his dysfunction at HHS, we've seen over 600 confirmed measles cases across 22 jurisdictions. And that, of course, is not a coincidence. We also know that this is also just the beginning. This committee is not serious about actually taking on the public health threat of measles, which, by the way, our measles cases today is 50 times higher than we have trans athletes in college sports. Yet they obsess about that every single day. The committee is obsessed with things that don't matter, but not the public health of actual Americans and children. By the way, children are now actually dying. And we know that, of course, that's just the beginning. RFK Jr. has said that 5G and Wi-Fi can cause brain damage, ADHD, radiation sickness. He's said that pesticides are actually turning people transgender. He's even questioned whether HIV causes AIDS. He's made comments, of course, that alkyl nitrite, better known as poppers to some, is the actual cause of AIDS. He said during a campaign event that 100% of the people who died, the first 1,000 who had AIDS, were people who were addicted to poppers. In his 2021 book and 2023 interview with The New York Times and New York Magazine, he repeated claims that question the causes of AIDS despite overwhelming evidence to the contrary. In my opinion, RFK Jr. has been and will always be a tinfoil-hat conspiracy theorist. He should be nowhere near, anywhere near HHS, medical opinion, and our research in this country. Now, Dr. Kessler, I hate to have to even ask you this, but is there any serious medical evidence that HIV does not cause AIDS?

Dr. David KesslerSPEAKER_19

No.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

Thank you. And that's exactly why these cuts by DOGE and RFK Jr. to HIV research, treatment, prevention are so dangerous. Public health experts warn that these actions will set us back decades. Now, despite Donald Trump's 2019 State of the Union promise to end the HIV epidemic, we've seen over $800 million in HIV research actually cut. HHS, the Office of Infectious Disease and HIV Policy has been shuttered. CDC surveillance efforts have been gutted. PEPFAR, the Global Fund, all, of course, lifesaving initiatives are being dismantled. Now, Dr. Kessler, now, you led the effort to fast-track approval for lifesaving AIDS programs. Can you just briefly in a sentence or two explain how DOGE is going after the work?

Dr. David KesslerSPEAKER_19

I also chaired the board of the Elizabeth Glaser Pediatric AIDS Foundation,

SPEAKER_UNKNOWN

you

Dr. David KesslerSPEAKER_19

with President Bush, the son,

SPEAKER_UNKNOWN

right?

Dr. David KesslerSPEAKER_19

That was— I mean, the goal was to stop mother-to-child transmission throughout the world of HIV. It was the moral conscience of this nation,

SPEAKER_UNKNOWN

right?

Dr. David KesslerSPEAKER_19

Global health relies on America, and that has been drastically cut.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

That's absolutely right, sir. And we also know that RFK Jr., while this is happening globally and here back home, he's fired 10,000 people from his agency and then claimed that 2,000 of those was actually a mistake. So firing people, claiming they're a mistake, gutting the agency, taking away support from life-saving programs, spreading anti-vaccine conspiracy theories, that's what RFK Jr. right now is all about. And these aren't just mistakes; they're life-or-death decisions. Critical staff have been lost. Experts overseeing medicines, food safety, and medical devices, as we know, have been have been shut or let go. And we're incredibly concerned. I want to read this quote by former FDA Commissioner Robert Califf. Quote, "The FDA, as we've known, is finished with most of the leaders, institutional knowledge, and a deep understanding of product development and safety no longer being employed." It is totally unacceptable that Congress is doing nothing to prevent, of course, this absolute destruction of our public health infrastructure. We need to stop this now. And with that, I yield back.

Chairman James Comer (R-KY)SPEAKER_17

gentleman yield back. I just have to comment, Mr. Garcia, in all good faith, the predecessor for the ranking member, Mr. Raskin, said that those of us who wondered if COVID came from the lab at Wuhan, we were conspiracy theorists. And when we started suggesting that maybe former President Biden was in mental decline, that we were conspiracy theorists. And now, you know, there's just books coming out by all these Democrat journalists every day saying what we had wondered, too. I'm not defending or trashing what you said about Robert F. Kennedy. It's just that conspiracy theories are in the eyes of the beholder.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

Sir, sir, do you think that, that children should be getting the measles vaccine?

Chairman James Comer (R-KY)SPEAKER_17

That children

Ranking Member Robert Garcia (D-CA)SPEAKER_25

should be receiving the measles vaccine?

Chairman James Comer (R-KY)SPEAKER_17

I have— all my children are vaccinated.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

And do you think that we should be getting vaccinated for COVID?

Chairman James Comer (R-KY)SPEAKER_17

Well, I don't. I think there's a lot of questions about COVID that we need answered. But, but measles, yes.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

And

Chairman James Comer (R-KY)SPEAKER_17

I recognize this.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

And again, and again, the— our current HHS secretary is an anti-vax conspiracy theorist. And that is— that is a fact. He caused a measles outbreak in another country that caused the death. Absolutely. That caused—

Rep. Marjorie Greene (R-GA)SPEAKER_12

No, he did not.

Ranking Member Robert Garcia (D-CA)SPEAKER_25

He absolutely did. That's a lie. Proven.

Rep. Marjorie Greene (R-GA)SPEAKER_12

RFK did not cause a measles outbreak. Ms. Greene, you

Ranking Member Robert Garcia (D-CA)SPEAKER_25

are an

Rep. Marjorie Greene (R-GA)SPEAKER_12

anti-vax. You are ignorant. And that's a lie. No, I'm for choice. I'm for parents and people choosing. That

Chairman James Comer (R-KY)SPEAKER_17

was my fault.

Rep. William Timmons (R-SC)SPEAKER_27

Mr. Chairman, am I recognized? Am I recognized?

Chairman James Comer (R-KY)SPEAKER_17

Our witnesses were snoozing, so I had to spice it up a little bit. Wake up. Chair recognizes Mr. Timmons from South Carolina.

Rep. William Timmons (R-SC)SPEAKER_27

Thank you, Mr. Chairman. So I realize that we're here to have a hearing about restoring trust in the FDA, rooting out illicit products, but I'm actually going to turn it upside down, and I'm going to talk about how the FDA is not approving products that will help Americans. And so I guess normally it's good to be leaders in the world, but not when it comes to obesity, not when it comes to chronic disease management, not when it comes to diabetes. And these are all things that I believe technology has the ability to help ameliorate and really facilitate better outcomes. And so what I want to talk, Dr. Williams, is about continuous glucose monitors. I have used them. I was in a test trial, and it was one of the most enlightening experiences. It attached to my cell phone. I am not a diabetic, but the information I got from that piece of technology changed my life. It did. It changed my life. And the FDA has not approved use of a continuous glucose monitor without a prescription—well, they just did, but you have to have type 2 diabetes who are not on insulin. Dr. Williams, do you believe that any American that wants to use a CGM to understand what the food that is putting in—that they're putting into their body does to their to their blood glucose levels, do you think that's something that should be available to the general public?

Richard WilliamsSPEAKER_08

I do. I don't see any harm. If they want that.

Rep. William Timmons (R-SC)SPEAKER_27

These have been around for a very long time, and the technology is used by millions of Americans, unfortunately, because they need it. They have diabetes of some kind. And I don't understand why it has taken them this long. And it's interesting because a lot of companies are using CGMs. They're marketing them. They're selling them to Americans, and it's technically illegal because they were not approved. They were approved, I guess, in March of last year, but why is the FDA not approving the use of technology that will help improve Americans' lives?

Richard WilliamsSPEAKER_08

I think part of the issue lies in medical device laws, and they are really antiquated. And I researched this years ago. The problem is when you go to invent something, you have to get it approved. It costs a lot of money and a lot of time to get approved. So a lot of inventions that actually would come from physicians, they don't do it because they look at the time and the expense and having to raise money, and they don't want to do it. The second problem is, once you get it approved, if you think about how inventions work, think of computers. You make a computer, you find bugs in it, and then you change it. And you change it repeatedly. Medical device laws do not allow for that. Every single change you make, you have to go back to the FDA. And so that is one of the reasons I think we're not seeing the innovation that we should, particularly on these kind of monitoring devices. The ones you're talking about are just the beginning. We need to monitor what we eat, how much we eat. We need to know everything about our biomarkers, our genes, our epigenetics, and everything. Put all that together and give people real-time advice on what to eat. It's doable.

Rep. William Timmons (R-SC)SPEAKER_27

Well, and hold them accountable when they don't eat eat well, when they when they treat their body poorly. So, I mean, diet and exercise is the answer to 95, 99% of health problems, and we have a pill for everything. We have a shot for this, shot for that, pill for this, pill for that. And I think that we can use technology to create an incentive structure, and possibly a disincentive structure, to facilitate decisions. If you take the technology in an Oura Ring and a Fitbit and a CGM and you put it all together and you have one device that's monitoring all of that, I think that you should— I think it could then communicate with your health insurance company and you'll get a benefit in your premium if you are not spiking your blood glucose level and if you're exercising every week. This technology exists. It just needs to be put into one, and the incentive structures and disincentive structures need to be placed on the free market. I mean, does that make sense?

Richard WilliamsSPEAKER_08

It does make sense. And one of the things that, that we see, particularly in the obesity sphere, is everybody wants to blame food companies for selling foods that Americans want to buy. It is a positive-sum game. You want to— you don't buy foods unless— they don't make foods unless you want to buy them. The truth of the matter is we started gaining weight in 1980. Since 1980, we have increased our calorie consumption. This is individuals eating more by 400 calories a day. That can lead to a lot of weight. So part of it is we have to look at ourselves. We're eating too much, and maybe some of that's because people are eating out. More and the portion sizes are bigger. But that's one of the things that, again, these devices can help with that. They can tell us maybe what to eat and how much to eat.

Rep. William Timmons (R-SC)SPEAKER_27

Again, I've had a scale for 6 years and it records my weight every morning. And that's another variable that we could put into the algorithm that determines the premium of your health insurance. If you're gaining weight, you need to pay more. If you're eating poorly and you're not sleeping, these are all things that factor into your health and can be used in underwriting. I'm out of time, Mr. Chairman. With that, I yield back. Thank you.

Chairman James Comer (R-KY)SPEAKER_17

Gentleman yields back. Chair recognizes Mr. Frost from Florida.

Rep. Maxwell Frost (D-FL)SPEAKER_29

Thank you, Mr. Chair. This past month, the FDA reported 15 food and drug recalls. That's about a recall every 48 hours. It was even higher in January and February. And many of these recalls were very serious. They were for things like food allergen cross-contamination, cancer-causing arsenic and lead, which can cause severe learning disabilities in children and miscarriages in adults. The past month also saw pet foods contaminated with bird flu. While these recalls save lives when folks are alerted in time, they also can cost working families time and money to replace recalled food. This year, tuna was recalled. That's about $3 per can down the drain. Prepared salads were recalled, another $5 each. Frozen dinners were recalled, 4, 5, 6 bucks a serving. These numbers might seem small, but folks managing a family budget know how grocery costs add up and what a waste it is to throw out food. Dr. Kessler, how does the work of the FDA's labs and inspectors help catch problems before bad food hits the grocery stores?

Dr. David KesslerSPEAKER_19

The laboratories are absolutely essential at that detection. Four FDA laboratories, two food labs, two medical products labs have been shut. Those recalls that are absolutely essential, the people who communicate about those recalls, the communications shops, have been gutted.

Rep. Maxwell Frost (D-FL)SPEAKER_29

Trump and Musk claimed that the mass layoffs at the VA and the Social Security Administration wouldn't impact the services, but we're seeing that's not true. Services for veterans, seniors across the entire country are getting worse. Wait times are at all-time highs. Now Trump and RFK Jr. are claiming that the mass layoffs at the FDA won't negatively impact food inspections. Dr. Kessler, how could mass layoffs at the FDA impact food inspections?

Dr. David KesslerSPEAKER_19

It will have a real and demonstrable effect. Yes, the inspectors have not been touched as of today, from what I can tell. But all their support, all their infrastructure, is gone. So all those inspectors can't get the supplies they need to inspect. They can't— they have to do their own travel. Their travel cards are not working. I'm not sure what the strategy is.

Rep. Maxwell Frost (D-FL)SPEAKER_29

And what does this mean for Americans' vulnerability to serious foodborne illnesses?

Dr. David KesslerSPEAKER_19

I fear that we are less safe today. I wish that were not the case, but you can't take thousands of people out of the FDA and not understand that you're putting the American people at risk.

Rep. Maxwell Frost (D-FL)SPEAKER_29

I'm one of the 33 million Americans living with potentially life-threatening food allergies. I've almost died, actually, because of an anaphylactic attack. Dr. Kessler, how could cuts to the FDA impact day-to-day safety of folks like me who live with serious food allergies?

Dr. David KesslerSPEAKER_19

The people who communicate, who share that information, who share that risk information, the people who write the policies that give the industry the guidance of what to put on the labels, they're not there anymore.

Rep. Maxwell Frost (D-FL)SPEAKER_29

Say we're lucky and these mass layoffs have no impact at the FDA with uncovering potential foodborne disease outbreaks before they spread. How will cuts to FDA staff impact the people who are still there, their ability to alert the public to the threat of allergen cross-contamination or an E. coli outbreak?

Dr. David KesslerSPEAKER_19

I think the effect of these cuts, not only on the people who've left, you know, and I'm hearing story repeat stories. I mean, about, you know, how these were done, when they were done, right?

SPEAKER_UNKNOWN

I

Dr. David KesslerSPEAKER_19

the the real thoughtless, careless, almost mean aspects of how these— this information was communicated. But people are getting up But people who have enormous expertise, tens, decades of expertise on those kind of questions, on those allergies, they're they're not staying at the agency. And recruitment, getting the best and the brightest, something that we all believed in, that we dedicated our careers to be able to go into these agencies and and provide that kind of public service, what signal is that sending? We're losing generations of future public servants, and that concerns me greatly.

Rep. Maxwell Frost (D-FL)SPEAKER_29

Thank you. I yield back.

Chairman James Comer (R-KY)SPEAKER_17

Chair recognizes Byron Donalds from Florida.

Rep. Byron Donalds (R-FL)SPEAKER_00

Thank you, Chairman. In 2019, President Trump warned of the horrible consequences of the Chinese Communist Party filling the void if Americans could not find federally approved tobacco products. To date, the Food and Drug Administration has only approved 34 vapor products, despite millions of applications submitted to the Center for Tobacco Products. The disastrous Biden administration instead allowed illegal Chinese vape products to control more than half the market. This is one of such products. This is Lost Mary. Flavor is ginger beer. Mr. Bentley, does the American consumer know what the contents of this Chinese vape are?

Guy BentleySPEAKER_26

Congressman, thank you for the question. Obviously, for that particular vape, I can't speak to its ingredients, but typically most vape products do have to register and register their ingredients if they are going to submit a premarket tobacco application form in order to get FDA authorization. But you highlight the important point, which is that millions of these products from American companies who manufacture, for instance, the e-liquids that smokers looking to switch away from deadly cigarettes want to use—those American companies have been denied authorization for their products, and instead illicit companies who often change their registration, can change their name, change the ingredients, are unaccountable to the FDA, have managed to fill the void. So now 18 million adult vapers, exactly as you point out, do not know what they're getting. And the FDA has lost control of the market completely unnecessarily.

Rep. Byron Donalds (R-FL)SPEAKER_00

Does the FDA even have a multiagency task force to combat the sale of illicit vapes?

Guy BentleySPEAKER_26

The FDA last year did, in collaboration with DOJ and CBP and other agencies, set up a multiagency task force to try and get a grip on the illicit market. But unfortunately, that's FDA passing the buck to other agencies already overstretched, like DOJ and CBP, when the solution for them, which wouldn't need any more staff, wouldn't require any more funding, is to change how they evaluate, how to authorize these products in the first place. They can do it quicker and better, as other countries such as the United Kingdom, Canada, New Zealand, Germany, France. All of these countries have tens of thousands of authorized e-cigarette products with no problem with mass levels of, for instance, youth vaping that we all want to reduce. So it is possible for FDA to change its practices and get the products that will save millions of Americans from smoking by switching to a safer alternative.

Rep. Byron Donalds (R-FL)SPEAKER_00

Let me ask you a follow-up question to that. Was the Biden administration aware of the numerous instances of illicit products that were showcased in the presence of FDA personnel at trade shows around the country?

Guy BentleySPEAKER_26

I cannot speak to what the Biden administration may or may not have been aware of, but it was widely known that this was a developing problem. Indeed, it was predictable and predicted that the minute you take off millions of products from the market, for which there is high demand, and that we must remember are dramatically safer than combustible cigarettes, then somebody is going to supply those 18 million adult consumers with those products.

Rep. Byron Donalds (R-FL)SPEAKER_00

Well, listen, to be clear, I'm not against Americans who want to use vaping products or tobacco products. I think it is important for the American people to understand that the previous administration did not do the job of making sure that there were products on the shelf where they could clearly understand what they were consuming or ingesting. And then you have products like this that have hit the shelves in the United States, primarily because the previous administration was derelict in their duty and making sure that they were— make— that they were approving applications of companies in America who could supply the demand from the American consumer. With that, Mr. Chairman, I yield back. Madam Chairman, I yield back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman yields. I now recognize Ms. Lee from Pennsylvania for 5 minutes.

Rep. Summer Lee (D-PA)SPEAKER_10

Thank you, Madam Chair. I think it's insulting that Republicans have set this hearing on restoring trust to the FDA while they're wholeheartedly backing Trump and RFK Jr.'s efforts to dismantle the agency. We used to do bipartisan work with the FDA, so why are Republicans politicizing it now? None of the actions taken have done anything to improve the health or safety of Americans. If RFK Jr. and Trump cared about things like protecting the public from unsafe medications, they wouldn't have illegally fired people responsible for making sure that the drugs we take are actually safe and effective. They wouldn't have fired an estimated 170 people from FDA's Office of Inspections and Investigations, which inspects factories to make sure the pharmaceutical companies aren't cutting corners. They wouldn't have fired the people and closed the labs that make sure our medicines are safe from contamination. They wouldn't have fired the people in the offices that check to make sure that drug companies aren't making false claims in their ads. They wouldn't have forced out Dr. Peter Marks, FDA's top vaccine regulator, while measles is killing kids, the same disease we have a 97% effective vaccine for and damn near eradicated. Dr. Kessler, looking back at some of the very events members of both sides of this committee did work on, like the infant formula contamination and shortage, how much worse could it have been if the FDA was short thousands of workers at that time?

Dr. David KesslerSPEAKER_19

These are very challenging problems. It took a lot of dedicated people working with both sides of the aisle on any of these. I've been there in these kind of crisis moments. And I fear that that infrastructure, the ability to handle those challenging problems, we've now gutted the agency.

Rep. Summer Lee (D-PA)SPEAKER_10

Mr. Chairman, or excuse me, Madam Chair, I'd like to enter into the record an article titled "FDA Planning for Fewer Food and Drug Inspections Due to Layoffs, Officials Say." Madam Chair?

Rep. Marjorie Greene (R-GA)SPEAKER_12

Without objection. So ordered.

Rep. Summer Lee (D-PA)SPEAKER_10

Thank you. Dr. Kessler, what is the worst-case scenario that could result from FDA's planned cuts to drug inspections? Is there anything that keeps you up at night around that? I think that's a yes, then.

Dr. David KesslerSPEAKER_19

I mean, people will die.

Rep. Summer Lee (D-PA)SPEAKER_10

Excuse me?

Dr. David KesslerSPEAKER_19

You want to know the worst thing?

Rep. Summer Lee (D-PA)SPEAKER_10

Yes, please.

Dr. David KesslerSPEAKER_19

I go back 1938. We forget the founding of the agency, right? Sulfanilamide, the '38 act, Congress acted. There were deaths in children because adulterants ended up in those medicines because we didn't have the inspection system, we didn't have the preapproval system. We've developed the most sophisticated system, right? So when you take a medicine today, what it says on the label is actually what's in the product. That's taken an enormous effort by the Congress over the last 100 years, working with dedicated scientists and public servants. Why are we putting that at risk?

Rep. Summer Lee (D-PA)SPEAKER_10

Yeah, I thank you for your candor, even as you hesitated to start. I think it's important that we speak frankly and plainly while we are watching what can or will be a catastrophe if we do not change course. Before the mess we're currently in, the FDA had been working with other agencies to prevent the spread of counterfeit and contaminated drugs coming in illegally or being made locally by people who would rather make a profit than make sure people have safe medications. Dr. Kessler, are you at all confident that the FDA can continue to do important work like that with the thousands of firings that Trump and RFK have initiated?

Dr. David KesslerSPEAKER_19

I am not confident. That that can, can continue. Congresswoman,

Rep. Summer Lee (D-PA)SPEAKER_10

Just last week, Trump and RFK Jr. also fired more than 800 staff from FDA's Center for Drug Evaluation and Research, which monitors medications for side effects and shortages, among other things. Dr. Kessler, do these cuts raise the risk that people might suddenly find themselves without access to the medicines they need?

Dr. David KesslerSPEAKER_19

I think that's a real risk.

Rep. Summer Lee (D-PA)SPEAKER_10

Thank you. My Republican colleagues want to sit here and pretend that everything is fine, and that somehow the FDA is actually better under the Trump administration. But just look at the fact that none of the witnesses the Republicans invited here today represent patients, healthcare providers, scientists, parents, or any of the rest of us who stand to lose from these firings at the FDA. Nobody in this country should have to show up at a pharmacy wondering if their blood pressure medication or their insulin is going to be in stock today. It's truly ridiculous and a tragedy that we have arrived at this point. To quote Dr. Marks in his resignation letter to the FDA, quote, "It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies." Thank you, and I yield back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentlelady yields. I now recognize Mr. Burlison from Missouri for 5 minutes.

Rep. Eric Burlison (R-MO)SPEAKER_02

Thank you, Madam Chair. And thank you to all of our witnesses for joining us today to confront the pressing crisis at the FDA. For too long, this agency has faltered, leaving hundreds of products' approvals stalled for years at times, while illicit vapes and counterfeit drugs from China flood our communities unchecked. The FDA's inaction has handed the Chinese Communist Party an open door to peddle dangerous knockoffs, threatening our kids and our sick, all while safer options languish under red tape. It's not complicated. Fix the FDA, fix their sluggish process, and ramp up enforcement and stop letting the Chinese Communist Party profit off of poisoning our children. Mr. Safdar, can you discuss the recent incidents of counterfeit drugs, particularly the GLP-1s that are that are flooding the market, the counterfeit ones?

Shabbir Imber SafdarSPEAKER_31

Yes. And thank you for the question, Congressman, fellow Missourian. We're seeing dangers to patients in three different areas in the GLP-1 space that are very concerning. There's lookalike counterfeits. It's a pen that maybe was an insulin pen where a criminal has pulled off the label and rewrapped it with an Ozempic label, for example, and then sold it to an unsuspecting pharmacy. Just discovered one of those in Arkansas at the end of last year. Clever and attentive pharmacist caught it and quarantined it so that it wouldn't reach a patient. Second category is we're seeing enormous

Rep. Eric Burlison (R-MO)SPEAKER_02

because how did that get in the hands of the pharmacist? So surely their supply chain is more reliable than that.

Shabbir Imber SafdarSPEAKER_31

The pharmacist was defrauded. What happened was there is a distributor in Florida who had obtained units of these counterfeit products and had obtained a license to distribute some products in Arkansas. It's not clear exactly what kind of distribution license they had, and they shipped it into Arkansas. So the pharmacist thought they were dealing with a licensed distributor who was licensed by their state board of pharmacy, and not until it showed up and the pharmacist had reason to suspect it was the pharmacist able to say, Okay, I know they have a license, but let me set that aside and call the inspector. And the inspector from the Arkansas State Board of Pharmacy came over and used a new tool we have because of the Drug Supply Chain Security Act called Pulse, made by the National Association of Boards of Pharmacy, and scanned it. And that barcode in under a second detected that Ozempic as counterfeit. And the Board of Pharmacy then moved immediately to suspend the license of the Florida distributor. It's a real great story of patient safety. Second category is we're seeing criminals selling illegal, research-grade pharmaceutical ingredients to Americans, and they're doing it through illegal foreign fake online pharmacies and even sometimes on e-commerce sites like Etsy. We've captured images of research-only

Rep. Eric Burlison (R-MO)SPEAKER_02

Etsy, people are buying

Shabbir Imber SafdarSPEAKER_31

Yes, unfortunately, I can even show you an example ad of what this looks like. And they're often labeled not for human consumption, but when you get them, there are instructions to inject yourself with them. And people are in fact doing that.

Rep. Eric Burlison (R-MO)SPEAKER_02

That's crazy.

Shabbir Imber SafdarSPEAKER_31

It is crazy. The third thing is one we just we just did a study about, which is freight shipments of semaglutide and tirzepatide ingredients coming into the U.S. that were not made in any FDA-approved FDA-inspected facility. And because they're freight, they have to actually come with a bill of lading that states the manufacturing location. And we found 179 shipments that were declared in in facilities that are not FDA-inspected. For example, a high school in Toronto, a gym in Toronto, and JW Marriott in Vancouver. None of these—I checked—none of these are actually FDA-inspected facilities. And yet, in some cases, they were let in. And so one of the improvements we would like to see from this next commissioner would be to actually refuse those based upon the bill of lading to show because if you know that that's not an FDA-inspected registered facility, there's no reason to even let it be shipped to the U.S. There's no reason to have to turn it around here when you know it's not going to be any better when it arrives.

Rep. Eric Burlison (R-MO)SPEAKER_02

Yeah, I have limited time, but I want to talk about the FDA's process of approvals. It's reportedly holding approvals for numerous generic drugs, even drugs that have shortages, about 238 drugs as of March of this year. How does this— how is— what's the impact of of this?

Shabbir Imber SafdarSPEAKER_31

So the drug approval process is actually not my specialty. I'm going to defer to my fellow witness, Dr. Kessler. Mr. Kessler.

Dr. David KesslerSPEAKER_19

Generic drugs are an absolutely essential part of what American families rely on. We need— and FDA has a responsibility to make sure we all have access to, you know, safe and effective generic drugs. But I'm concerned that that requires—

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman's out of time.

Rep. Eric Burlison (R-MO)SPEAKER_02

Thank you. You're back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

I now recognize Ms. Crockett from Texas for 5 minutes.

Rep. Jasmine Crockett (D-TX)SPEAKER_04

Thank you so much, Madam Chair. Are we tired of winning yet? We are hugely winning. We have the best of the best, right? Wrong. That was sarcasm, if you didn't catch it. The fact is, we should never have partisan politics playing a role when we're talking about something such as science. But unfortunately, in today's times, Democrats believe in scientists and experts and data, and Republicans instead believe in conspiracy theorists. And right now, that is who we have leading one of the most important agencies in this country is a conspiracy theorist, not someone who has an actual resume to get the job done. So why would anyone trust the Republicans on anything, let alone matters of public health and safety? It has taken Texas' largest measles outbreak in 30 years, with more than 500 confirmed cases and the death of two children, for the Secretary of the Department of Health and Human Services to say what we already knew: The most effective way to prevent the spread of measles is the MMR vaccine. This is the same guy who chaired the antivax nonprofit Children's Health Defense. Just last month, during an interview with Fox News, he suggested that somehow being infected with measles could provide protection against cancer and heart disease. The Republicans are implementing the most dangerous public health agenda in modern American history, and people are literally dying as a result. This administration doesn't believe in science. They're firing thousands of scientists and public health officials who keep our food and medicine safe, slashing funding for scientific agencies that help cities and states respond to public health emergencies, limiting public access to research and data that contradicts their misinformation. They're using financial threats to manipulate which studies the government will sponsor and blocking researchers from diversifying clinical trials. This reckless and chaotic approach will make it more difficult for the FDA to achieve its mission of protecting the public health of Americans. But there are two issues that I want to address before my time expires. Staffing at FDA has long been a challenge. The Government Accountability Office has identified several challenges at FDA as high-risk issues. One of the bigger issues the GAO has identified is FDA's extensive workload. Last Congress, the Senate held a hearing on the sale of unauthorized and illegal vaping products and e-cigarettes. During the hearing, Dr. Brian King, director of FDA's Center for Tobacco Products, testified that the volume of premarket tobacco product applications is overwhelming, so FDA is instead prioritizing its enforcement responsibilities when it comes to e-cigarette products. But just last week, Trump not only fired the director of FDA's tobacco center, he closed two entire offices responsible for drafting new tobacco regulations and setting policies. Dr. Kessler, in its 2025 High-Risk Report, GAO stated that, quote, "Stable senior FDA and center leadership remains of vital importance to the agency." How will this vacuum of leadership impact the public health and safety of Americans?

Dr. David KesslerSPEAKER_19

It will put Americans at risk. But you, Congresswoman, you raised a very, very important point. I'm the only pediatrician on this panel today, right? And your constituents, please, the most important thing is what you said. If you want to prevent measles, please have your children vaccinated against that very dangerous disease.

Rep. Jasmine Crockett (D-TX)SPEAKER_04

Thank you so much for that, Doc. And I only got 56 seconds, and I don't know if I'm going to go through my last question because you just— I'm looking at Greg to see if he going to make me do it. Listen, I'm going to I'm going to go off instead. Sorry. I appreciate the fact that you are an expert in this. And here's the reality. The Republicans and definitely MAGA loves to troll me in so many ways. And the reality is that I trust and believe experts. I don't believe that I know everything. I believe that I was elected by my constituents to make sure that I could keep them safe in all ways, making sure that they are not going to be victimized if they have, say, family members that are serving abroad because of Signalgate, because of that incompetence, making sure that they have access to vaccines if they need it, making sure that they can actually provide for their family because we have real economists that are— the

Rep. Marjorie Greene (R-GA)SPEAKER_12

gentlelady's time has expired.

Rep. Jasmine Crockett (D-TX)SPEAKER_04

Whether or not we are in a trade tariff war.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Gentlelady's time has expired. I now recognize Mr. Fallon from Texas for 5 minutes.

Rep. Pat Fallon (R-TX)SPEAKER_18

Madam Chair, thank you very much. A year ago, we held a hearing on the FDA, and at that hearing, I had the graphic behind me, and I, I'm I'm perplexed as to why things haven't changed. So I'm so glad that you all are here, and I really appreciate it, because according to the law, there's supposed to be premarket tobacco product applications supposed to be processed within 180 days. But unfortunately, the rolling average has been 3 years. And we bring this to light a year ago, and it doesn't seem like anything has changed. This is a picture from a shop a couple miles from where we are right now, and it's littered with illegal, smuggled Chinese vaping products. And so I don't want anybody to vape, and I don't want anybody to smoke, but it's their choice. And yet if they're going to vape, I want them to vape with a product that's American-made, preferably, that also went through a regulatory process. Not, we don't know, this is the Wild West. It doesn't make much sense. Mr. Bentley, what happens, let's say, if the FDA actually discovered it? Because I want to focus more on enforcement, because nothing has seemed to change. What happens if the FDA becomes aware of this shop and they're selling illegal products?

Guy BentleySPEAKER_26

The FDA— thank you, Congressman, for the question. The FDA can issue warning letters to distributors. It can also institute civil money penalties.

Rep. Pat Fallon (R-TX)SPEAKER_18

What do they typically do when they find this? What's the first—

Guy BentleySPEAKER_26

first defense? Often there will be warning letters about

Rep. Pat Fallon (R-TX)SPEAKER_18

a sharply worded rebuke.

Guy BentleySPEAKER_26

I agree, Congressman. It is absolutely nothing of a deterrent selling illicit products. And that is why how FDA has left the door open here, by making its own regulatory processes so complicated that, as you suggest, that American companies who want to do their best to tell what is in the ingredients, to sell products that are safer than cigarettes, those smaller companies have not been able to get through FDA review. So other actors will jump into the void

Rep. Pat Fallon (R-TX)SPEAKER_18

because there's a demand.

Guy BentleySPEAKER_26

That's exactly correct.

Rep. Pat Fallon (R-TX)SPEAKER_18

Prohibition did not work in this country in the '20s, did it?

Guy BentleySPEAKER_26

Absolutely not.

Rep. Pat Fallon (R-TX)SPEAKER_18

No. Okay. So they sent a sharply worded letter, which now everyone will ignore and not care about, and they're going to continue to sell. At what level do they typically at least confiscate?

Guy BentleySPEAKER_26

Now, I would not have the precise level of how much of the illicit market has been confiscated. I would assume it to be somewhere in the de minimis region, as you demonstrate there. This is just a few miles from this building and FDA, a few miles from FDA's White Oak campus. And the illicit market is still rampant.

Rep. Pat Fallon (R-TX)SPEAKER_18

But so it's not typical that once they discover it, they don't even just take it. They don't seize.

Guy BentleySPEAKER_26

No.

Rep. Pat Fallon (R-TX)SPEAKER_18

That's amazing to me. And I like that word de minimis. I'm going to have to put that in my vocabulary, particularly with a British accent. Sounds delicious. Dr. Williams, when did the American food— so I don't know if you know this answer, but I'm curious— when did we switch from mainly sugar to fructose, high fructose corn syrup?

Richard WilliamsSPEAKER_08

Well, interestingly, we haven't actually switched. For example, the colas, back when I was at FDA, what we found out was they would look at the relative prices of high-fructose corn syrup and sugar, and depending on the relative prices, they would choose

Rep. Pat Fallon (R-TX)SPEAKER_18

Well, when did— when did corn syrup enter the food supply in large

Richard WilliamsSPEAKER_08

quantities? I'm not sure of

Rep. Pat Fallon (R-TX)SPEAKER_18

I think it was in the '70s. I just think it's—do you happen to know, Dr. Kessler?

Dr. David KesslerSPEAKER_19

It was actually in the '40s and '50s. But you're right, Congressman, it then increased.

Rep. Pat Fallon (R-TX)SPEAKER_18

Do you think, Dr. Kessler, that that was one of the contributing factors to Americans' general problem with obesity? Yeah. Yeah. And it's just one of those things that I think we need to discuss more is preventative and not, you know, we spend more on healthcare than any country per capita in the world, I believe. But if we're preventative, you don't get sick in the first place, it's a heck of a lot better for the individual and for the country because you don't have that expense.

Dr. David KesslerSPEAKER_19

There is an enormous opportunity to make inroads in chronic disease. Congressman, as you're saying that, and I'd be— I'd love to be able to spend time discussing that with you.

Rep. Pat Fallon (R-TX)SPEAKER_18

Thank you. Uh, thank you to the witnesses. Thank you, Madam Chair. I yield back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman yields. I now recognize Mr. Bell from Missouri for 5 minutes.

Rep. Wesley Bell (D-MO)SPEAKER_24

Thank you, Madam Chair and Ranking Member, and thank you to the witnesses for being here. When I came to Congress, I made a commitment that public health and public safety would be at the core of my work. That mission becomes harder when agencies like the FDA face disruption, especially from actions like those recently taken by DOGE. Last month, DOGE abruptly announced it was canceling leases for 30 FDA field offices, including a critical 52,000-square-foot drug-testing facility in my district of St. Louis, described by former officials as the most important FDA drug-testing lab in the country. This lab exposed cancer risks in the drug Zantac and, just last month, triggered a recall of acne treatments with dangerous levels of benzene. Though DOGE and HHS reversed the decision days later, the damage was done. And so we must ask, are we putting the public at risk by undermining the FDA's ability to do its job? Are we creating conditions that allow unsafe or ineffective drugs into the U.S. market? The FDA plays a vital role in protecting public health, from food and medicines to medical devices. A key part of that is safeguarding the integrity of our drug supply. But right now, that work is under threat. Due to staffing cuts, the FDA has frozen a pilot program for foreign drug inspections and is planning to reduce both food and drug inspections. Just last week, 800 employees were cut from FDA's Center for Drug Evaluation and Research, or CDER. Cutting CDER staff will almost certainly slow the approval of new drugs and generic alternatives, which working families depend on to afford their prescriptions. Dr. Kessler, even if no food or drug inspectors were directly fired, how does a reduction in the Office of Inspections and Investigations impact FDA's ability to conduct inspections?

Dr. David KesslerSPEAKER_19

impact. And I just wanted to Congressman, that laboratory in St. Louis, it's one of the great laboratories in the world. It has enormous specialty expertise and can detect things that no one else can detect. But there are other laboratories that work more on a more routine basis that check surveillance of imports. Four of those laboratories were closed, right? That means more problematic problems products come into the United States. We need to have a robust laboratory system that can detect illicit and harmful products.

Rep. Wesley Bell (D-MO)SPEAKER_24

And, Dr. Kessler, how will losing 800 staff affect CDER's ability to approve new medications, especially timely, affordable generics?

Dr. David KesslerSPEAKER_19

Those Those officials were the officials who communicated with the public, who came up with creative solutions to the problems we've been discussing. And those people, they support— that's the infrastructure that supports the people who are looking at the applications. So what you're going to see is you're going to see increasing delays, right? Things that we worked hard over the last 20 years to eliminate. Those delays are going to manifest.

Rep. Wesley Bell (D-MO)SPEAKER_24

And Dr. Kessler, will fewer drug inspections make FDA better or worse at catching counterfeit or contaminated drugs?

Dr. David KesslerSPEAKER_19

It's going to make people less safe.

Rep. Wesley Bell (D-MO)SPEAKER_24

And quickly, what is the time— what is the cost difference between brand name and generic prescriptions? And how would delays in generics affect working families?

Dr. David KesslerSPEAKER_19

We all rely on generic drugs. I work very hard to make available life-saving medicines, but if people can't get access to them, if they can't afford them, right, what good is all that effort? Generic drugs are a very important part of the pharmaceutical armamentarium in this country.

Rep. Wesley Bell (D-MO)SPEAKER_24

The Trump administration claims these cuts are to Make America Healthy Again, but they will do the opposite. President Trump and Secretary Kennedy are slashing critical FDA functions while Republicans in Congress aim to redirect taxpayer dollars into tax cuts for the wealthy. The result? Americans will wait longer for cheaper medications, and it will be harder to trust that our food and drugs are safe. That's the last thing working families need right now. Thank you, and I yield back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman yields. I now recognize Mr. Burchett from Tennessee for 5 minutes.

Rep. Tim Burchett (R-TN)SPEAKER_11

Thank you, Chairlady. This is a question. These are some questions that I'm— what I'm trying to do is separate hemp from marijuana. All right.

SPEAKER_UNKNOWN

And

Rep. Tim Burchett (R-TN)SPEAKER_11

There seems to be a lot of confusion in that realm, especially when I walk into one of our hemp stores in East Tennessee when they see me walk in there. Mr. Miller, now do you support hemp products that contain intoxicating cannabinoids?

Jonathan MillerSPEAKER_30

We, we support any product that has less than 0.3% delta-9 THC, which is the measurement. Some of those products do indeed cause impairment, but at the same time we feel very strongly that they need to be strictly regulated and most importantly, kept out of the hands of children.

Rep. Tim Burchett (R-TN)SPEAKER_11

Okay, because doctors at East Tennessee Children's Hospital, where I spent a lot of quality time in my formative years during my Evel Knievel phase, as I called it, and this is a hospital in my district, East Tennessee Children's Hospital, they've reported that 56 newborns and over 30 kids have been exposed, or as they say, poisoned by THC products. Does that ring—does that sound right to you?

Jonathan MillerSPEAKER_30

I don't know the numbers, but there certainly is a real problem given the lack of regulation. And really the point of my testimony is that we need to get the FDA engaged particularly to get these products out of the hands of children.

Rep. Tim Burchett (R-TN)SPEAKER_11

I guess I'm just worried because kids are ending up at the hospital and there just seems to be, uh, the public needs to be educated on this issue, and I, and I'm not seeing a lot of that. It just seems the rules and regulations are kind of all over the place.

Jonathan MillerSPEAKER_30

Yeah, no, I know Tennessee has been making a strong effort to try to regulate these products. My home state of Kentucky has as well. Again, we feel very strongly that adult products are, when taken responsibly by adults, are a good health and wellness alternative, but we have got to keep these out of the hands of kids and we need help. We do our self-regulation as an industry. Our U.S. Hemp Authority helps crack down internally, but only if we get the federal government working with the states will we ensure that this problem goes away.

Rep. Tim Burchett (R-TN)SPEAKER_11

And I've talked to several people, some in this room actually, that support the legalization of marijuana but do not support it in the hands of children. And I'm wondering, how are we expected to trust y'all if if you condone the sale of these things like Delta-8?

Jonathan MillerSPEAKER_30

Well, we condone—we do not condone the sale of products like that to kids. That's 100%. Delta-8 is a product that many adults use and swear by for their own health and wellness. And as long as the products are regulated and make sure there's no contaminants, make sure they're labeled properly, and, again, make sure they're kept out of the hands of children, they can be a healthy alternative for adults. But you're absolutely right, it is a real problem. These products are dangerous for kids, and we're trying to do as much as we can as an industry, but we really need government regulation to crack down on

Rep. Tim Burchett (R-TN)SPEAKER_11

Is it true that compounded drugs are manufactured domestically under the oversight of the FDA or state boards? Does anybody care to answer that? Jump in there.

Shabbir Imber SafdarSPEAKER_31

Well, thank you for the question, Congressman. They are, but the FDA applies a different safety label to them than they do the branded or generic drugs. They're marked as FDA-unapproved drugs, and they are not guaranteed for safety or efficacy. So while they provide an important niche part of our drug supply to make it resilient, they're to— they're only used as a last resort.

Dr. David KesslerSPEAKER_19

But, Doctor, one of the key questions is those compounding pharmacies may be mixing the final ingredients, but where are they getting their ingredients from. And some of those ingredients, that API—

Rep. Tim Burchett (R-TN)SPEAKER_11

that's a— I know what API stands for. Now the rest of the community doesn't. So you'll explain to

Dr. David KesslerSPEAKER_19

active pharmaceutical ingredient. That first chart that I showed, 80% of our API is coming from either China or India, approximately. So that's my concern about the compounding: where is the raw material coming from?

Rep. Tim Burchett (R-TN)SPEAKER_11

Okay. Well, that was, I guess, the follow-up to that was we've got some compounding pharmacies in our areas. We do every other area. And I worry that the vast majority of them are doing the right thing, but I'm afraid some of them could be doing some folks some ill will. So thank you all. I've run out of time. Thank you, Chairlady, for your indulgence. Thank you, ma'am.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman's time has expired. I now recognize Ms. Pressley from Massachusetts.

Rep. Ayanna Pressley (D-MA)SPEAKER_09

Thank you. For decades, a known carcinogen, formaldehyde, has been allowed to seep into chemical hair straighteners, especially those marketed to Black women and girls. These products are advertised as tools for beauty and self-expression, but to be clear, they are contributing to a public health crisis. This is not dissimilar from the link that has been drawn between talc and talcum powder, baby powder, Johnson & Johnson, and a number of Black women who similarly suffered from ovarian cancer because of that link. Three in five Black women use these products, and according to the National Institutes of Health, they face a 31% higher risk of breast cancer. These women are also twice at risk of developing uterine cancer compared to those who do not use these chemical straighteners. And it's not just impacting consumers. Salon workers are regularly subjected to the constant inhalation of these chemicals. They disproportionately face asthma, burns, and long-term illnesses. Despite this clear and present danger, the manufacturers of these products continue to sell them. This isn't a coincidence. This is exploitation. This is profits over people. In March 2023, I led a letter with Congresswoman Shontel Brown urging the FDA to ban formaldehyde from chemical hair straighteners. The FDA proposed a ban that was scheduled for implementation under the Biden administration. Most recently, Trump froze all new regulations, leaving this rule in limbo. Dr. Kessler, the FDA's mission is to safeguard public health. Do you believe indefinitely delaying rules that have undergone rigorous research pose significant health risks to the public? Yes or no?

Dr. David KesslerSPEAKER_19

I believe that poses significant risks, Congresswoman.

Rep. Ayanna Pressley (D-MA)SPEAKER_09

Okay. I agree, and the science has not changed, and the harms are still real and ever-present. Dr. Kessler, or public health rules that have been made, that have made— for public health rules that have made their way through the regulatory process in the previous administration, what should the current FDA commissioner be doing?

Dr. David KesslerSPEAKER_19

One of the most dedicated public servants, the chief science officer, took on the responsibility recently for cosmetics, right, because cosmetics was always the least resourced, the least regulated. And Congressman, I applaud again your bringing this up. This has been a real issue. But Namandjé Bumpus, I mean, left the agency because she didn't think it was a place she could work anymore, and that concerns me.

Rep. Ayanna Pressley (D-MA)SPEAKER_09

concerns me as well. Thank you. In fact, just this morning, Congresswoman Shontel Brown and Nydia Velázquez and I sent a letter urging Commissioner Makary to act. There have already been some states, like Maryland, California, and Washington, that have banned formaldehyde from these products. But while these states have acted, they cannot solve the nationwide problem. It's clear that we need federal action to protect every woman, every worker, and every person who uses these products, regardless of where they live. In the courts, thousands of women have filed federal lawsuits against the manufacturers of these hair straighteners, alleging that their products have caused uterine cancer, breast cancer, and other devastating health outcomes. These lawsuits are not just legal cases. They represent the lived experiences of women who have been harmed by this industry. They are mothers, daughters, sisters, and they deserve justice. It's well past time we take formaldehyde off the market. We cannot wait another month, another year, or listen to another excuse. It's time to ban formaldehyde. Thank you, and I yield.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentlelady yields. I now recognize Mr. McGuire from Virginia for 5 minutes.

Rep. John McGuire (R-VA)SPEAKER_22

Thank you, Madam Chair, and thank you for our witnesses for being here today. I was listening to the discussions going back and forth today, and many of you said that there were dangerous ingredients in not just cosmetics, but our foods and other places. And I believe I heard testimony that many of these dangerous chemicals are coming from China. Is that correct?

Shabbir Imber SafdarSPEAKER_31

Yes yes, Congressman.

Jonathan MillerSPEAKER_30

Yes,

Rep. John McGuire (R-VA)SPEAKER_22

correct.

Jonathan MillerSPEAKER_30

Agreed.

Rep. John McGuire (R-VA)SPEAKER_22

So if these dangerous chemicals are harming the American people and they're coming from China, how do they get into our country? Would it be the cartels?

Guy BentleySPEAKER_26

Congressman, in the case of illicit tobacco products and e-cigarettes, whilst the market is underregulated because FDA has choked off the supply of authorized legal e-cigarettes, we do not know for some products what is contained in them. However, I would also make a caveat that might differ from some other industries. Almost every e-cigarette currently being sold or on the market, even if it is illicit, is probably still dramatically safer than a combustible cigarette and actually can provide

Rep. John McGuire (R-VA)SPEAKER_22

a public health benefit. Is it getting here through the cartels?

Guy BentleySPEAKER_26

It can get— in terms of e-cigarettes, they're mostly from China, not from south of the border.

Rep. John McGuire (R-VA)SPEAKER_22

understand they're made in China, but they've got to come across the border somehow. How do they get across the border?

Guy BentleySPEAKER_26

They get across the border because these products can be sold by e-cigarette distributors that can ship them in. They have tracking numbers that FDA can track, so-called STNs. So that's how they get into border through ports of entry. Some, however, are obviously not monitored and even outside of that regulatory system.

Rep. John McGuire (R-VA)SPEAKER_22

Okay, Mr. Miller, what do you know on this?

Jonathan MillerSPEAKER_30

I know very little. We've heard reports that Chinese-made purely synthetic cannabinoids—so these are products that were made completely out of a lab and not come from nature at all—we hear that they may be coming through the country. But again, because there isn't this regulatory, federal regulatory structure, we just don't have details and are unaware of the scope of their impact.

Rep. John McGuire (R-VA)SPEAKER_22

All right, Dr. Williams.

Richard WilliamsSPEAKER_08

Yeah I'm not aware of exactly how these things are coming in. One thing I am aware of, though, is fentanyl was just the start. They're creating things that are much, much more dangerous than fentanyl.

Rep. John McGuire (R-VA)SPEAKER_22

That's right. Well, I got to tell you, fentanyl is the one we know about. But you're right. I've heard there are different color versions of these drugs that are even more dangerous.

Shabbir Imber SafdarSPEAKER_31

Congressman, we have studied the routes by which illegal ingredients for knockoff weight loss medications have come into the country, and they come in both in freight—and I testified before, and my written testimony has some explanation of the report that we did where we studied these ingredients that came in through freight, and there's reforms that we could do to prevent that. But you're right, they primarily came from China and then India as a second. And then these products also come in through de-

Rep. John McGuire (R-VA)SPEAKER_22

minimis. Because of time, Dr. Kessler, do you have any knowledge of how they get here?

Dr. David KesslerSPEAKER_19

In December 2019, there was a decision, unfortunately, by the administration, if you talk about e-cigarettes, not to regulate in the disposables, and that opened the door.

Rep. John McGuire (R-VA)SPEAKER_22

So what I would say is many of these drugs do come in from the cartels. Now, this administration, thank God we got President Trump wanting to return manufacturing of drugs back to the U.S. and the border's been shut down for the most part. I mean, we've still got a lot of work to do. There's still certainly a threat, but that means less fentanyl, for example, is coming in. You think 100,000 people a year being killed from fentanyl overdose epidemic, we should be jumping up and down and making a lot of noise. So, not only are we stopping the fentanyl, we're stopping the flow of a lot of these other chemicals that are poisoning the American people. Now, earlier, you guys talked about high-fructose corn syrup being a danger to the obesity issue in our country. Mr. Williams, what about trans fats? How big a deal is that?

Richard WilliamsSPEAKER_08

Well, it's interesting. Originally trans fatty acids came on because there was a concern about animal fats. Nobody said, what's the replacement? If we take— if we don't use animal fats, what are we going to use? Nobody thought about the replacement. As so often happens in these decisions, they never think about the substitute. So we got trans fatty acids, which were much more dangerous for heart disease than animal fats. Now it seems like we're going back. The concern is seed oils. So let's get rid of—

Rep. John McGuire (R-VA)SPEAKER_22

How do we have Crisco on the label says 0 grams or zero trans fats per serving when it has trans fats in it?

Richard WilliamsSPEAKER_08

Yeah. How

Rep. John McGuire (R-VA)SPEAKER_22

does that make sense?

Richard WilliamsSPEAKER_08

I don't know about Crisco.

Rep. John McGuire (R-VA)SPEAKER_22

Oh, well, certainly an issue.

Richard WilliamsSPEAKER_08

But, but, but the issue is, is that before you make these decisions, you have to take something off the market. You have to know what's going to replace it.

Rep. John McGuire (R-VA)SPEAKER_22

Definitely. Well, I'm glad we're bringing supply chains and drug manufacturing in America to save our people. Thank you. I yield back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman yields. I just want to clarify something that's been said. There's an enormous difference between state-licensed compounding pharmacies compounding drugs on FDA's shortage list and illegal drug manufacturers making counterfeit drugs that they sell on TikTok. We must root out illegal drug manufacturers while ensure pharmacies have the ability to respond to drug shortages. Just wanted to clear that up. I now recognize myself for 5 minutes for for questioning, and I'm going to speak on behalf of a community of people that, here in America, that largely get ignored on an extremely important issue, and that's the issue of vaccines. And while we're talking about the FDA losing the trust of Americans, there's a very important reason why for that. And I I have to recognize autism rates. Now, anytime you mess with people's children, this this is getting to the heart of a family. And, in the 1980s, 1 to 4 out of every 10,000 individuals had autism. 20 years ago, it was 1 in 150. And just recently, the rate has been said to be 1 in 36. But today, there was a study that just came out of 12 million children ages 5 to 8, and it has been released by the Children's Health Defense that the autism rate is now 1 in 33. We are talking about something that cannot be ignored anymore. This is a crisis, and we are People are losing their children. They're watching their children go from being happy, active, babbling, growing, reaching milestones to completely disappearing. Completely disappearing. And parents, over and over and over again, point to vaccines, and they are they are called conspiracy theorists, they're dismissed, and they are completely ignored. And this cannot be ignored anymore. This is a crisis, and we are losing our children, and this cannot be allowed. Let's talk about another reason why the FDA has lost all trust from Americans, and we can talk about the COVID vaccines. Emergency use authorization was given for these vaccines, and the FDA took approximately 21 days to give it for the Pfizer-BioNTech mRNA vaccine. Moderna, the emergency use authorization was given in 18 days, 18 days. And then for Johnson & Johnson, it was given in 23 days. Now, this comes after typically vaccine development approval takes 10 to 15 years, but for these vaccines for COVID, it was given the emergency use was given in a matter of days, and then full approval was given in months. Now, what has been the result of that? Another thing and people that have been ignored. These are the These are the VAERS reports. Now, there's 1,662,426 VAERS reports. And it is listed here that there are 38,541 deaths, 220,494 hospitalizations, 156,527 urgent care, 17,913 Bell's palsy, 5,175 miscarriages, 22,247 heart attacks, 28,908 myocarditis, 77,311 permanently disabled. And these are people reporting themselves, and no one seems to give a damn. And this is why the people do not trust the FDA, along with the myriad of reasons that has been given today. And it's it's unbelievable. And at the same time, medicines that have been trusted for years, like ivermectin, one of the safest drugs, was called horse paste and has been one of the best effective treatments against COVID. Now, Mr. Kessler, did you object when Dr. Marks forced out the two top vaccine scientists at the FDA, Mr. Gruber and Dr.— Dr. Gruber and Dr. Krause, due to their opposition of mandating booster shots? Did you object to that?

Dr. David KesslerSPEAKER_19

I had enormous respect.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Did you object? Yes or no? Yes or no? I have a little time left. Yes or no?

Dr. David KesslerSPEAKER_19

No. But, Madam Chair, may I— may I

Rep. Marjorie Greene (R-GA)SPEAKER_12

respond? May I please respond? You did not object. You did not object. I

Dr. David KesslerSPEAKER_19

had enormous respect for Dr. Marks.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Well, I'm glad that you do, but you didn't object to him being removed when he said the booster shots should not be mandated, and people that have been vaccinated with COVID-19 are the people that keep getting COVID-19, and the people with the booster shots keep spreading and getting COVID-19. No, this is my time. Where people like me with natural immunity don't get it and don't spread it around.

Dr. David KesslerSPEAKER_19

Madam Chair, may I please

Rep. Marjorie Greene (R-GA)SPEAKER_12

Now, this is my time, Dr. Kessler, and my time has expired. So I now recognize the ranking member. Oh, Mr. Min has made it. I now recognize Mr. Min from California for 5 minutes.

Rep. Dave Min (D-CA)SPEAKER_06

I'd like to hear Dr. Kessler response to that last question.

Dr. David KesslerSPEAKER_19

Thank you so much, Congressman. I am a pediatrician here, and it just is very important to state there is no scientific link between vaccines and autism. Respectfully, on the issue on VAERS,

SPEAKER_UNKNOWN

you

Dr. David KesslerSPEAKER_19

VAERS is an open reporting system, and you have to look and ask the question. You have to apply scientific principles,

Rep. Dave Min (D-CA)SPEAKER_06

selection bias, things like that.

Dr. David KesslerSPEAKER_19

Bradford Hill, you're there. Congressman, please, you—

Rep. Dave Min (D-CA)SPEAKER_06

Facts are facts. Data is data, and a random website is not necessarily the best way to get any kind of real data. And we all understand, Dr. Kessler, the importance of peer review, don't

Dr. David KesslerSPEAKER_19

Exactly. We have to—the issue, just because you see a reaction in a database, you have to ask whether there's causation. There are certain Bradford Hill principles that have to be applied, and they were not being applied.

Rep. Dave Min (D-CA)SPEAKER_06

And it's unfortunate right now that science is being rejected by people going on Google, going on websites of dubious origin to try to find their own information.

Dr. David KesslerSPEAKER_19

We should all be concerned about that.

Rep. Dave Min (D-CA)SPEAKER_06

So I want to address—first, I want to thank the chair and the ranking member for holding this hearing on the FDA. It is, as we know, the gold standard in the world for drug and medical product regulation. Its critical work has included the regulation and approval of a wide range of products, ranging from the drugs we consume to the infant formulas that we feed our children. And of course plays a crucial role in cracking down on counterfeit medical products and drugs. That is why I believe the FDA should be fully funded and independent. It is absolutely essential, particularly today, to ensure a safe supply chain and that our products that we consume for our health have been properly reviewed for market. Now, under the leadership, quote, unquote, of current HHS Secretary Kennedy and Donald Trump, the great public health apparatus is in the process of firing thousands of workers at HHS, NIH, and the FDA. FDA has seen proposals to slash 20% of its workforce, including 170 of those from the Office of Inspections and Investigations. And I just want to note that when we talk about efficiency, that's a word that gets thrown around a lot, we have to actually talk about what we mean when we talk about efficiency. What is the timeframe we're looking at? What are the goals and parameters we want? If I want to lose weight, the fastest way to do that is maybe just cut off my leg. That is not an efficient way if you're thinking beyond the immediate term, and one can argue that the cuts to FDA are having a similar effect. In particular, I want to talk about the effects on the drug approval pipeline. And so my understanding—Dr. Kessler, I think you're in a position to answer this—that I've been told by a lot of the life sciences companies that I represent in Orange County, California, that those—many of those drug approval people are actually paid for by user fees. Is that your understanding?

Dr. David KesslerSPEAKER_19

CDER has resources that are paid for by user fees, but that does not guarantee that the application

Rep. Dave Min (D-CA)SPEAKER_06

of

Dr. David KesslerSPEAKER_19

course, will be approved. That's not

Rep. Dave Min (D-CA)SPEAKER_06

the

Dr. David KesslerSPEAKER_19

point. It just makes sure that there are people there who can review them.

Rep. Dave Min (D-CA)SPEAKER_06

And so I think the point I would like to make here is that by cutting these people, by terminating staff, you are creating potentially a much longer pipeline for drug approval, product approval. That is something that a lot of the companies I represent, including companies like Edwards Lifesciences and Masimo, some of the pharmaceutical companies I represent, are very concerned that they're going to see much longer approval processes. And again, these are positions that are paid for out of the user fees. They actually don't cost the taxpayer anything. And so when we look at efficiency beyond the anything but the immediate term, these cuts look very counterproductive. They look like they're going to have massive negative economic impacts on our communities, on the drug pipeline. And so I guess for you, Dr. Kessler, I just want to go back to you. How do you think drug approval times may be affected by cutting a blanket cut of 20% of the workforce?

Dr. David KesslerSPEAKER_19

I think that drug approval times will increase, but most importantly, important medicines that we will depend on for our families Those— that's what I care about.

Rep. Dave Min (D-CA)SPEAKER_06

That's right. Lifesaving medications are not going to get approved now or will take longer to approve.

Dr. David KesslerSPEAKER_19

I hope not. There are still dedicated people, but I fear that those delays are going to happen.

Rep. Dave Min (D-CA)SPEAKER_06

And when we talk about efficiency, I just want to note another thing that's happening right now. The attacks on immigrants, particularly in higher education, the cuts to NIH are having massive impacts on universities around the country, including UC Irvine, which I represent. They're very worried. I know that many of the immigrants that are researching potentially groundbreaking efforts in in new life sciences products and drugs, that they many of them are going back to their countries of origin. They're going to other countries and other top research institutions. I just want to ask, as my last question, Dr. Kessler, if you can speak about the administration's immigration actions and how you anticipate they might affect our our life sciences industry here in the United States.

Dr. David KesslerSPEAKER_19

Our competitiveness was enhanced by those people coming to universities in your district. They

Rep. Dave Min (D-CA)SPEAKER_06

made America great.

Dr. David KesslerSPEAKER_19

Exactly.

Rep. Dave Min (D-CA)SPEAKER_06

And now we are— the

Rep. Marjorie Greene (R-GA)SPEAKER_12

gentleman's time

Rep. Dave Min (D-CA)SPEAKER_06

is expired.

Rep. Marjorie Greene (R-GA)SPEAKER_12

In closing, I want to thank our witnesses once again for their testimony today. I now yield to Ranking Member Subramanyam for his closing remarks.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

Thank you, Madam Chair. First, I'd like to enter into the record some articles without objection.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Without objection. So ordered.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

L.A. Times article, February 13th, Trump assault on science will make Americans dumber and sicker; Washington Post article from April 2nd, Veterinarians working on bird flu, pet safety are fired in HHS purge; article on April 3rd in The New York Times, FDA layoffs could raise drug costs; an Axios article from April 3rd, Drug industry worries about FDA delays; and Washington Post article from April 6th, Worries grow over risks to Americans as Trump cuts health, safety agencies; finally, an Axios article from yesterday titled "FDA cuts threaten medical product review programs".

Rep. Marjorie Greene (R-GA)SPEAKER_12

Without objection. So ordered.

Rep. Suhas Subramanyam (D-VA)SPEAKER_28

Thank you, Madam Chair. We've heard today about the need to make sure our infant formulas and drugs are safe and affordable, about the need to prevent youth vaping, the need to stop illicit products from getting to kids, and even the desire to have the FDA approve things faster. But as our experts here today said, we can't accomplish any of this without the scientists, researchers, and staff in place. And these are the people the administration has started firing—thousands of people at the FDA. Someone said that running the FDA after these firings is like flying a plane with only a copilot. I think it's like flying a plane with only a flight attendant. It's such a difficult task already, and now you're firing many of the people who make it happen. And the title of this hearing is Rooting Out Illicit Products, but the very offices in charge of keeping us safe and healthy have been gutted, and the foremost experts on rooting out illicit products are being fired. We're worried about products coming into our country across the border, but 170 people were fired at the Office of Inspections and Investigations. And because of that, now the agency will have to, quote, "reprioritize their workload for the rest of the year," which would mean less surveillance, less inspections, and more products that are illicit or bad for our health coming across the border. We actually need more inspectors—16% more, according to the GAO—and all this is going to do is make it harder for the inspectors who are still here to do their job. But it doesn't end there. The administration is also stopping the work of Childhood Lead Poisoning Prevention Branch. Those are the people who are making sure that our children don't get lead poisoning. And just earlier this year, lead paint was found in school buildings of a 6th 68,000-student school district in Milwaukee. The school district called this lead poisoning prevention branch for advice, and they were getting advice up until last Tuesday, but now the people who were giving them advice have been fired. And as a dad of two girls, five and three, I can only imagine what's going through the minds of the parents in Milwaukee. And this administration is also cutting food-testing labs in California, one that tests for contaminants in baby food and for avian flu and other products. America has to lead the world in science, innovation, scientific discovery, technological advancements. And the American people deserve to live in a country where we can trust what's in our food, what's in our medications, and what's in our products. But cutting science funding and gutting the FDA, causing chaos throughout the agency, is going to make every American man, woman, and child less safe, less healthy. And the administration, if they don't reverse course, people will die. I yield back.

Rep. Marjorie Greene (R-GA)SPEAKER_12

The gentleman yields. I now recognize myself for closing remarks. The good news, ladies and gentlemen, the American people are not going to die under President Trump and his great administration because the goal is to make America great again. And as our new administration is getting in place, we have to talk about things that previously happened under the Biden administration. Things like the failures with infant formula, where mothers were desperately seeking formula for their children and were blocked from ordering safe formulas from overseas. That was a complete failure. I can't believe that any time in our country, mothers could not find infant formula on the grocery store aisles and were blocked from getting formula that they much needed for their babies. We can also talk about how the FDA bans raw milk, which is ridiculous. Raw milk is sold in countries all over the world, countries like England, New Zealand, France, Italy, Germany, Norway, Sweden, Finland, and Denmark. Raw milk has been here since the beginning of time. And many Americans not only produce raw milk, they'd also like to sell it. And many consumers would like to be able to buy it. But the FDA has declared war on anything natural and good, and while it allows many chemicals to be brought in into America, put in our foods, and distributed all over the country, no wonder obesity is at all-time highs. No wonder Americans are sicker than most people around the world. The FDA's failure to approve new nicotine products, which are safer than cigarettes, has spawned a massive and dangerous illegal market of Chinese vapes. No one trusts many of the products, especially anything laden with chemicals coming from China, because China, after all, has been murdering Americans for years now. And Americans are dying every single day from fentanyl that comes in our country. And if China wants to be serious about tariffs and its treatment and unfair treatment against America, the first step they should do is stop sending fentanyl in our country and poisoning our people. The FDA has failed to effectively regulate hemp-derived products, which the industry themselves desperately wants to be regulated. And we heard that in testimony today. The FDA has the authority to crack down on counterfeit drugs, which come primarily from China and infiltrate our legitimate drug supply chain, endangering American lives. And we heard our witnesses today talk about how we cannot trust China to give us life-saving medications. President Trump's recent executive order ending the de minimis package exemption for low-value imports will bolster bolster FDA's ability to restrict the flow of illicit products from China. And I think that's a great thing for every single American, no matter how they vote and how they feel about the current President of the United States. The reality today is it is very sad that Americans don't trust the FDA. And I will reiterate again, for the many millions and millions of Americans who are still angry and want accountability, and they deserve it, for being forced to take a vaccine they should have never have been forced to take, and all the Americans that suffer from side effects and lost loved ones from a vaccine that should lose its FDA approval. And I'm saying that, that is my own opinion. I believe that the FDA approval of COVID vaccines should be revoked and they should be taken off the childhood vaccine schedule. Children don't need a COVID vaccine. Children were one of the healthiest and had the lowest hospitalization rates and deaths during COVID. After all, our kids are resilient, and they shouldn't be forced and be injected with manufactured vaccines that their parents disagree with. I thank everyone for tuning in to this hearing today. I thank our witnesses for being here, and thank you for your testimony. With that, and without objection, all members have 5 legislative days within which to submit materials and additional written questions for the witnesses, which will be forwarded to the witnesses. If there is no further business, without objection, the committee stands adjourned.

SPEAKER_UNKNOWN

you.

Rep. Marjorie Greene (R-GA)SPEAKER_12

Thank you. Thank you. Thank you. Thank you.