would not survive, but that also kate cox's future fertility would be endangered and, in fact, possibly her life would be in danger. her doctor actually advocated for her to have an abortion. but the courts would not allow her to do that. at great danger to herself, she had to cross state lines when she was sick in order to have an abortion. her doctor actually agreed with her. yet because these abortion laws have gone to such an extreme level in the antiabortion states, people like kate cox, who simply wanted to have a child, had their life endangered. that is not right. host: we are talking with congresswoman judy chu, democrat of california. here is how you can join the conversation this morning. republicans, (202) 748-8001. democrats, (202) 748-8000.

independents, (202) 748-8002. text us as well, we will share those, at (202) 748-8003. roberta, san diego, republican, you are up next for the congresswoman. caller: i'm a little embarrassed you are up there. to begin with, you are one of the 70 people who did not even respect the people's vote when donald trump got elected to. i find anything you have to say to be two-faced, not genuine. i would say that since you and your democrat party have been running on

congress, subcommittee chairwoman mcclain launched an investigation into the infant formula crisis. her subcommittee revealed how the f.d.a. attempted to hide behind the covid-19 pandemic as an excuse for neglecting facility inspections and justifying poor performance. the f.d.a.'s tunnel work policies and lax approach to oversight were unprepared to address the short and issues. additionally, the biden white house and the f.d.a. took three months to act to increase production of infant formula. the result of these failures, barren shelves, leaving millions of young families unable to access the formula needed to feed their babies. we've also investigated the f.d.a.'s failure to prepare for and adequately respond to drug

shortages for essential medications used to treat heart disease and cancer just to name a few samples. f.d.a. and democratic policies like the inflation reduction act have dramaticly diminished the profitability of manufacturing generic medications. this has resulted in fewer manufacturers and a greater risk of shortage. the f.d.a. must improve coordination with manufacturers and federal agencies, including d.e.a., d.o.j. and d.o.d. to increase production. the f.d.a.'s failed to incentivize domestic manufacturing of pharmaceuticals, resulting in significant offshoring of these facilities. we conducted oversight of the f.d.a.'s failure to return to pre-pandemic levels of inspections of those manufacturing facilities for prescription drugs abroad. inspections of foreign manufacturing facilities were 79% lower in 2022 than 2019. last year alone this failure

resulted in two separate recalls of eye drops, manufactured in india, that caused an outbreak of dangerous drug-resistant bacteria, killing four people. through our investigation of tobacco products regulations, we learned the f.d.a. is failing to consistently and effectively regulate tobacco products. according to the reagan udall foundation, the f.d.a. has been reactive and overwhelmed in its tobacco products regulation. the f.d.a. has delayed review of applications for products that can retkaus hrarpl for many americans -- reduce harm for many americans. further, their failure to regulate has allowed unsafe and illicit products to proliferate. in fact, the united states court of appeals for the fifth circuit slammed the f.d.a. for sending manufacturers a flavored e-cigarette products on a wild goose chase. meanwhile, the f.d.a. is also failing to prevent illicit flavored tobacco products from china entering the country and harming americans. the f.d.a.'s not implementing

enforcement actions to address illicit flavored tobacco products in stores across the country. additionally, the committee examined the f.d.a.'s refusal to regulate hemp-deraved product -- derived products such as c. pw-frpt tk-frpt. instead of using its existing authority, the f.d.a. is requesting new authorities and money that it does not need. this is the f.d.a. putting its own bureaucratic priorities over the american people who can benefit from these products. the f.d.a.'s refusal to regulate hemp products is creating a significant confusion in the market and resulting in products with intock can'ts can -- intock can'ts that can be dangerous to americans who use these products. it is also halted business tying -- trying in good faith to enter the market while bad actors continue to thrive. finally, we found that the f.d.a. ignored decades of research regarding the ineffectiveness of an over-the-counter dekalb jest contaminant -- decongest ant, causing americans to waste their hard-earned money on a medication that's ineeffective.

these examples are just scratching the surface of the dysfunction and failures that are ongoing within the f.d.a. today i'm hopeful we can take a deep dive to understand how the f.d.a. is responding and taking action to ensure a safe food and drug supply. i now yield to ranking nebraska kin for his opening statement. mr. raskin: thank you very much, mr. chairman. and thank you to commissioner for being with us here today. the f.d.a. regulates everything from bottled water to infant formula, meat and poutry and egg products, prediction and nonprediction drugs, vaccines, medical devices, microwaves, personal care products and tobacco. during the biden-harris administration, the f.d.a.'s made critical progress to ensure that we have access to safer food and to effective drugs. for example, last fall f.d.a. acted quickly to investigate reports of lead appearing in

children's cinnamon apple sauce pacts for their school lunch. the cinnamon was adultered with lead which was added by the manufacturer in order to increase the weight of the product to make it more profitable in the process. however, the apple sauce contamination issue could have been completely prevented if end product inspections for food were required. the f.d.a. asked congress to amend the food, drug and cosmetic act as part of the f.y.2024 budget request to require that industry conduct testing of final products exactly for such contaminants and provide f.d.a. immediate access to those results. this would greatly help to ensure the safety of all of our food products for kids and for everyone else. but the f.d.a. needs these

additional authorities to make that happen. and, mr. chairman, i was very pleased to hear your opening comments and i hope you would join me in supporting giving the f.d.a. additional regulatory authority precisely to address the kinds of problems that both you and i have identified. the f.d.a. itself has proposed multiple shraugss that -- solutions that would address the problems we're talking about today. the democrats support greater and more refined regulatory authority to make our food and drugs safer and we hope our colleagues will join us. in the wake of infant formula and prescription drug shortage, f.d.a. also advanced leg legislative proposals earlier this year to strength notification requirements in data sharing. right now they don't have any authority to tell drug manufacturers to produce more drugs. one proposal they've offered would require manufacturers to notify the f.d.a., dealing with

this first problem of the applesauce, would require manufacturers to notify f.d.a. about pathogens that are discovered in certain critical foods. in the case of infant formula, this would prevent contaminated infant formula from reaching any more consumers and babies. a second proposal would expand f.d.a.'s authority to gather data interest industry about -- from industry about potential drug shorting ans and supply chain disruptions -- shortages and supply chain disruptions. the f.d.a. advanced the accessibility of medication abortion by removing the in-person dispensing requirement for a drug and allowing it to be distributed by mail through retail pharmacies. in july, 2023, f.d.a. approved the first over-the-counter birth control pill. as a result, consumers' access

to contraception has improved at a crit tal time when many -- critical time when many states are enacting increasingly draconian and oppressive abortion restrictions. f.d.a.'s also made srafplts to combat a -- made advancements to combat a range of life-threatening diseases. f.d.a. approved the first o. t-frpt c. -- o.t.c. opioid overdose medication, a step toward reversing opioid overdose deaths in our district. they also approved a new gene home editing technology to treat sickle cell anemia, a disease that has ravaged a lot of communities, primarily african-americans. this advancement is a crucial step towards treating sickle cell anemia and represents a break through in gene therapy. f.d.a. also secured additional supply chains in the wake of cancer drug shortages. it's crucial that f.d.a. continue to carry out its mission and create meaningful regulations based on sound

science and not conspiracy theories or ideological programs. public attacks on f.d.a. without any corresponding legislative solutions simply undermine its ability to effectively protect public health. anti-abortion activists brought a case against f.d.a. over its updated guidance on the first of a two-pill medication abortion. the activists claimed that f.d.a. did not properly collect data on drug risks and complications. however, this claim is contrary to the f.d.a.'s review of, quote, extensive research showing that it is safe, including to take it home, unquote. f.d.a. followed its standard procedure in reaching that conclusion and according to the f.d.a., it must act reasonably based on the information available, rather than act based on perfect data which seldom exists. if the objective of anti-abortion activists is to undermine f.d.a.'s authority, the consequences will be devastating to public health and

f.d.a. that bases its decisions on political science rather than actual science is not in the best interest of consumers. congress must ensure the f.d.a.'s empowered to rely on the facts rather than bend to the will of people pushing an ideological agenda. thank you, mr. chairman, and i yield back. mr. comer: the gentleman yields back. the witness will please stand and raise his right hand. do you solemnly swear or a.500 that the testimony you're about to give is the truth, the whole truth and nothing but the truth, so help you god? let the record show the witness answered in the affirmative. we appreciate you being here today and look forward to your testimony. let me remind the witness, i'm pretty sure you're an old pro at this by now, we've read your written statement, it will appear in full in the hearing record. please limit your oral statements to five minutes. as a reminder, press the button on the microphone in front of you so that it's on and that members can hear you. when you begin to speak the light in front of you will tush green. after four minutes the light

will turn yellow. when the red light turns on, your five minutes is expired. i now recognize commissioner callif to please begin his opening statements. >> thank you, chair comer, ranking nebraska kin, and members of the committee. thanks for the opportunity to testify about the food and drug administration's work to protect and promote public health. in the united states the safety of food and medical products depend on industry and the f.d.a. industry bears the responsibility of creating a supply of medical, food and cosmetic products that are safe and protect and promote public health. from that lens, i'd like to focus on the agency's work in

four main areas today. first, addressing vulnerability notice supply chain. second, reversing the decline in our national life expectancy. third, accelerating effective treatment for thousands of rare genetic diseases, and, fourth, undertaking the most significant re-organization in f.d.a. history with a focus on human foods and improving oversight of all of our regulated industries. as we saw during the pandemic and continue to see, we have a significant global supply chain vulnerability, including lack of redundancy and resiliency, and overreliance on foreign sources for critical products, particularly medicines and devices. preventing and mitigating supply chain issues in the industries we regulate have been a primary focus. in 2023 alone we worked with manufacturers to prevent over 230 threatened drug shortages. during the infant formula

shortage, f.d.a.'s use of temporary enforcement discretion enabled safe products to enter the u.s. market, which increased supply and doubled the number of firms producing infant formula for the u.s. from 2021 to 2022. f.d.a.'s continued oversight will be critical until supply chains are more resilient, particularly for infant formula. we'll continue to promote competition and manufacturing quality and implement modernized systems to respond to shortages faster. it's why we requested additional authorities that would provide more visibility into the supply chain. the trends in life expectancy and chronic disease in the rus concerning. and while we're -- in the u.s. are concerning. and while we're leading the world on new drugs and devices, our major cause of death and disability are driven by fundamentals. tobacco use, poor nutrition and lack of adherence to inexpensive, generic medications. given the burden of tobacco-related diseases, it's

encouraging that over the past year we've seen a reduction in cigarette smoking in the u.s. and a significant decrease in overall tobacco product use among high school students. primarily driven by a decline in e-cigarette use. despite these important wins, by a combination of education and enforcement actions, our work is not finished. we remain committed to reducing the health burden of tobacco product use in the u.s. food safety and improved nutrition are essential to combat the epidemic of chronic disease and premature death. the healthier food supply coupled with improvements in key nutrition information will help consumers make infor other purposessed health choices -- make infor other purposessed health choices -- informed health choices. this will help update the term healthy in advertising and create a nutrition center of excellence. thanks to congress' investment in the human genome project

decades ago, many of the approximately 10,000 rare diseases which impact at least 30 million americans can now be treated with gene therapy technologies. we're preparing to navigate a large number of these exciting therapies that will require new clinical trial methods, deep scientific review or expertise and development of reliable long-term follow-up systems involving electronic health records for real-world evidence. lastly, the agency has made significant progress in its proposed re-organization. the proposal aims to unify human food functions into the new human foods program under the direction of the deputy commissioner for human foods and to solidify the office of regulatory affairs' role as a front line of f.d.a.'s field-based operations. this will enhance our outbreak response and fully realize the preventive vision of the federal drug administration act. these proposed changes will

strengthen the agency making it more efficient and nimble and ready for the future with the ever-changing and complex industries we regulate. in conclusion, the essential work of the agency continues in thousands of work streams that americans and the world count on every day. thanks to the dedication and perseverance of f.d.a. staff. we look forward to continuing to work with congress on the agency's mission and thank you for the opportunity to testify. mr. comer: thank you very much, commissioner. we'll now begin the questioning phase. chair recognizes representative gosar from arizona for five mississippi. mr. gosar: i thank the chairman. now obviously the f.d.a. made a mistake in granting the emergency use authorization and license of covid-19 vaccines. it has been confirmed that the vaccines do not stop transmission. moreover, 1,634,000 injuries due to the covid-19 vaccine have been reported, including 37,382

deaths. considering that under 10,300 deaths have been reported due to all other vaccines combined, the harm due to the covid-19 vaccines is staggering. not to mention there is no accountability. legally it is impossible to sue covid-19 vaccine manufacturers for the injuries caused by their products. just last month the federal court forced the f.d.a. to retract tweets and statements for its years' long smear campaign against an effective treatment for covid-19. now let's enter ozempic. jpmorgan predicts that it and similar drugs will exceed $100 billion by 2030. concerningly, there's a plethora of federal lawsuits, 18 in all so far, alleging serious side effects from this class of drugs.

stomach paralysis and several severe indigestion, vomiting have been cited in the lawsuits. one woman claimed to have lost teeth from excessive and frequent vomiting. one law firm is investigating the claims of additional 10,000 people potentially harmed by this class of drugs. the plaintiffs predict 20,000 total people will be suing manufacturers of the glp1ra's in the future. the european agency is investigating ozemp kreufrbgs for suicidal ideation, according to forbes. also according to forbes, studies indicate ozempic and others like it may cause gal bladder disease, furthermore, a recent study linked ozempic to thyroid cancer. it's basically a synthetic hormone that tells your brain it is full, therefore deactivating digestion. as well as causing the

pancreatic raes to increase -- pancreas to increase insulin levels. does purposely paralyzing the stomach strike you as a healing type of remedy? it doesn't to me. it seems that the goal of big pharma is to get people hooked on it for life on their products. when it be an annual flu or covid-19 vaccine, perpetual stantons or lower cholesterol, beta blockers for high brood pressure, expensive, never-ending cancer treatments. yet it never seems to yield much fruit. chronic disease is skyrocketing. 40% of americans have two or more chronic diseases. are ozempic and related drugs the next big things big pharma is going to push on millions of people no matter the harms? the head of the f.d.a., should like to take this opportunity to

express your regret as head of the f.d.a., would you like to take an opportunity to express your regret in failing to curtail the chronic disease epidemic in america? mr. califf: i would like to respond. you raised so many issues and i've got a minute and 20 seconds. so i'll just start with the vaccine. which i think may be the most important one to talk about. so here's the progression as i see it. first of all, i'm pretty simple. i'm from south carolina. and i'm a cardiologist. i'm used to looking at life and death and seeing what the differences are. the question with any medical intervention, knowing that all interventions have risks and benefits, and the question is always do the benefit it's outweigh the risk? -- benefits outweigh the risk? the initial vaccine trial that led to the e.u.a. did show a dramatic reduction in the rate of infection in the two groups. the virus then mutated but the good news is now we have a progression of overwhelming evidence in every country, including the united states, --

[talking simultaneously] mr. gosar: i understand. mr. califf: you're less likely to be dead or admitted into the intensive care unit. if you live in a county with a higher vaccine rate, the mortality rate is lower. if you live in a country with a higher vaccine rate, the mortality rate is lower. so when you compare the two, yes, vaccines have side effects. the risk of being dead is lower if you're vaccinated. mr. gosar: ok, wouldn't you agree, this is my last question because i'm running out of time, don't you agree that the vaccine should have put into the fund or face liability issues? because the people were used as guinea pigs. do you believe in peer reviewed science? because there's another part that didn't get really reviewed very well. mr. califf: i'll remind you again, we always have to do studies or clinical trials to figure out the risks and the benefits. that's a normal part in most of my career. i personally participated in clinical trials when i have the chance. so that we can have the data and

the knowledge to make wise decisions and get vaccinated so we're less likely to be dead. mr. gosar: i get that but why do you have to retract everything you said about ivermectin? your office came out against it. i agree that there's some problems in the manufacturing of that dosage. but if in doubt, leave it out. mr. califf: we didn't retract everything we had to say about it. and in fact, -- we had an attack against ivermectin. mr. gosar: they ordered you to. mr. califf: if you look at the randomized trials and terror many of them now, -- there are many of them now, there's no benefit of ive rmectin in the treatment of covid. that's a fact. any drug for which there's no benefit in their risk, people have to make their own decisions about what to do. what we're plot doing is telling doctors what they have to do.

doctors have the right to prescribe. coal mine ko*ep the chair recognizes -- mr. comer: the chair recognizes the ranking member for five minutes. mr. raskin: thank you. i'm going to follow up on this because this exchange to me was extremely illuminating because what we have here is the commissioner as the head of the federal drug administration and then we get a drive bispray of prop -- drive-by spray of propaganda, disinformation and ideological attacks. so let me try to sort some of this out and maybe we'll help to illuminate why we have a food and drug administration, rather than leave it to politicians to make decisions based on ideological whim. but let's start with aoeufr iven which i believe is an animal deworming agent that some people were advocating for use to treat covid-19. has this been approved as a form

of treatment or a cure for covid-19? mr. califf: no, it has not. if i may, i should also point out, it also has benefit for humans with worms which is a huge problem in asia. so it actually won a nobel prize because it's an amazing drug both for animals and humans who have worms and there's good reason to think it may work in the case of covid and that's why thankfully the community, including the n.i.h., did a number of randomized clinical trials. there's just no benefit. that's true of most things that we try. there's nothing wrong with thinking it might work, it just doesn't. mr. raskin: what about another one that was advocated? mr. califf: basically the same story. there was really exciting preliminary work in the laboratory that said it may have activity against covid so the randomized trials were done. unfortunately no benefit. again, nothing wrong with thinking it may work and trying it out in a randomized trial. but then we have the data now so that leads you to the

conclusion. so we have not been able to grant medication for those. mr. raskin: i'm aware of a lot of political attacks and criticism against f.d.a. but i can never figure out the coherence of it. sometimes they seem to be saying, get out of the way and just let anybody advocate whatever they want and use whatever they want without any testing and without the various protocol us go through. and then other times they attack you because you don't have enough authority to do the things that we would want you to do in order to make kids' cinnamon applesauce clean, for example. so let's take that one which has caught my eye, since we certainly ate a lot of cinnamon applesauce in to our house when our kids were -- in our house when our kids were little. let's see. your f.d.a.-regulated products are manufactured or handled at something like 275,000 or 280,000 different registered facilities across the land. so what keeps you from

inspecting every private manufacturing facility that produces things like cinnamon applesauce or peanut butter? mr. califf: if i may, i'll try to do this very quickly. i think the best way to think about f.d.a. in general is we're referees. you all in congress actually write the rulebook, much like in any sport. it's the leadership that writes the rulebook. we enact what's in the rulebook. and in the case of food establishments, like most sports, the first line of defense are the players in the game. which are the -- is the industry that produces the products. and by and large they do a great job. but sometimes they don't. and as referees we have to be really wise about where we step in because we don't have an unlimited budget. so what keeps us from inspecting all 275,000? you don't have to be a brain mathematician to know how many people you'd have to have, but what we can do, for example, in food for children is to have the manufacturers be required to do

the testing. which is the way the drug system works. the manufacturers of drugs have to test every batch and in the case of cinnamon applesauce, if there had been mandatory testing, when it got imported into the u.s. from ecuador, the stores that were selling it probably would have picked it up at that point. mr. raskin: those kids ended up with lead poisoning, right? mr. califf: yes, it's a very serious problem and it causes chronic issues. mr. raskin: so you advocated mandatory testing? you would like us to give you that regulatory authority? mr. califf: yes. mr. raskin: and i hope -- i do hope that something that our colleagues on the republican side of the aisle would join us in, in the case of infant formula shortages, last congress we passed a bipartisan bill to help address those shortages, but nearly 200 house republicans voted against a second bill to give f.d.a. resources to strengthen its oversight and inspection of facilities to prevent shortages like that from happening.

we can have it both ways. if we want an effective, strong regulator, we have to give them the authority and the resources to get the job done. thank you very much, mr. chairman. i yield back. mr. comer: the gentleman yields back. the chair recognizes mr. grothman from wisconsin for five minutes. mr. grothman: thank you much. we're going to give you another covid-related topic. throughout the covid epidemic i spoke multiple times on the floor with regard to the value of is rightman difficult -- vitamin d. the adkwat level of vitamin d -- adequate level of vitamin d varies on who you talk to. 20nanograms, 30, 50. whatever the study you look at, the number of lives saved if everybody had adequate levels of vitamin d is tremendous. ok? it's a relatively cheap vitamin. but for whatever reason it was not pushed by the medical establishment and resulted, in

my opinion, in the deaths of hundreds of thousands of people. even the most moderate studies would say you're less than half as likely to die of covid if you had adequate levels of vitamin d and if you get up to around 50nanograms, you have a very, very small population dying. could you comment on why the medical establishment, including yourself, by the way, another thing that bothers me, if you went in for a checkup, medical checkup, during that time, they wouldn't even test you for vitamin d. which isn't all that expensive. because you get blood tests for other things you're doing. could you comment on the lack of emphasis of the benefits of vitamin d given that the evidence appears overwhelmingly helpful and very cheap? the lack of emphasis from the public health establishment on having vitamin d? mr. califf: well, as i've already said, you know, as f.d.a., this is really not in our domain.

the vitamin z is available on the -- d is available on the mark. we don't regulate the practice of medicine. that's determined by the medical profession. and other agencies. may have more to say about that but i would point out one key thing about vitamin d. just a very basic in my role as a person who has done clinical trials all my life, there are many diseases for which if you measure vitamin d levels, the higher the is rightman d -- vitamin d level, the lower the risk of the disease. it turns out when randomized trials have been done, where you take equal people and give some is rightman difficult, -- is vitamin d and other placebos, for most diseases turns out there is no difference. that's because people with higher levels of vitamin d are different in many other ways. they tend to be healthier and spend more time in the sunshine and all sorts of other things that are different. and the randomized trials so far on covid to the best of my knowledge have not been positive but i want to make the point, this is not something the f.d.a.

regulates. it's a dietary splement basically, a vitamin. it's on the market, it's freely available in your local store and that's between the doctor and the patient. mr. grothman: i'd like to sub mate couple of columns here -- submit a couple of columns here and i'll yield the remainder of my time to the chairman. mr. comer: without objection, so ordered. mr. comer: commissioner, i want to ask this question about tobacco. with tobacco and f.d.a.'s center for tobacco products, i think it's safe to say the current regulatory process at the c.t.p. is not what congress envisioned when it passed the tobacco control act 15 years ago. from the reagan udall foundation report commission and recent court rulings, i have to conclude that those seeking to play by the rules don't even know what the rules are. because f.d.a. won't tell them or f.d.a. won't put information out or they will put information out and then change it. so now after 15 years, f.d.a.'s granted only 45 authorizations

out of some 26 million applications and only five authorizations for modified risk tobacco products. while f.d.a. rejects applications based on science and data from manufacturers who have spent untold millions to comply with what they think the rules are, american store shelfs are overflowing with products from china. and your agency does not seem to be doing anything about it. so, given what i just described, i have to wonder, do you even want a functional regulatory process for these products or is it the objective to target the u.s. tobacco industry, even if it means allowing a flood of chinese products containing god knows what into this country? mr. califf: mr. chairman, you know, you're from kentucky, i'm from -- i grew up in south carolina. lived in north carolina and i was a cardiologist at a major medical center. i saw many, many people die from the ravages of tobacco. so the basics here, first of all, the major cause of remedial

death in the united states still today is tobacco-related illness. 460,000 people will die from tobacco-related illness this year. so we're very much intent on doing the very best job we can, starting with combustible tobacco and the good news is, as i said in my opening statement, we have a decline in that. what was not even present when the initial law was passed that you refer to was the presence of sraeuping or e-cigarettes. no one anticipated there would be 26 million-plus applications of sraeuping products. that is overwhelming. we're 99% done, including almost completely done now with the major manufacturers. but -- and so the own us congress -- onus congress gave us was a public health standard. when it comes to vaping products, it's the benefit of helping adults reduce use of combustible tobacco, the major killer, outweigh the risk of teenagers and children getting

addicted to nicotine which is a brutal, fierce addiction that's almost impossible to shake once you have it? and so far only 31 products last i counted have produced the evidence to meet that public health standard. all the others you refer to simply don't produce the evidence. now, if i could say a word about enforcement. i know that was the other issue. it bothers me as much as it does you to see what's on our shelves. but i do want you to know that we really picked up our enforcement. over 600 warning letters to manufacturers. hundreds of civil money penalties now and we've also now begun to do injunctions to stop. but every one of these cases, in an environment where every step we make ended up in court -- ends up in court inically cated -- in complicated lawsuits have us go back and take that into account. it's a battle every day.

we're engaged in it and we want to regulate it. the closer we can get to zero combustible tobacco the better. the role of vaping is still something we're working on. mr. comer: we'll get back to that. my team's expired. i'll have another round of questioning with that specifically. these products on the shelves that are getting the bad headlines are chinese products. that aren't even regulated by the f.d.a. f.d.a.'s regulating american companies. but the chinese companies are the ones that are the bad actors. so we'll get back -- my time's expired. i now recognize ms. norton from washington, d.c. we'll get back on that too. ms. norton. ms. norton: thank you, mr. chairman. mr. califf, across the nation and right here in the district of columbia that i represent, drug shortages are negatively affecting patients and their families. drug shortages can lead to daily challenges for patients, affecting every element of their lives, as well as health outcomes. for example, because of

shortages, an adhd medication, we have heard reports previously, of previously capable students barely able to pass grades. adults are forced to contact every local pharmacy to track down a medication that may be the difference between being productive and focused in the workplace on losing their livelihoods. drug shortages have occurred for decades and in the wake of recent shortages, the department of health and human services and the food and drug administration developed new proposals to prevent and mitigate shortages. earlier this month, h.h.s. released a white paper with potential policy solutions to address shortages. mr. califf, what shortages can the f.d.a. execute to mitigate

drug shortages? mr. califf: thank you so much for the question. i'll try to go quickly here because we spent so much time on this. this has been going on for decades. and most of what the f.d.a. do is to mitigate impending shortages when we know one is about to happen. but the way we do that right now is we have spotty pieces of information about what's going on out there from the manufacturers and we spend a lot of type on the phone finding manufacture b to make up for what -- manufacturer b to make up for what manufacturer a cannot do. we've given you a comprehensive list of the information we need. remember that most of the starting material now for our drugs is coming from china. the key petro chemicals that lead to drugs. india is a major player in the generic drug industry and so the supply chains are complicated and we only have pweuts and pieces -- by thes and pieces of -- bits and pieces of

information, we need more of it. you referred to other drug shortages and it may be worth quickly going through this. i don't want to take all your type. but i think of three kinds. the most common shortages by orders of magnitude are inexpensive, generic drugs. where, believe it or not, the price is not supporting the cost of manufacturing and distribution and quality. and the white paper you refer to as a lot of detail about this in it that i would refer you to. our supply chain pricing has hit a point where the price is below what kaoepts the manufacturing in the -- below what keeps the manufacturers in the game. when we find a problem and a supply line shuts down, that company may very well go out of business. now that's very different than the shortage of owe step pick -- ozempic which you referred to. there the manufacturer is making a huge amount of money with every dose. it's just that the demand is so much higher than they anticipated. that will take care of itself

over time. but you also referred to adderall which is a stimulus for adhd. very important because these drugs are highly effective for this problem and it's bad for students that have adhd to not be treated. unfortunately the very same chemicals are showing up increasingly in overdose deaths, the over 100,000 overdose deaths we have are typically a mixture of fentanyl plus something else, often a stimulant. the supply of these drugs is determined by the d.e.a., not by the f.d.a. because it's a scheduled addictive substance. so it's a much more complicated issue. the generic one is the one that we hope that we have now solutions in this white paper that have to do with fixing the economics of that industry. remembering that it's not just americans, the eight billion people in the world need a reliable source of generic

drugs. for the world, these drugs are really important to treat the chronic diseases that were referred to. right now in most low income countries, we just heard from a foundation that 80% of antibiotics in one country were actually fake drugs. so we have to have an industry that produces high quality at a low cost with a supply chain which is completely known and we need the data so that we can actually help intervene when there is an impending shortage like a supply line goes down or a company goes out of business. so we've asked for that and i hope we can get it. ms. norton: my time is expired. mr. comer: thank you. the chair now recognizes ms. mace from south carolina for five minutes. ms. mace: thank you, mr. chairman. commissioner cali if, f, thank you for being leier today and thank you for your work on scheduling -- thank you for being here today and thank you for your work on scheduling reform and your recommendation that cannabis should be moved to schedule three. while i and many cannabis advocates believe this does not go far enough, this is a long

overdue start. so my first question today is i understand this issue now rests with the d.e.a. and i'm curious if you have an update on the timing of their decision. mr. califf: we're both from south carolina. we know -- i can't -- i don't even know. but if i did, i couldn't tell you anyway. so the timing of the regulatory decision is something that would be up to the d.e.a., not up to me. ms. mace: do you think it will happen this year? have any idea? mr. califf: i know that there's no reason for d.e.a. to delay. i think they just have to take into account all the regulations that are in place. ms. mace: ok. thank you. if the d.e.a. concurs with the f.d.a.'s recommendation, can you help me understand if the f.d.a. will take on additional responsibilities or if your role will change as it relates to cannabis? mr. califf: this is a very complicated topic but i'll just say that cannabis, you know, remember, there are over 30 different forms of cannabis now, different chemicals are made and

it falls in this area where state regulation has been dominant. this is an area where i believe we would be better off if we had guidance from congress about how to proceed. because we're not -- medical marijuana is one thing where there's a medical purpose and it's proven through traditional medical pathways. but when it's used for recreational purposes, there is no medical benefit in that case. so it doesn't fall under our typical regulation. but what's in play with this and several other things that i think we'll probably talk with the chairman about here shortly like c.b.d., the question, is how do we reduce harm that's done when it's used inappropriately or a dose which is dangerous? or when it's packaged in a way to market it specifically to children? we're seeing some of this stuff packaged in gummy bears that easily mistaken for children's candy. but we're going to need help in

a regulatory pathway, remembering that almost everything we do, there's a health benefit. like, you create a new drug or a new device or a food for a health benefit, this is an area of harm reduction when it's used recreationally. ms. mace: right. well and also, it reduces the morbidity and the addiction to opioids prescribed by doctors too. there's just a huge amount of benefit. i've seen it benefit in my own life and welcome to my world, i'm a mom of teenage kids. i've seen packaging of things, i see what kids are bringing to school, even in a state that prohibits cannabis, kids are doing it all over the place. and i have a bill called the states reform act, it puts -- there's a balance between federal regulation and also regulation amongst the states but one of the things you mentioned was about packaging. myself, like my colleagues, we're concerned about the safeguards for our youth and one of the things in the state's re-- states' reform act is it addresses the packaging that should not be marketed like it's

candy or a candy bar or chips or whatever kind of candy is your favorite. in south carolina i understand these products, so i'm concerned about safeguards for youths and intock kating hemp derived products. in south carolina these are not age-gated or appropriately tested and many of the packages resemble candy or snacks and that sort of things. so for my family it's an ongoing conversation about what looks cool and looks like it might be a fun and exciting, really is not, especially on a young brain. mr. califf: without revealing too much about phaou age, i'm a child of the 1960's. so it would be nice that within my lifetime we came up with a regulatory scheme where i think, whatever your belief is about use of the product, where these safety issues that you've referred to are written into law so that we have a scheme whereby we can regulate it. because if it's not writ noon law, then we're, -- written into law, then we're, like i said, we're referees.

you write the rules. we need the right rulebook in order to play the referee role. ms. mace: i would encourage you and love you to review the states' reform act that takes into account the regulatory side and the federal side but also states being in the driver's seat but one of the imp positions in the bill is -- impositions in the bill is making sure we don't market to kids. things aren't packaged to children. i only have 20 seconds left. while i firmly support the right of americans to make choices about what to put in their body, we can all agree it is a desirable outcome for less people to smoke cigarettes, the negative health effects of which are well known. any comment on alternative non-nicotine products today while year haour in five obg -- while you're here in five seconds or less? mr. califf: there's several categories. medications is one category where i hope we'll see more in the pipeline, it's not robust. when it comes to chemicals that are synthesized that also cause -- activate nicotine receptors,

they also cause addiction to nicotine. so we've got -- and the inventiveness of entrepreneurs in this area is profound right now because chemistry has gotten so much better. so there's some things i'm very concerned about in non-tobacco nicotine and even compounds that are one component removed from nicotine which may even be more potent in terms of addiction. ms. mace: thank you and i yield back. mr. comer: the gentlelady yields back the balance of her time. the chair recognizes mr. lynch from massachusetts. mr. lynch: thank you, mr. chairman. dr. califf, welcome, thank you for your good work. in march of 2024, the f.d.a. issued a proposed rule regarding electrical stimulation devices that are intended to reduce or stop self-injurious or aggressive behavior in some patients. the proposed rule would remove these electric stimulation devices from the market and debt vices will no longer be --

devices will nothing beer considered legally marketed. i've tried to read as much as i can on these. as an attorney i try to refrain from making medical decisions on my own. especially for my constituents. i do know that the geneva convention regards these devices as torture. but i also have a group of families in my district who have children and loved ones who are undergoing these treatments and they claim that those treatments help. now, as a result of this rule, these treatments will go away and my constituents have asked me to ask you and the f.d.a. to meet with them to talk about the consequences of the f.d.a.'s rule. and so as a member of congress, on behalf of my constituents, and i'm asking you and all your staff to provide an opportunity

for those families to meet with you and to discuss their concerns. mr. califf: well, thank you for bringing this up. i know it's part of your duty to do so. this is a very tough issue and i have worked in psychiatric wards during my career and i think most people can appreciate the anguish of families who have loved ones who are in a situation that might call for this or other serious mental health problems but anyone who has been through it i think has a special feeling about it. as i think you know, there's a proposed rule that we've now put out there, a docket and we do encourage everyone to submit their comments and views to that docket. i will definitely take this back to our staff. i know that our staff has met with these families before but this has been going on for a while so we'll go back and reconsider. mr. lynch: it has and it's heartbreaking. let me ask you, so, shifting to something completely different.

last year the f.d.a. made nearly 200 additions to its public list of a.i. and machine learning-enabled medical devices currently marketed in the united states and there's been some wonderful success. you know, dana tpaurber -- farber cancer center is near and dear to my heart. mass general brigham, their cancer center as well. wonderful, wonderful progress in diagnosing breast cancer from mammograms. clearly there are enormous potential benefits here. but there's also some concern around privacy and also the lack of explainability of some of these alge reuplgts that are -- algorithms that are being used on a diagnosis or the predictive end. what are we doing to mitigate the negative aspects of the use

of a.i. and i know it's coming at us hot and heavy in so many areas, but i'd like to hear what the f.d.a. is doing about tpwarding against -- guarding against the dangers that might be present by this widespread adoption of a.i. mr. califf: thanks for the question. i'll have to contain myself here but a you may know that i worked -- because you may know that i worked at alphabet google during my years and very heavily into this and i think it's going to be a huge benefit but also a huge risk on the other side if it's not regulated. also, we have many mutual friends, albeit it -- i'll be at mass general next week as visiting professor and learning from the people in the harvard system who know a lot about this stuff. this is one of the topics. the thing i would emphasize is that i don't think it's explainability that's really the issue, and i think an easy way to this by this, think about it

yourself before you had a map in your car that you could talk to. when you used to drive the car and you get in an argument about which way to go and then you'd have to pull out the map and look at it. well, now you just talk to your car and what's going on with the car is a.i. continuously in real-time take into account everything that's happening on the roads, the template of what's there, and your personal preferences that it learns as you go along. .... if a.i. works we'll take 2 for granted f you ask me how does aspirin work. we know a lot about aspirin. but how it works for each disease we are not sure. we know it does work for particular things. what we are focused on is create ago community in our health systems and the industry that, like i have already said, we are referees, we thing the first line is self-regulation by the industries. what's really important, where a.i. is going, generative a.i.,

it learns as it goes. the more information it has either the better it gets or the worst it gets. you don't know which one. if you just put it in place and don't tend to it and monitor t. it can go wrong in really bad ways. i saw that at alphabet. it was something we were worried about. we have to reforemeant our health system as time goes on you are constantly looking at what the algorithm is doing. are the predictions accurate. right now we are not configured to do that. we are working very much with the community of health systems and the industry to come up with a scheme of what's called assurance labs. this would be you sell your a.i. thing to somebody. it goes out there. there's going to be a monitoring that says it's either working or it's not in practice. and it also looks for the spies we are all concerned about that if you put the wrong information

in you end up with a prediction which is preferential to one type of person compared to another. that's got to be looked at. i'll stop there. i could go on a while. mr. lynch: thank you for your answer, doctor. mr. chairman, thanks for your indulgence. i yield back. commissioner califf: the chair recognizes -- mr. comer: the chair recognizes mr. sessions. mr. sessions: as you know the cardiologist spending time in mental health stress units. part of what aim going to talk with you about we come directly to observations that you made strong -- may strongly identify with. in august of last year, assistant secretary for health sent drug enforcement agency director ann a recommendation from the f.d.a. to downgrade marijuana, also t.h.c., from schedule one to schedule three. under the control substances act. this recommendation made the claim that marijuana meets the

criteria for control under section 3. in review the -- reviewing the f.d.a.'s recommendation, i do not believe the f.d.a. did not base its assessment in scientific fact or realities of how marijuana is being abused and used in our country today. the f.d.a.'s assessment relied on, i think, cherry picked data. for example, concluding in the report that since the potential for abuse of marijuana is less than heroin, marijuana should be downgraded. this completely ignores the realities of a drug that is causing enormous consequences of children and adults in our country. high schools, middle schools, and communities. just last week bloomberg editorial board published an article emphasizing the sharp rise in marijuana t.m.c. related

traffic fatalities. one analysis which is consistent with the hidta report out of colorado, a 10% increase in virginia tech hrar deaths. in california the increase was 14%. in oregon, 22%. nearly 50% of the deaths on a highway the driver had t.h.c. in their blood. those are only the marijuana related traffic death that is we know about. we know that there are other problems. in your agency's analysis you scrap the long held five factor test for terming a drug's medical necessity to simply two factors. two factors that relied on the fact that marijuana as was reported currently is accepted for medical use because it is prescribed by health care

practitioners through medical marijuana programs. so what i would ask you is why did the f.d.a. create a new less regular russ, two factor test tt when you know the reams of data and evidence suggest it's not only addictive but a contributetory to not only death but long-term stress of people who use this and confirmed by the medical community. commissioner califf: sir, i appreciate the question. i think you have already demonstrated between you and the other representative that there is not agreement in congress about what should be done with this. again, we would very much appreciate if congress did come to a conclusion for the country. mr. sessions: congress has not spoken because we believe it's a dangerous product. we receive calls from thousands

of parents every year about their children. we see drug related not only instances in schools but principals, teachers, people report the real problem. and the problem gets even worse as gum byes -- gumbies are introduced. commissioner califf: i appreciate those concerns. let me remind you that a schedule 3 does not put marijuana on the market in the united states. mr. session: it does not. you do know what it does do. we suggested that it's not a dangerous product like heroin. well, neither were cigarettes like heroin. commissioner califf: well, with all due respect i think it is differential from heroin. mr. sessions: i think it is, too. commissioner califf: i appreciate you feel that way. and your colleague just gave exactly the opposite -- mr. sessions: she talked about

the public opinion. not the medical opinion. you are a medical doctor. a cardiologist. you were here to answer and i thought you did do a fair job to answer that you do see where when not used properly it is a dangerous product. and it is a dangerous product. and i thank you very much. i appreciate you being here today. mr. chairman, i yield back my time. chair comber: the chair recognizes mr. krishnamoorthi from illinois for five minutes. mr. krishnamoorthi: dr. califf, in february 2021 i was chair of this house oversight subcommittee's economic and consumer policy subcommittee. we studied the presence of toxic heavy metals in baby food at that time. in march of 2021 we issued a report with regard to the presence of lead, arsenic, cad me yum, and mercury at astonishing levels in baby food products. we found baby food had on average 177 times the

permissible amount of lead in drinking water. in response to public pressure off that report, f.d.a. issued an action plan called closer to zero. this was the first time f.d.a. would be regulating toxic heavy metals in baby food, which is a good thing. when my subcommittee issued its report in march of 2021, f.d.a. said that it would issue its initial draft guidance regarding permissible lead limits in baby food within one year. roughly april, 2022. instead it missed that deadline and issued its draft guidance in 2023. let me talk to you about some of the other toxic heavy metals in baby food that are covered by the closer to zero program. i want to throw up here a screen shot of your website from today. specifically i want to talk about when you say final guidance will be issued with regard to permissible limits of

other toxic heavy metals. in terms of when, for instance, arsenic, in baby food would be examined and you would be issuing final guidance on permissible levels. your website says, this is my red circle, no update. that's what it says, right? commissioner califf: i'll take your word for it. i can't see it from this distance. mr. krishnamoorthi: let me talk to you about cad me yum levels -- cadmium levels. screen shot from today. you say we should expect final cadmium levels at some undetermined point. again, your website says no update. you don't disagree, right? commissioner califf: i'm not up-to-date on the exact, i assume that you're telling the truth here. mr. krishnamoorthi: thank you. mercury, a dangerous toxic heavy

metal in baby food. again, we go to your website and with regard to when we should expect to hear from you with regard to permissible levels of mercury in baby food, you say no update. right? commissioner califf: you say it. it must be so. mr. krishnamoorthi: dr. califf, this is unacceptable. completely unacceptable. it's been three years since we issued that report. the public, the parents are outraged about the amount of toxic heavy met kals that -- metals that are present in baby food. quite frankly, sir, i respectfully say your closer to zero program at this point is closer to zero updates. that's very, very disturbing. i want to turn my attention to another topic which is the youth videotaping epidemic. you and i have spoken about this before as well. your own 2023 survey indicates that 10% of middle and high

schoolers are videotaping today. 90% of them preferred, prefer flavored videotapes. and the -- vapes. the vast majority of those flavored vapes are illicit vapes come interesting china. here's one right here. it's a strawberry mango e.b. create vape. it's illegal. but you can buy it today because you folks have not cleared the shelves of these illicit products. on december 7, 2023, a dozen of us wrote to you asking for a comprehensive approach to dealing with these illicit chinese vapes. and you didn't respond to me at that time, did you? commissioner califf: i have to go back and look. we have had much correspond about this issue. mr. krishnamoorthi: you are too busy to respond to us. it's been five months. after that we wrote you february 1, 2024.

again, same issue. we want to know how you're going to deal with these illicit vapes from china. you didn't respond to that one either, right? commissioner califf: i have to go back and look. mr. krishnamoorthi: sir, what bothers me about your answers is this, the reason why you didn't respond to us with your approach to clearing the shelves of these illicit vapes from china is perhaps because you don't have an answer. it's because you don't have an approach. and i -- mark my words, the illicit vapes coming from china, flooding our market, these kid-friendly flavors such as the ones here, or the ones i hold in my hand is the next chapter in this youth videotaping -- vaping epidemic, it's time you take this seriously. i yield back. chair comber: the gentleman yields back. the chair recognizes dr. foxx from north carolina for five minutes. ms. foxx: commissioner can live,

the certainty for tampa bay product or c.t.p., must make ly decions on whether products, especially tobacco, harm reduction products, can be allowed for sale or not. however, stakeholder groups with pending premarket tampa bay product applications -- tampa bay product -- tobacco product applications, have been waiting for several years which far exceeds the 180-day review period written into law. can you tell me in 25 words or less why has the c.t.p. failed to comply with the statutory review period despite the fact that the c.t.p.'s staff has more than doubled in the last decade? commissioner califf: less than 25 words. it's 26 plus million applications. we are now 99% done. and soon we will be within that time frame. ms. foxx: you know among those

applications are very frivolous applications. and there is a couple dozen in there that are coming from legitimate places. and you all should have focused your attention on those. it's hard to believe that an agency that's doubled its staff over a decade to over 1,200 receives over $700 million a year in funding. you are still not meeting the deadline for these pmtas, the serious ones. it's my understanding relatively few serious from legitimate companies. what steps are needed to bring more accountability to the c.t.p.? commissioner califf: i would remind you that the vaping industry right now pays no user fees. all the money and people that are hired, are hired off the combustible product industry. there we have tremendous gains. in terms of the transparency now the applications, people can track it. the information is published.

you are seeing continuous improvement in our efficiency. ms. foxx: what performance metrics does the c.t.p. have to ensure there being good -- they are being good stewards of the tobacco user fees? commissioner califf: the numbers of applications, the time it takes to review them, the outcomes of the reviews are discussed by numerous watchdog groups that are looking at everything we do. ms. foxx: had the c.t.p. done its job over the last decade, there should have been tampa bay harm deficit reduction -- tobacco harm rudd products approved. there's a command for these products filled by illicit flavoredded disposable e seg tkpwrets. mao making up the ends market most of which from china. what is the f.d.a. doing to rectify this problem of illicit products in the market? commissioner califf: if i may,

tobacco harm reduction product is an industry term. i would say we are all in favor of reducing harm from tobacco. as i went over with an earlier question, we have an increasing number of warning letters, civil money penalties, and injunctions now and seizures now at ports o. it is a very large number of products. there is no question about it. it is a big job. and we have a lot more work to do. ms. foxx: commissioner, you have recognized the critical need for the public to have access to accurate medical and scientific information to help inform the decisions they make about their health. how does the f.d.a. justify the decision to spend millions on ad campaigns and scare tactics such as brain worms or metal dragons that are not based on verifiable facts? and when will the f.d.a. focus on the facts about what can make cigarettes deadly as congress

intended in the tobacco control act instead of relying on mis understandings and outdated narratives? commissioner califf: i'm not sure i follow that question. i would just say we have seen dramatic progress in reduction in combustible tobacco use. significant reduction of number of people dying. it's sill 460,000. i'll note in my time at alphabet i learned a lot about advertising. i think our statements are based in fact. they include a component to reach into the culture of people that need to receive the information. simply stating a fact, when you are talking to a teenager, is not necessarily the best way to reach that teenager. you need to have the mind prepared to absorb the information. ms. foxx: so brain worms and metal dragons -- commissioner califf: i don't know about those. i'll take your word that something alluding to that must

exist somewhere in there. ms. foxx: thank you, mr. chairman. i yield back. chair comber: the chair recognizes mr. khanna from california for five minutes. mr. khanna: thank you, mr. chair. commissioner califf, thank you for your service. so many americans are frustrated even with insurance they are having to pay thousands of dollars for drugs for cancer, for multiple sclerosis, for getting inhalers. hundreds of dollars. i want you to help explain to the american people why this is happening. and to start by giving two sentences on what the f.d.a.'s orange book is. commissioner califf: well, the orange book is a listing of patents that are relevant to drugs that are marketed. mr. khanna: if something is listed on the orange book, is it correct for 30 days -- 30 months a generic manufacturer can't produce that? commissioner califf: with some caveats. essentially that's a fair statement. mr. khanna: take a couple of

examples. you have a multiple sclerosis drug proud by teva. it costs patients between $3,000 and $50,000. it is currently listed on this orange book. the company producing it is going to come, again, to have it listed with no real changes to the drug cosmetic changes. if they list it again, no generic manufactured drugs can be produced, correct? for 30 minutes months? commissioner califf: it's a little more complicated than that. you left out one step. before that. which is you have to have a patent which says it's a significant new thing. our role in the orange book is ministerial. we list -- mr. khanna: you have correction whether to list it or not? commissioner califf: not much. mr. khanna: technically you have that discretion. commissioner califf: not really. we have to list them. mr. khanna: what would happen if you didn't? commissioner califf: we would get sued.

mr. khanna: you have these companies that are getting you to list this and not have generic competition. and so then as a result of it the american people are paying $50,000 for drugs on multiple sclerosis, or in the case of a drug for leukemia they are paying $17,000 because you are listing something in the f.d.a. that isn't allowing generic competition. you can say the blame is with the patent office f those were not listed at the f.d.a. you would have generic alternatives, is that not correct? commissioner califf: my grandfather was a baptist minister. we'll take our share of blame here. it's a point of emphasis between us and the patent office now to try to get rid of frivolous patents which is what you are referring to. just to extend the time period which the company -- mr. khanna: would you say that in the case of copaxon where the company is asking for more

patents and multiple sclerosis patients are paying $50,000. or one for leukemia there could be some of those being frivolous? commissioner califf: as f.d.a. commissioner that decision really is an f.t.c. decision. i have personal opinions. mr. khanna: what's your personal opinion? commissioner califf: there are too many efforts made to extend patents. i want to -- mr. khanna: what about for astrazeneca and the inhalers. commissioner califf: i can't refer to a specific one. i will note that my mom got some extra life expectancy due to revalimid and i'm very familiar with what happened to the cost. mr. khanna: my question is what can we do in congress? this is what's frustrating people. i'm not tkpwhraeupl blaming you. i'm saying you have a system where you are listing these drugs. maybe you are saying your hands are tide. it's not wreug the -- bringing the costs down.

we keep get interesting the american people's perspective, how do we solve this? give me 10 seconds one more question. do you have a 10 second recommendation? commissioner califf: maybe the analogy worn out. we are the referees. it may be something where our staff has to get together with yours and the patent office and see if there is anything to be done to tighten up the law. mr. canon: the last -- mr. khanna: the last question i want to ask. i know when you were in the f.d.a. and afterwards you got consulting fees from merck, astrazeneca. i take you at your word there were ethics reviews and you said there were no ethical conflicts. one of the things i proposed is members of congress should not become lobbyists. would you commit today that after your service as f.d.a. chair you will not take any money as consulting fees from big pharma going forward? commissioner califf: i have a written record on this for two years. beyond that point we'll have to see. mr. khanna: why not make that

commitment so the american people have confidence you won't take -- can you make plenty of money at google or somewhere else? commissioner califf: i'm not looking to make money. i'm looking to distribute to the development of effective -- mr. khanna: why not say you won't take it after regulating it? make that commitment today. commissioner califf: i certainly have made the commitment for a period of time. i can't speak for the rest of my life. mr. khanna: i think you should. commissioner califf: i appreciate your opinion. chair comber: the chair recognizes mr. fallon from texas for five minutes. mr. fallon: i think we have bipartisan agreement with representative cana. i would love to co-author any bills you have for preventing members of congress from becoming lobbyists. good government. thank you for that. thank you, mr. chairman. i'm here, commissioner, not so much as a member of congress but a parent. i want to visit with you on a few things. particularly i have two teenage boys, 17 and 14. i see the teenage vaping

skyrocketing. i think that's an entry to really knee farrous habits -- nefarious habits moving forward. i'm concerned about the illegal chinese vapes and the f.d.a.'s role in contributing to this proliferation we see across the country. the tobacco control act of 2009 created premarket review process allowing for new tobacco products to enter the market. yet as myself and nearly 60 of my colleagues pointed out in a letter we sent to the president last month, a letter led by my good friend, congressman richard hudson, despite the f.d.a.'s receiving over 26 million smoke-free applications since this law, the f.d.a. has authorized fewer than 50 product applications with less than 10 being commercially available. during this time, however, they have authorized thousands of combustible cigarette product applications. january of 2024, there were only 23 authorized e-cigarette

products and all by three manufacturers. the f.d.a.'s inability to process the pmtas in a timely manner resulted in a proliferation of illegal chinese vapes flooding the market over the country to meet the consumer demand. often in flavors i'm sure you hopefully agree are horrific in so much as they appeal to kids. peach, mango, watermelon. which is a flavor currently offered by e.b. create. a popular brand formerly known as elfbar. a chinese company whose vaeps are illegally here. easily purchased at local stores. in fact, local shops, smoke shop over in virginia, this picture was taken two days ago, and you can see the -- yellow up there, those are all displayed. they are illegal chinese vapes along the wall. when i speak about hypotheticals

and back alley deals this is flavored noncompliance. by the inaction of the f.d.a. what we see is almost a prohibition on legal products with unregulated and legal products rushing in to meet the demand. by further weak action on enforcement, u.s. stores have no concerns about openly selling the products all over the place. commissioner, by law how long does the f.d.a. have to review m -- pmtas and take action. commissioner califf: i believe it's 180 is the legal. mr. fallon: how long does it take? commissioner califf: it's hard to calculate actual number. there are 26 point something million applications. some still outstanding. we are not meeting the 180-daytimeline. it's getting better as we are plowing through. 99% complete. which still leaves hundreds of thousands to go.

mr. fallon: the interest stakeholders have told us it's three years. is that feasible? commissioner califf: remember the history. when i was commissioner in 2016 right when vaping was starting. it went immediately to millions of products. there were laws in between. and it's the case there was such a flood of products it could be if you went back three or four years ago you would say, ok, three years until now. if you look at applications coming in now, it's much shorter than that. mr. fallon: the f.d.a.'s website shows the approved pmt's for 2023 took roughly 2 1/2, three years. commissioner califf: there was an effect that had to be dealt with. as one of your representatives pointed out. millions were taken care of by getting rid of the ones that didn't have useful data in them. mr. fallon: i think it would be behoover you to have a regulatory framework in place and warning letters are one thing.

how many seizures have we had at retail shops across the country? commissioner califf: we have only had a few seizures. we have had 32,100 civil money penalties. those are ramping up considerably as we go. i think you know seizures require a whole different order of magnitude of legal work both before and after. mr. fallon: how do we -- these are all over the place what do you think the f.d.a. can do to mitigate this? commissioner califf: given the fact that there is a vape shop in almost every neighborhood, it would take a lot more people to do what you are saying of clearing the shelves. we have an action plan. it's going to get better and better. as i have already said if user fees were paid by the vaping industry, that would be about $100 million. we could hire a lot of people and spend more time out there in

the shops. mr. fallon: i'm not trying to suggest every illegal chinese vape will be taken from the shelves. you know as well as i that when you have -- you can set examples and make examples. word gets out if you have these products you are going to get heavily fined. and seize them as well. i yield back. chair comber: the chair recognizes mr. m mfume from maryland. mr. fume may: i thank you and mr. raskin for convening this hearing. before i go into my observations, dr. califf, let me go back to something that the ranking member said earlier i don't want to get lost in all of this. that is that maybe what we ought to be doing in addition to this is trying to find a way to create more regulatory pathways. giving the f.d.a. the ability to do many of the things that you said you could not do here today. dr. califf, i'm deeply concerned about overprescribing of a.d.h.

medications. particularly ritalin and concerter as it relates to kids in poor neighborhoods. as it means of dealing with their, quote, hyperactivity in school. and that so many studies have shown that whether they are poor black, poor white, poor latino this overprescription seems to take place. i'm not a conspiracy theorist, i don't think hump at this, dump at this fell. i think he was pushed. so moving under that premise i think that unless we do have greater regulations over the overprescribing of these medications, it will continue. let me just flip that around to the other side. aim he also deeply concerned about children who are unable to focus on things. and are given these medications and where all the protocols have been followed. i'm concerned about that because in many instances those drugs,

unfortunately, have been part of the shortages. i'm concerned about cancer patients who are forced to delay treatment, as you know, because many of the required medications are out of stock. those are just a couple of the things that i'm hearing from my constituents in baltimore on a regular basis. i know the supply chains were disrupted during covid. and that there have been intermittent and sometimes not intermittent drug shortages occurring throughout the u.s. i would be less than honest if i didn't just tell you from my perch some of the things that i hear. i recognize you don't carry a magic wand in your back pocket. the only thing you can do is help guide us, listen to us, and suggest to us ways that we can help you. the f.d.a. serves as an important regulator to say the least. it is well positioned to assess potential supply chain

disruptions. can you tell us and this committee anti-people around the country -- and the people around the country who may be watching these proceedings how is the f.d.a. working now currently with manufacturers to mitigate the ongoing drug shortages? and if those manufacturers, in your opinion, been transparent with the f.d.a. about potential shortages andle real root causes of those shortages? commissioner califf: thank you for that. first of all just a comment you made about the underprescribing and overprescribing. i think it exemplifies a major problem we have in the intersection of the responsibilities of the f.d.a. and the practice of medicine. there is no doubt that people that need these drugs are not getting them. and people that don't need them are getting them. that equilibrium is not set by the f.d.a i'm also a physician. it's a clinical quality issue

that we need to work on. we are trying to help as best we can with that. your main question about the manufacturers, we work every day with the manufacturers. they are required to give us certain information. frankly they have resisted us -- giving us some of the crucial information that we really need. when there is an impending shortage, we are finding they are very cooperative to work together to try to fix it. but it would be better if we had all the data we needed to put together predictive algorithm that is would allow us to intervene preemptively much, much earlier and prevent the shortage. we have a list that you all have a copy of that lists areas where the correct information would make a difference. i also want to point out while there is a shortage of the stimulus for adhd, the biggest shortages are occurring in inexpensive generic drugs. the less expensive the drug the more likelihood of shortage because of the way the market is

not succeeding and rewarding high quality manufacturing. that's a point we really need to address over the next few years. mr. mfume: any guess on your part as to what factors affect nongeneric drug shortages? commissioner califf: for nongeneric drug shortages there are really own two major types because if it's not generic drug as we talk. in general the manufacturer is making a handsome profit once the product is on the market. so they are pretty good at figuring out how to make it. the exception is ozempic or the weight loss drugs where the demand is so high they haven't been able to keep up. mr. mfume: i yield back. chair comber: the chair recognizes mr. biggs from arizona for five minutes. mr. biggs: thank you, commissioner, for being here today. the university of arizona has been engaged in research that would advance pain and addiction research to help combat the opioid crisis. they are looking for ways to

expedite known drug candidates through the phase two, phase three trials to take nonaddictive pain relief medications to the market. u of a has informed me they have found if they can repurpose clinically available medications that are proven to be nonaddictive and also shown to be effective for treating different types of chronic pain, they think they are ready to go forward in these trials. they also report that there is a need to repurpose some of the medications specific to sex differences. because pain is differentiated based on sex. that would have an impact on how they develop this drug. the question is, during the covid era, f.d.a. was able to expedite clinical trials that u of a tells me they are struggl obtain approval for phase two and phase three clinical trials on something that could alleviate chronic pain and help reduce the risk of

opioid addiction that we see so rampant in society today. my question is, could this be a statutory problem? a regulatory problem? a resource problem? what might -- we be looking at? i recognize i'm giving a specific example but hoping you can give us some information. commissioner califf: the way it works at f.d.a. and the drugs, users fees are paid. we have statutory or agreed upon passed by congress every five years with the user fees. timelines, we are meeting those timelines. which are agreed to between the industry, the f.d.a., and put into law by your passing the law. i'm not aware of the particular circumstance you are giving. there is a thing that we say at f.d.a., in god we trust, all others must bring data. i have to know the specific data coming from the university of

arizona to know if there may be some issue that's causing a back and forth that wouldn't fall within the usual timeline. when that happens, it's very much noted that that's the case. mr. biggs: we would love the opportunity to present you with additional information. whatever we need to find out what might be the hitch in the get along w that i yield to the chairman. chair comber: thank you are for yielding. f.d.a.'s responsibility to ensure that the safety and efficacy of all drugs marketed and sold to the united states regardless of where the drugs are manufactured. yet the number of inspections conducted annually has been declining since 2013. at the same time, chinese and indian manufacturers have received the most f.d.a. warning letters by far. these violations include contaminated medicines, nonsterile manufacturing, and falsified data. how is the f.d.a. working to keep foreign manufacturers accountable? commissioner califf: i

appreciate that question. as i have already established we are doing a major reorganization because i agree with you that we need to pick up the pace of the inspections that we are doing. again as i have already said, the first line of defense are the manufacturers themselves of the here's where modernization of our data systems is important. the more we can keep up with what's going on, not just in u.s. facilities but around the world, the better we are able to target our inspections and have the frequency that's needed to keep the manufacturer in shape. one of the big areas we are working on is india where we completely redone our inspectional system and i have personally gone to india to meet with the indian government to work on the relationships so that the inspections can proceed. i believe they are acting in good faith in india right now is one example. think of it as a later of data and information that should be

constantly coming in now that all manufacturing is digitized. then the human side where the inspector actually shows up, the investigator, in the facility, those are being increased. it's been a major point of emphasis in our re--- reorganization. chair comber: there is a lot of bipartisan agreement on controversial issues in this congress. one thing i think there is overwhelming bipartisan agreement on is the fact that we need to have more domestic manufacturing of our pharmaceuticals. what in your medical opinion as commissioner of f.d.a., what can we do in congress to encourage an environment where all of our essential -- much more at the very least of our essential pharmaceutical production is manufactured in the united states? commissioner califf: one of your colleagues pointed out through the method of asking the question, i don't think it's a

big issue for innovator drugs. that industry doesn't experience much in the way of shortage. for this generic area, it's an area where we do need -- chair comber: it's a national security issue. commissioner califf: absolutely. when the raw material is coming from china it's an issue we need to take seriously. as you know f.d.a. doesn't deal with the prices and the market per se. i would refer you to the h.h.s. why paper that just came out with input from us. we need to create an economic market situation where the price is fair so that the manufacturer can produce a product, but also invest in the technology of manufacturing. and can be done using american labor, which is more expensive than labor in other countries. i also say, i'm not talking about 100% reshoring. i don't think we need that. we need enough after footprint in the u.s. and in nearby countries that we are assured that if something goes wrong anywhere in the world, we keep

this up. 95% of our prescriptions are now generic. chair comber: my time has expired. i recognize ms. bush from missouri for five minutes. ms. bush: thank you, mr. chairman. st. louis and i are here today, dr. califf, to first thank you for the work that the f.d.a. has done to eliminate cumbersome restrictions on mifepristone. one of two drugs used for medication abortion. as ranking member raskin mentioned at the top of the hearing, pheuf preus stone is subject to a risk evaluation and mitigation strategy. during the peak of covid-19 the f.d.a. suspended enforcement of the rims requirement that mifepristone be dispensed in person. due to the success of this trial run, we know that in january, 2023, the f.d.a. permanently updated the strategy to remove the in person dispensing requirement. this has proven that the in-person dispensing requirement was never actually medically necessary. i have a bill called the

protecting access to medication abortion act which would assure that mifepristone, one, does not have an in-person dispensing requirement. two, allows patients to sack ses prescriptions for mifepristone via telehealth. and authorizes all pharmacies certified to dispense mifepristone to patients to do so via mail. thank you to the f.d.a. for your commitment to your evidence-based care. that serves patients and not politicians. next i want to turn to sickle cell. a disease that affects approximately 100,000 people across our country. the majority of whom are black people. and about 2,000 people across my district. in fact, according to the c.d.c. one out of every 365 black children in the united states are born with sickle cell disease. it suts at lease 20 years from that all members may have five legislative days to revise and extend their remarks expectiancy. as a nurse i streeted people with this disease. patients experience totalizing pain. and it is debilitating. this illness completely takes

over your life and it is heartwrenching and we don't speak enough about it. last year the f.d.a. issued a groundbreaking approval of the first gene therapy to treat sickle cell disease. this new technology is the first genetic -- first time genetic editing has been used to treat any disease. as a result patients who face excruciating pain and even death from sickle cell will now be able to manage this life threatening condition. for many who may have been unable to hold steady employment, spend time with friends and family, or otherwise participate in everyday life because of this illness, this is life altering and sustaining. this technology would be impossible without the diligent and science driven work of the f.d.a dr. califf, what did the f.d.a. consider when determining the new sickle cell treatment, determining it is safe and effective? commissioner califf: as i believe you probably know there

are actually two treatments approved. one using gene editing per se. and another using a viral investigator. in both -- vector. in both cases human clinical trials are done taking sickle cell patients as you know being a nurse people with sickle cell disease, even though their genetic issue is essentially the same, the same area of the human genome, the manifestation of the disease is quite different. what was done in these trials were to take people who were having the worst outcomes, many attacks of painful crises, and then doing the gene effort. then following them after and showing that those crises abated almost completely. it was quite remarkable. in a small group of patients, so there is a lot yet to learn. it was important to give access to that treatment to those who

would benefit. ms. bush: ok. is there potential for this new treatment to be used to treat other genetic diseases? commissioner califf: very exciting. i alluded to it in my opening comments. i was around for the human genome project. people for decades said where's the beef? we put all this money into -- 3.2 billion base pairs. now we are here because thanks to the science we can go in with molecular scissors and snip out the gene that's causing the problem and put in a new one or snip out the gene that's causing the problem if we don't need to put in a new one. there are 10,000 rare diseases with no treatment right now. you are talking about parents of children who have terrible outcomes. this is such a revolution in terms of therapeutics we are making major changes within the f.d.a it's got to go further than that. you are aware that the cost of

these treatments is quite high. i think there is going to be a lot for you and congress to work with the administration on here to anything out -- to figure out if you are parent after child with a rare disease now, there is hope that within a few years we could have an effective treatment. if we have hundreds to thousands of effective treatments that the environment in which it's done is going to look different than it does right now. i hope that was helpful. ms. bush: yes. chairman, can i -- thank you. one last question. how can we assure people who require these genetic therapies aren't priced out? like you started to allude to. commissioner califf: i can take the easy out and say it's not -- f.d.a. commissioner on a hearing about f.d.a. it's definitely not in our remit. i can assure you there are many discussions going on across h.h.s. where, as you know, for example, on sickle cell disease the majority of patients are on

medicaid. because their medical costs are so high and the difficulty with jobs in a case where you are sick a lot. we have to come up with new pricing schemes. i am as an academic a health policy person. i shouldn't opine on that here at this hearing. i would be glad to talk with you separately. ms. bush: thank you. i yield back. chair comber: the chair recognizes mr. higgins from louisiana for five minutes. mr. higgins: thank you for here. your authority is vast and your responsibility is great. and you are a gentleman of distinguished stature. i appreciate you being here today. you have to give serious answers to hard questions. and i do, indeed, have some hard questions to submit to you. i'll be submitting the more interesting questions in writing.

for the record. after the hearing. for legislative purpose i have a specific line of questioning regarding imported seafood. i'm going to be discussing with you. as a matter of background according to my research and investigations about 60% to 65% of seafood consumed in america is imported. and generally speaking given the limited resources that you have at your avail, you are able to superadvise the inspection -- super advise the inspection of about .1% of imported seafood, is that generally correct? commissioner califf: first by our account it's more than 65% of seafood. mr. higgins: this is the republican side. i'm being conservative. commissioner califf: ok. much as i described on the drug side just a few minutes ago, it

starts with a digital inspection. that is we have information about these facilities. mr. higgins: the shipper and owner. commissioner califf: as it comes in we use artificial intelligence now to look at the characteristics of the shipment to pick out. it's not just the small number you referred to out of overall. it's a high risk part of the import. mr. higgins: i appreciate that level of expertise. and of course the dynamics of illegal imports would include inspections beyond the biological and chemical realm. according to a september, 2017 g.a.o. report titled imported seafood safety, the f.d.a. and usda could strengthen efforts to persuade -- to prevent unsafe drug residues in imported

seafood. a whistleblower has come forward indicating that a company called choice canning, an indian shrimp exporter, has knowing shipped antibiotic contaminated shrimp to the united states. despite this, the f.d.a. data shows only 21 shrimp stafrpls from this company have been tested since 2003. just to put this in perspective. again, respectfully, sir, you have a massive job to do. and limited resources. i respect that. i want to help. this company, i'm referencing, choice canning company, a known violator, imported 24 million pounds of shrimp to the united states last year alone. basically imported sea forward is coming into our country. the billions and billions of pounds is very little of it is being actually inspected at the

laboratory level for biological and chemical contaminants. the reason we are not getting sick is because we cook the seafood. basically that's the reality. i would like to ask you, if you had some -- had legislation from this body that gave you teeth in your enforcement like the authority and the mechanisms to destroy shipments that had been found to be contaminated, would that power be helpful for f.d.a. enforcement of imported seafood that violates american standards for biological and keepical contaminants? commissioner califf: you asked the question in a specific way i'm reluctant to sayous yes. mr. higgins: you can say just yes. commissioner califf: in the general direction you are going, i would say in general, including this arena, the industries by and large fought our ability to do what you described. it's not just true in the area

that you mentioned. but in general i believe we would exercise our authorities responsibly and could more quickly take care. there is stuff which sits there for a long time given all the things we have to do in order to stop -- mr. higgins: roger that. my intention, i am going to close by saying my intention is to legislatively empower the f.d.a. to have very aggressive responses to shipments of contaminated seafood that interyou are our country. mr. chairman, i yield. commissioner califf: let me thank you for that. i'm a south carolinian. i think our shrimp is bert than yours. in any case there is nothing i like better to see a resurgence of the seafood industry. mr. higgins: i learned from a young man not to argue with a gentleman in a bow tie. chair comber: the chair recognizes ms. stansbury from new mexico for five minutes.

ms. stansbury: thank you, dr. califf, for being here today. it's wonderful to have you. i want to thank your staff for being here as well. i'm grateful for the opportunity to highlight the importance of science and science-based decisionmaking in this hearing and all that you are doing to protect the american people to ensure that we have access to medicines that work. that we have food that doesn't harm us. and to ensure that every american can get lifesaving care. and also for your work and the administration's support of our work this last congress to pass once in a generation legislation to expand access to health care. to invest in science and innovation. and of course, to expand access to prescription drugs for seniors. the f.d.a. is truly on the frontlines of that battle every single day. and we are really grateful for the work that you do. and i'll say on a personal note i have a family member who was formerly an f.d.a. employee. and you represent the best of

the best that our country has to offer. nowhere is this more important than in the realm of reproductive care where we have to continue to follow the science and ensure reproductive freedom, especially in the face of unprecedented attacks. as we have seen republicans in this body, in fact, in this room and across the country, have been working to ban abortion, first through donald trump's supreme court, which overturned roe vs. wade last summer, and then chipping away state by state to implement abortion bans, including where in arizona just this week the courts upheld a civil war era abortion ban. that's right. for folks that don't know this, this ban was put in place in 1864, before an end to slavery had been ratified by this body. before women could vote. and before arizona was even a

state. let's be clear. no judge, no politician, no person should be able to tell a woman, any woman in america or anywhere in the world, what she can do with her own body. and nowhere is this more important right now than in the united states supreme court which we are all watching very carefully in the wake of their hearing of oral arguments in a case which the f.d.a. has been involved since the last couple of years over mifepristone. dr. califf, i want to ask you a question if you could talk to us a little bit not only about the implications by the decisions of supreme court for women to access reproductive care through medicated abortion, but also what are the wider implications for f.d.a.'s ability to use science to approveedhat i

i will say that our -- we stand by our decisions. they are still in play today. and i'll do have concerns if judges start second-guessing f.d.a. decisions about what that means for the broader area of having a rational system of availability of medications and devices for the american public. ms. stansbury: the f.d.a.-approved mifepristone to be used as a totally appropriate medicaid medicated way of addressing issues around reproductive care. the producter implications are if judges start legislating from the bench on this kind of medicine, it could be anything. it could be cancer treatments. it could be any kind of

medication or intervention in your health. and i think the american people need to understand the implications of this case. the potential impacts for public health. and the ability for it to impact every american's opportunity to access lifesaving care. we appreciate your work. and i am personally thankful to be from a state, from new mexico, that has worked to protect reproductive care. but if the supreme court does overturn f.d.a.'s decision to approve that medication this summer, we could see a ban on medicated abortion across the united states, including in places like new mexico where it is protected. that is why this body has to urgently take action. that's why we have to defend the science. it's why we have to sit here and defend our agencies who are making sure that american women and all people have access to the care that they need. and it's why we have to do everything we can to defend our institutions. because the lives of our community is literally depend on

it. thank you. commissioner califf: comment if i may. everywhere i go in the world our system of drug development and decisionmaking is the envy of the rest of the world. they all want to be like us in that regard. i have already commented our use of generic drugs in public health is falling short now with our drop in life expectancy. the system that you described is one that's very important that we preserve in general. in addition to the topic you are specifically talking about. chair comber: the chair recognizes mr. perry from pennsylvania. mr. perry: thank you, mr. chairman. thank you dr. kay little. i want to talk to you about the world health organization -- commissioner califf: my name is called all kind of things -- mr. perry: califf. sorry. that was an incorrect pronunciation, that was plain wrong. i want to talk to you about this treaty. i think 1835-plus nations

including places like yemen, iran, iraq, afghanistan, cuba, haiti and some terms in that we haven't seen it. we haven't seen the 30-plus amendments. we are shooting in the dark here. i don't know that you know any more than any of the rest of it -- about it than we do. there was another draft just last month that created a multilateral system for sharing pathogens with pandemic potential. i already listed some of the commissioner califf: it commits each party, which would include us to promote timely access to evidence-based information on pandemics. and the aim there is to combat misinformation and disinformation, i guess, as you see it or as they see it.

my question is with the potential threat to u.s. korcht that a pandemic even exists and the prescribed remedies including lockdowns and maybe even medicating, would you commit before the committee today to pledge not to adopt policies included or pursuant to the treaty until such time and if such time as that treaty would be ratified by the united states senate? commissioner califf: i'm not sure how to answer that question given the complexity of what you said, but it's hard for me to imagine we would have to do something that is not a government policy. and you referred to the senate in particular. mr. perry: if the senate didn't ratify it wouldn't be a treaty

that we are signatories to. is there any intention on the f.d.a.'s part to institute any of the provisions within the treaty without the proper ratification from the united states senate? commissioner califf: i don't think that would fall within our purview and i don't know enough to make a commitment. i will comment that if we look at the avian flu situation, the knowledge of the structure of whatever the path again is turns out to be critical to come up with countermeasures to treat it. i hope we can work out a way and even for food safety or the imported food that we get, the genetic path again turns out to be really important. i get what you are saying. we have to do this carefully of whatever you do, but i hope we

don't get exposed to a new pandemic that we know nothing about the organism. mr. perry: people want to maintain their medical sovereignty that we all enjoy. the c.d.c. was involved in media companies taking down media social poaforts regarding misinformation and disinformation, terms that i think are loosely involved -- defined. but the f.d.a. has awarded several grants in the range of hundreds of thousands of dollars to places hike the university of maryland, college park, texas women's university regarding misinformation and disinformation. commissioner, has the f.d.a. taken down social media posts or any other topic regarding

misinformation or disinformation? commissioner califf: not tige. mr. perry: if the f.d.a. is granting organizations like the university of maryland or texas women's university to mitigate the spread of misinformation or disinformation, that's essentially subcontracting out that duty, you're saying the f.d.a. hasn't done it particularly, but have they done it incorrectly through subcontractors via the grant program? commissioner califf: i'm not aware of the particular contract you are talking about. throughout the entire history the f.d.a. makes a decision about a product and puts together the risks and benefits as to whether it should go into market and put into label and the label is transmitted to clinicians who work with the

patients to make decisions about what to do, the sovereignty that you refer to is tiply a doctor hitch patient. places of university of maryland has a first-rate medical center. they are intermediaries in the process of relaying useful information. if someone is saying something that is flatout wrong, how about the university of maryland, that's their business. mr. perry: when you found out they were wrong in the past coercing social media companies to take down posts that were found to be incorrectly done, where is the remedy is there an apology from the f.d.a. to these universities that have have been fast on the trigger and coerced and changed the narrative or changed behavior based on things that aren't true?

commissioner califf: far be it for me to apologize for the university. what the university does -- mr. perry: it is a reflection on the f.d.a. i yield. mr. comer: the chair representative brown from ohio. ms. brown: congressman pressley and i wrote to you urging an investigation into the link between chemical hair straighteners and uterine cancers. i surprise my gratitude for your rapid response and dedication to addressing this matter. i am pleased that f.d.a. has taken steps with the proposed rule to limit the use of harmful chemicals found in many hair straightening products. black woman experience discrimination our hair which

has led to widespread use of these products. plaque hair shouldn't restrict our ability to learn in school or advance in the workplace or hair care products come with health risks. as the f.d.a. finalizedes this rule, i look forward to ensure our consumer prowpghts remain safe. you are hard at work to protect americans in other ways. the administration and democrats continue to fight to protect and preserve women's reproductive rights. the f.d.a.'s landmark aprfl of over the counter birth control moves us to reproductive. and other attacks in reproductive health. women have the right -- women must have the right to control when, if and how to start a family. increased access to safe and

reliable contraception provides space for that decision to be made while putting control back in the hands of women. what have been the impacts so far of over the counter birth control hitting shelves across america? commissioner califf: we are in the early phase of it obvious. and there is a lot to work out when something goes commercially. the availability as more manufacturers come on the market given the precedent, we should see much more wide sail availability and people can use the products as indicated. ms. brown: one last issue is a disease affecting many in the black and brown community. one in eight plaque americans live with diabetes while in my district, the diabetes rate is

over 25%. over 1 in four. certain weight loss drugs and obesity, like type 2 diabetes. for many, these drugs are life changing and lifesaving. unfortunately, though, these medications are often too unaffordable and inaccessible who those who need it the most especially uninsured individuals. commissioner, how is the d.a. to make sure these drugs are getting to populations who need it the most? commissioner califf: there are special populations at much higher risk. rural people in general suffering greatly and one of the main reasons we are seeing this troublesome decline in life

expectancy. right now, despite the fact we are producing a majority of the innovations in medical products, we are almost in last place in terms of life expectancy and the disability and multiple chronic diseases that go along with it. our tools at f.d.a. are limited for what you described because we are limited by law in dealing with price or products when they come to market. this is a policy issue for all of the administration and for congress to consider. the one thing we do when we have a set of products like this that look so effective so far is working with the get more products on the market because the competition does bring the price down. what you are referring to is most unfortunate. there is a saying that it makes you feel bad in a way.

but it was in the atlantic during the pandemic and technological solutions. diseases seep in society's cracks and the problem is, here we have an effective treatment, who is getting it. the wealthy. who needs it the most, the people you described who may have lower income and are in the need. so this is a major policy problem. i'm sorry the f.d.a. is limited in what it can do but i can ensure that thinking hard about what it might do for this. ms. brown: i thank you for the work you are doing and i look forward to staying in good contact with you and i yield become. mr. comer: the chair recognizes mr. palmer from alabama for five minutes. mr. palmer: you said use of

c.b.d. especially long-term use and mentioned a couple of things that were problematic including harmful male reproductive system and concern for children during pregnancy. the f.d.a. is engaged in monitoring the use of krbd, is that correct? >> it doesn't fall into particular regulatory scheme that we have. we have had plenty from congress to study the problem from independent studies -- mr. palmer: i appreciate that, my question is should the f.d.a. be more involved in monitoring c.b.d. because it is becoming popular throughout the country? commissioner califf: we would like congress to establish a

regulatory process for c.b.d. mr. palmer: we talked about vaping and not going to get into that but i have major concerns of the products coming from china and i have concerns about the lethalitiy whether it is tobacco or marijuana and is that something that the f.d.a. is actively engaged in in monitoring? commissioner califf: to the extent that we can. as we discussed earlier today, the regulation of marijuana is another area where we would benefit from congress reaching agreement on a regulatory pathway that enables the prevention of harm being done. mr. palmer: i'm glad you brought that up, because i agree with you. this body in the 1990 owe that the they increased nicotine is

not the cancer that caused people. there are other things from inhaling the smoke. you have some of the same issues with marijuana. that there's tar and other things that are inguessed in the lungs. but the thing that concerns me about this as well is -- and this congress acted, i think effectively in dealing with the tobacco industry in the 1990's. we are not doing anything to my knowledge to regulate what is going on in the marijuana industry particularly modified products. and as i reminded my colleagues, t.h.c. content was about 2%. and now it's from 17% to 28%.

and that's the addictive part of marijuana that affects the frontal lobe and impacts judgment. what we are starting to see now again, it comes in different forms. you just don't smoke it but take it as a gummy, or as an oil. and what is happening, more and more children are coming in contact with it and there is a report from the national center for biotechnology and information that is found one of the medical publications that says in terms of addiction, 9% of those people who experiment with it become a difficulted. 17% of those as teenagers and detail users -- is that another area where the f.d.a. needs to

engage because we see more and more states legalizing this. it is not an d.e.a. problem but a consumer problem? commissioner califf: this is an area where harm reduction through a regulatory strategy is our best approach and we need more research on what the facts are. the tobacco industry was engaging in genetic manipulation going way back just through the medallion radiation of the plan and development of my takes that would lead to more and more nicotine in the product. and now we have chemicals that can imitate any of these in a highly efficient way to produce the effects you described. we are concerned and see a regulatory pathway and we talked

about we need a rule book and you guys write the rule book. we would like to see a rule book in this area. mr. palmer: i appreciate your answers and i yield back. mr. comer: we write a lot of rule books and the administration has trouble complying with the rules. but any way, the chair recognizes mr. frost from florida for five minutes. mr. frost: i'm deeply concerned about the avian flu impact. impacts birds and livestock and one person lost some swans. while it does seem clear that the avian flu is not currently able to spread among people, folks are wondering how safe

they are. commissioner, how is the f.d.a. in coordination with the department ofagriculture and c.d.c. ensuring that americans have access to reliable information regarding this? commissioner califf: it is an important information. avian flu has been around for a while but only recently it has now infected cattle and cattle and cows in multiple states. this is an all of government effort. there are zoom conferencees multiple days times a day regarding agriculture. but also, many other areas of government that have a stake in the game of interstate commerce and department of justice and issues that are related. so we are all working together. you should see frequent communications as we work

through this. the most recent episodes with the cows is a relatively new thing. we are starting with uncertainty and working our way through it. mr. frost: the government designed to prevent and severe illness and death from the flu. will this medication be effective against avian? commissioner califf: it is useful to know the genetic composition of the virus. if you hook at the composition of this virus, there is nothing in it that should confer resistance to the current antivirals we have stockpiled. we feel good about that. there is an illness, you have to emperically prove that it works. so fortunately right now, there is only one infected human that we know of.

it's not something we can task, but it looks good. mr. frost: another subject that is important to me are allergies. i'm a survivor of and fill attic shock. and make sure the other 20 million americans who are allergic to some. 93% contain an allergen and many contain lactose. does the f.d.a. have the power to require labeling for food allergens and dpleuten? commissioner califf: we do have the power. mr. frost: biden signed into law the faster act requiring h.h.s. to submit a government report on food allergies.

that report has not yet been submitted and frustrating to americans. does the report fall under the responsibility of the f.d.a. and would you provide an update on the status of it? commissioner califf: i'm not familiar with that particular report. but we are very that allergies in the u.s. are apparently growing and there is a great need to make sure we get this right. mr. frost: we would love to follow up on that and gave you a heads up on that question. i yield back. mr. comer: the gentleman yields. the chair recognizes the gentlelady from michigan, representative mclean. mrs. mcclain: when you assumed office, were you aware that a

manufacturer who made more than 40% of the country's infant formula was voluntary recalling all the baby formula it made at its plant? commissioner califf: i was very familiar. i didn't -- >> in the days and weeks that came after you assumed office, were you aware that there was a shortage of infant formula across the country? commissioner califf: first days and weeks there wasn't a shortage but i was aware of. mrs. mcclain: were you aware 10 states reached 90% of out of stock and nationwide 74% had no infant baby formula? commissioner califf: those numbers do not sound right to me but there was a the on of

stock. mrs. mcclain: could you say we were reaching crisis mode? commissioner califf: closest to crisis. mrs. mcclain: i would like to enter two internal exchanges first one dated february 4, 2022 and discussing infant supply issues and asking support from the white house to educate the public. the second on february 19, 2022 the f.d.a. officials were discussing the supply issue that were already happening. now despite these discussions within the f.d.a., media reports and the president was not aware of the problem. even though it was headlining in every news channel and every paper across the country for three months. my question is did the f.d.a. not raise concerns about the

potential shortage even before the recall? commissioner califf: there is a record that there is a supply disruption task force that was put up during the covid crisis that was used for this purpose. mrs. mcclain: it was elevated? commissioner califf: to the task force. mrs. mcclain: did the f.d.a. raise concerns about a potential shortage even before the recall, yes or no? commissioner califf: i can't speak before the recall but about the time. mrs. mcclain: the f.d.a. did, in fact, raise the issue to at least nine different white house officials and president biden took no action. so i would like to enter an email between the f.d.a. and nine white house staff including members of the national security council, domestic policy council and special assistant to the president for public health. this email dated february 17 of

2022 which is the day of the voling unitary recall shows the white house in communication with the f.d.a. mr. chairman, i would like to enter another email into the record, email dated february 20 of 2022 just three days after the voluntary recall which shows the f.d.a. chief of staff already raising concerns about an infant formula shortage and raising concerns with the white house. why did it take three months for president biden to invoke the act? commissioner califf: i can't speak for president biden. i will note as i have already said, i don't have emails that you are referring to. mrs. mcclain: i'll get them to you in a timely fashion.

commissioner califf: this evolved over time and when the e.p.a. should have been brought in is a matter of discussion. mrs. mcclain: that's your answer. your office has been in communication with nine white house staffers, either the f.d.a. didn't tell him or he didn't act, which is it? commissioner califf: you have the email. mrs. mcclain: you make about 200 grand and make in charge and when you know what hits the fans -- it's my time. when asking b.p. handling of this is unbelievable. you don't have an answer. i would love to have an answer. commissioner califf: you are overestimating my salary. mrs. mcclain: 191,000. it cost millions of dollars to manufacturers have products pending at your facilities for

years. i know we have talked about this and you know the concern of the illegal products coming over from china. when do you anticipate getting some results from these american companies that have been waiting for over four years on their tobacco products? commissioner califf: as we have already discussed, 99% done with 27 million applications. we have 1% left to go. these are big decisions and going to be rolling out. we expect to be caught up with the largest from the american pediatric group that follows this by the end of this year. mrs. mcclain: i yield time. mr. comer: the chair recognizes representative lee from pennsylvania.

ms. lee: the f.d.a. doesn't hold this responsibility. the agency does not have the resources to single handedly ensure the integrity of every product of every food and device manufacturer. the priest sector has to ensure their products are safe and reporting has covered a pittsburgh based company and one of the p received complaints of c pan machines and recall being the largest. not om did they receive complaints from hospitals, patients and providers but its internal evaluations indicated their machines were toxic and the company withheld this foyer from the f.d.a. and the public. they continued to sell these hazardous machines and enabling

their stock prices to soar and the most immediately vulnerable are infants, our seniors and veterans suffer. in pennsylvania more than 700 personal injury lawsuits against the company due to irreparable harm its devices caused patients. one of the most egregious examples when companies don't take their responsibility. covid vaccines to dangerous levels in children's apple sauce products we have seen the private sector fall short. what is the private sector's responsibility that medical devices brought to the market are safe and effective? commissioner califf: as we have discussed, the primary first line responsibility is we are a regulated industry. this is a situation where we over's the industry but the responsibility has to produce

safe and products whether device, drug or food. ms. lee: what enforcement action does the f.d.a. need and deter future wrongdoings? commissioner califf: this has come up in every commodity and better for public health if we had direct recall capabilities across the spectrum of products that we regulate when we find problems such as you're referring to. i would like to see a bull king up of our capabilities. every american has an electronic health record and when we find out about these problems earlier than we currently are and make sure that the manufacturers report in a timely fashion when they do get problems that they are aware of.

ms. lee: over the years, f.d.a. has promised to overhaul dangerous medical devices. what progress has f.d.a. made towards those goals? commissioner califf: this has worked in my academic life for 30 years. everyone has an electronic health record and it is digitially captured now. we have multiple blocks in the system that keep us putting the data down as best we can. we are dependent on voluntary registries and health systems pitches in. there is a lot of discussion within n.i.h. and other part of h.h.h.s. having better pooling capabilities and we have a model where it is happening in israel where 100% of the population has

real-time accessibility to defect problems. but to find advantages. sometimes there are surprises where something works better than expected. but right now we don't know about it in real-time. ms. brown: i am not going to get through this next question and i yield back. mr. comer: the chair recognizes mr. burchett for five minutes. mr. burchett: i appreciate you doing this without a bathroom break. i have a question about the farm bill. 2018 farm bill, and transportation of products. since 2018, what regulations have the f.d.a. put in place. we have a law from you all hemp

as less than 3% t.h.c. you have given us money to study the problem and our conclusion. they are not safe enough to be called a diet tear supplement or food. we asked congress to put together a regulatory process so the products are labeled and identified and in cases gummy bears packaged for children there is a way for us to take action. mr. burchett: outside groups request the f.d.a. regulate hemp products? >> multicitizens' petitions. the requests have been to regulate them as dietary supplement because of liver

enzymes and other problems that we believe make them unsafe as supplements. but they could be made available if congress thinks that is the right thing to do. mr. burchett: are you an m.d.? >> board certified cardiologist, 35 years of practicing, sadly not practicing right now. mr. burchett: you would question whether we have a heart if you are a cardiologist. commissioner califf: the heart and brain are two different things. mr. burchett: let the record reflect that our commissioner is punch struck for being up here for so long. i am concerned about hemp. and i'll tell you why. and hemp, my daddy fought in the

second world war and i have seen. help us grow hemp to save the world. and it's a cousin of marijuana and doesn't have the t.h.c. level and we pass this thing in the farm bill and these folks that want to grow hemp, they say we have the greatest thing in the world. i have a little farm. i checked into growing hemp. not going to make me a fortune but i have to get a fingerprint to do it. the big boys from the cotton industry will be marching up to my office, but they wrote these regulations. they don't want hemp. and you can watch the videos, these people say it's not the miracle they claim it is. it is a huge labor factor and ticks me off that these folks have been fed this bill of goods and it's just not happening.

it's not happening like it should and i'm wondering and your office had any meetings with the cotton officials in which hemp was mentioned? commissioner califf: i'm not meetings with the cotton industry. mr. burchett: besides the fact not ingesting it. that's another problem with the product. it goes to two separate gaps. -- i think that is by design. so it keeps it more complicated. are you aware in the first two years of the biden station that the value of hemp production decreased by 71% snf. commissioner califf: no. mr. burchett: i'll get away from the hemp thing. the center for tobacco products i feel like they've continued to

not tell the truth in some cases to the american people. and tell us vaping is more harmful than cigarettes, yet -- dr. rigott i-con concluded u.s. health professionals should reconsider the position on e-cigarettes. the burden of tobacco-related dishe ease are too big for e-cigarettes to be ignored. you get where i'm going. is it more harmful than cigarettes if it is not abused? commissioner califf: combustible tobacco kills people. i was in the u.k. because we are having -- i went to oxford where the british doctor study, doctors who smoked died 10 years

earlier. you would be harmed in the residue what's in vaping. and thinking of what is going into your lungs, it is pretty horrifying. but it's much less toxic in terms of all the things that cause cancer and heart disease. the vaping than the combustible tobacco. if you have someone using combustible tobacco, they are a lot better off if they are vaping at least by those criteria. there is no question, there is no benefit of vaping other than it helps you get off the combustible product. mr. burchett: it will kill you. i went way over. thank you, guys.

mr. comer: the chair recognizes mr. garcia. mr. garcia: i was going to talk about a different topic but clarify some of the truly insane attacks on vaccines and just what happened during the pandemic tay we heard about earlier today which i found to be wild. i want to reiterate, we lost 1.3 million american lives. in my city, we lost 1300 lives in the city of long beach. with of the folks we lost would have lived if they had access to the vaccine. we know that for a fact and we know the success of vaccines and how effective they have been. what is concerning, early childhood vaccinations are reaching lows and other diseases

like measles that we are now not addressing because all of this vaccine denial not just happening across this country but here in this congress and chamber. vaccines outside of what happened in covid-19 is going to cause this country great harm. earlier today we folks on the other side attack vaccines with in my opinion, conspiracy theories and with treatment that are effective and shown not to work. this isn't a matter of personal choice. there are million coulds of people who don't have a choice because they might be too young or underlying health conditions. america eye high vaccination rates has helped our country that the f.d.a. has been so involved with and concerning that our vaccine process is being attacked. i want to note that there has

been comments made over and over again about vaccines and causing cancer or miscarriages or the covid vaccine has no effect on healthy people are all false. you know this and your team knows this and reiterate that for the public. what i did want to say and have less time to do so, but i want to transition and thank you and your team what you are doing to listen to the lgbtq community. myself, as an openly gay person, you allowing gay men to be a part of the solution when it comes to health and blood donations, when it comes to other forms of surgats f.d.a. has stepped as it relates to

lgbtq and gay men being able to donate blood. there was an emergency where my blood was needed and we would have that same right and thanks to all of you. in the time i have remaining could you describe the f.d.a.'s draft proposal on how this helps advance equality and donor pool as it relates to the recent changes you all are making? commissioner califf: i appreciate your comments. on the vaccines, i want to point out, all medical interventions have risks as well as benefits. if you want to be alive and not be in an intensive care unit, get vaccinated. some people do have side effects because it is important to take care of those. the benefits far outweigh the

risker. people have raised this issue about donation for many years and a questionnaire about behavior can do much better than the time-based thing related to the lgbtq community. we are well along on that now and looks like it's going to work and consistent with what other countries are doing. we are glad to come to this conclusion. mr. garcia: i yield back. mr. comer: the chair recognize mr. fry from south carolina. mr. fry: harm reduction is a pillar in the tobacco control act. the strategic plan embraced that harm reduction with the former f.d.a. commissioner successfully implementing harm reduction could dwarf impacts on our

public health. the centers for soap seems to have abandoned harm reduction as a principal by refusing to authorize other tobacco products that have been pending before your agency for years. you are not providing options for american smokers. a recent study that every e-cigarette that goes unsold due to flavor restrichs, and found that e-cigarette flavor restrictions yielded 20% increases in sales disproportionately used by underaged smokers. why has the f.d.a. authorized 900 new cigarettes? commissioner califf: we haven't

aband -- abandoned the preliminary. it is the responsibility to produce the data set that shows the benefits of combustible exceeds the risk due to getting teenagers addicted. vaping products get people addicted to nicotine if they are a new user. we have to raise that to the benefit of adults using combustible tobacco. there are 23 products that have met that standard and other companies are welcome to produce the data showing they meet that public health standard. mr. fry: do you believe in the continue you umh of risks and adult smokers to go to smoke-free alternatives? commissioner califf: there is not a yes or no answer.

for adults is to stop using tobacco products all together. second best would be to switch a vape. but the very best would be as we already discussed, if you look at the residue from vaping relative to no use of any tobacco product, it raises a number of issues. mr. fry: the concern i have and concern that many people share, there seems to be abandonment not only intent of a directive that we are going to pursue harm reduction as an actual strategy and 900 cigarettes approved and handful of vaping products that is difficult veering ent to what congress has outlined for your agency. would you gee? >> i would have to go back and look at that. we have not abandoned the idea that the companies show it can successfully transition people

from combustible tobacco to vaping which does not increase the risk of teenagers getting addicted to nicotine and then being switching. mr. fry: would you consider that to be a harm reduction product? >> we discussed this earlier. the term harm reduction tends to be used by industry. if there is a product that could cause someone to stop using combustible and not get teenagers addicted to nicotine that is a benefit. mr. fry: there seems to be a hefty backlog in the agency. how are you utilizing your work force to innovate the f.d.a. and what type of metrics to ensure you are being protective not only for companies that go

before you or for the american people? commissioner califf: there was a big backlog and we now cleared 99% of the backlog. when applications come in, we keep track of where which are and as we are employing better technology and we are just going through some organizational changes, you are welcome to read the report we chitioned. we want to meet the time -- commissioned. we want to do it as fast as you can. mr. fry: i yield back. corm corm the chair -- mr. comer: the chair recognizes ms. pressley from massachusetts. ms. pressley: let me acknowledge and thank you for your responsiveness and swift action on my outreach to you regarding

chemical hair relaxers and the shortage of children's tylenol and motrin and i appreciate your efforts in that regard. and finally for the purposes of questioning, reproductive justice. last year, the f.d.a. took steps to protect medication abortion access by allowing abortion pills to be prescribed by telehealth. medication abortions accounted for 63 frs of all abortions performed in the united states. if mifepristone is pulled, access to routine medical care would be jeopardize dollars for people across the country as part of their draconian unpopular goal for a national abortion ban, forced birth, which many will result in forced

deaths, republicans try to on block access to on medication like mifepristone by spreading baseless conspiracy theories. the fake news is rampant. i have a teenaged daughter and we two truths and a lie. we are going to do a variation of that. i want to clarify some of the disinformation by playing a game called fact or fiction. i'll say a statement and say one word, fact or fiction. let's start with this, fact or fiction, the f.d.a. conducted a rigorous review and extensive research on mifepristone correct that's a fact. mifepristone has been on the market for 24 years and more than 100 studies have affirmed its safety since. fact or fiction. judges know better than health

officials if abortion is safe. commissioner califf: supreme court is currently adjudicating a case that involves. but i'm on record and so are all of us, it would be bad for the entire system of drug development in availability of medications in the united states if judges began overruling as a matter of routine. ms. pressley: that's fiction, the f.d.a. not the courts derls the safety of drugs. fact or fiction, mifepristone as a form of abortion is safe and effective? commissioner califf: fact. ms. pressley: less than 1% of patients experience side effects posing fewer risks even than advil or tylenol. it is safe, effective and form

of health care that is made necessary and safe across the nation. this may be a game for today's hearing, but i have no interest in playing games with people's lives and this is gravely serious. pregnancy and childbirth can be life threatening. now i know this is a shock to the far right extremists old white men making these decisions, but there are hundreds of reasons why someone might want or terminate a pregnancy and policy makers and judges should not be the ones making decisions for them. if republicans and antiabortion extremists have their way, access to mifepristone will be cut even in my district where abortion care is legally protected. since i have been elected to congress i have been proud to

leave the task force under our pro-choice caucus allowing mifepristone access. and abortion is a fundamental human right and i urge my colleagues to do the same. thank you. and i yield. mr. comer: chair recognizes mr. burlison. mr. burlison: you made an appearance on cnn and claims that the leading cause of death in united states is quote, misinformation. do you recall being on that interview? commissioner califf: right. mr. burlison: you went on to say that in covid you need to get vaccinated that the reliable truthful messages are not

getting across and washed out by information which is leading people to make bad choices. draw your attention to a tweet that i toe you are familiar with. you are not a horse, you are not a cow, seriously yall, stop it. another sarcastic tweet read hold your horses, it may be trending but isn't authorized or approved to treat covid-19. the f.d.a. put out these messages in 2021 and made similar posts to discourage people from using a drug to treat covid. the f.d.a. was sued by a thumb of doctors who claimed you were practicing medicine as an organization as part of that setment you were forced to delete these, is that correct?

commissioner califf: that's correct. mr. burlison: the f.d.a. is not a physician and tweet-sized doses of medical advice is beyond your statutory authority, is that correct? commissioner califf: that's what the court said. mr. burlison: claiming that it is horse medicine would you not agree that is the exact definition of misinformation? commissioner califf: i would not agree with that. there are trials showing no benefit. mr. burlison: you knew that in 2021 you didn't know that in 2021. i'll ask the question. even to this day, you have to correct misinformation about the drug because you created a narrative that the -- let me ask this. it won the nob emp l prize?

commissioner califf: for the treatment of worms. mr. burlison: in humans. and next to penicillin and aspirin and considered as one of the wonder drugs and its effectiveness in humans, correct. commissioner califf: it is a medicine for animals also. both are valid uses. mr. burlison: at the end of the day you created in my opinion and i think it's obvious because you are still having to correct people if you think that a form of treatment that has been used how many times would you say historically that it has been used in medical treatment? commissioner califf: it's been used for worms. mr. burlison: been administered in humans billions of times over the last # 30 years, correct?

commissioner califf: again, for the treatment of worms. mr. burlison: let me ask this, you think that tweets like this garner correct to an organization. i would think that my teenage daughters might write. do you think that garners credibility? commissioner califf: i wasn't at the f.d.a. when the tweet was put out. mr. burlison: i am glad that the courts told you to remove these tweets because it is snarky and demeaning to the american people and to people i believe in my district. mr. burlison: i yield the rest of my time. mr. comer: try to get a quick question in here, commissioner. you mentioned talking about

c.b.d. oil that is nont.h.c. or .3 or less. you mentioned that you didn't think the f.d.a. could approve that? is that the f.d.a.'s position because there are a lot of people in the industry in the hemp drive c.b.d. industry that believe that c.b.d. throb treated as neutral ceutical. commissioner califf: number of citizens' petitions that have that plef but the research shows elevation of liver enzymes which are very concerning that if people take this over time could lead to liver transplants. mr. comer: i have seen this in kentucky with c.b.d.

manufacturers. there is a big difference. because it is the wild west, the f.d.a. will regulate this product, there are companies with labs that would be as good as anything that merck and people operate out of the garage people operate out of the garage because it's the wild west and the f.d.a. won't regulate these. it's like somebody offering something out of their house. mr. califf: that's where a referee needs a rule book that says here are the rules and you write the rules so we would really like it if --

>> the chair recognizes ms. crockett from texas for five minutes. ms. crockett: thank you for being here. you're a brave man. i don't know who would want to sign up for your job, especially in a time in which it seems like we don't believe in science, or we don't know what data is or we don't just ignore it, i'm not really sure. i don't know how long you were asked about i'veer hechten -- ivermectin. you would be a great witness in court. you refused to answer the way he wanted to which would be putting out misinformation because i do want to do a quick level fit on something and don't know how we continue to come back to this. but let me just ask you a few questions. was covid-19 real? dr. califf: yes, i had it myself

twice -- once or twice. ms. crockett: did people die? dr. califf: in the u.s. alone was a million people and was the top three causes of death for many months. i was an intensive care unit doctor. when i came to the f.d.a., i stopped practicing but my friends in i.c.u.'s were overwhelmed. hospitals had to have trucks backing up to the hospital because there wasn't enough room for all the dead people. ms. crockett: and did vaccines save lives? dr. califf: thanks for asking that again. people up to date on their vaccines have a significantly lower risk of being dead or admitted to a intensive care unit compared to those who were not up to date on the vaccine and worse of all people not vaccinated at all. that's on an individual level. if you look at the counties, those with higher vaccination

rates have lower death rates. if you look at countries, they have the same relationships. the vaccines have been highly effective, not perfect but highly effective. ms. crockett: i know there's no perfection, certainly not in this chamber. as a result of and ad administration that believes in status or data, and arfa stands for advanced research projects for agency and health. my district luckily was the recipient of a arpa-h customer experience centers and i'm so excited because this means as we are looking at trials, as we're looking at diversifying them, we will have a great opportunity right there in texas. it is a huge investment in science to make sure that we can save lives. and when the next pandemic arrives, we actually will be prepared and have science so we can stay on top of this because

the last time i checked, and doctor, correct me if i'm wrong, having a leader suggest that we should inject bleach, are you aware of anyone being cured of covid-19 because they injected bleach into their body? dr. califf: i'm unaware of any such thing. if i might comment in general, this is related to ivermectin. i can in with a heart attack and we tried a hundred different things for a heart attack and only a couple things worked and others didn't. the only way we knew what worked we went from an idea of doing a well conducted study, randomized trial and if it worked, all the practitioners decided to adopt it and use it. we treat heart attacks by going to the cath lab and using what works. ivermectin has been used in many

trials and no benefit but -- i use the word "worms" for the constant infections that typically occur in places like asia that can be devastating and got a nobel prize because it's effective for those and been a life-saver but it's been ineffective in covid. ms. crockett: i completely understand. the last area i'm going to touch on in my last 45 seconds because i'm a woman out of the state of texas and there's no way i won't talk about reproductive access. out of curiosity, would you consider the medical management of a miscarriage to be potentially a life-saving usage, yes or no? dr. califf: i have to be -- i have to decline to answer that. ms. crockett: that's perfectly fine. i'm going to tell you yes but give you another question you can answer.

would you consider erect i'll -- erect i'll dysfunction a -- aerectile dysfunction a lifesaving use for viagra. [dr. califf: not lifesaving. ms. crockett: meth press tone doesn't have life saving methods. i do appreciate the fact that you laid out that when it comes down to getting drugs approved, they actually go through trials. it's not just randomness. you take the randomness and then say maybe there's some evidence here and you put it through the ringer. after putting it through the ringer for decades, women's lives have been saved. and as a representative from the area that roe v. wade actually

initiated, i'm appalled because for whatever reason, some people want us to go back to horse and buggy in this country, and i think now maybe we have the internet, maybe we should take advantage of it and we shouldn't say we should remain in the times of horse and buggy. with that, thank you for the work that the f.d.a. does. i respect your research. i recognize the courts don't do research. i also recognize this chamber seemingly doesn't care about research but because of the work that you do, there are lives being saved and i need you to be funded to the fullest extent to make sure that we continue to save american lives. thank you. >> the chair recognizes mr. laturner from kansas. mr. laturner: thank you for being here today. the f.d.a. holds the responsible of ensuring the safety and integrity of the nation's food drugs and consumer products, a responsibility that not only impacts our economy but also the health and well-being of every american citizens. however, this f.d.a. has failed to meet its mission statement and is defined by crisis from

persistent drug shortages to the most instant disruptive to the infant formula in history. we can't afford to overlook these failures. the well-being of all america depends on it. i look forward to hearing from you today and on how to address these pressing issues. despite the backdrop of food and product safety issues plaguing your organization, the f.d.a. continues to chase nutrition related policies like front of pack labeling which are arguably outside of f.d.a.'s purview. can you explain to the committee what authority you feel f.d.a. has to pursue nutrition labeling policies while heavy metals exist in our food fly. a list of tobacco products remain accessible and 253 drugs remain in shortage. dr. califf: i have a lot of comments about food labeling that we're adhering to in this case. remind you, we have a shortened

life expectancy in this country particularly in rural areas that's largely driven by diet and poor nutrition. it seems to me, i'm just from south carolina, seems to me that putting the information on the front of the package is probably more likely to get the useful information so people can make wise choices. that doesn't seem to me like something that should be that hard to get to. if you put it on the back, if you're like me when you go to the story, you're unlikely to look at it. mr. laturner: can you tell me where you derive the authority? dr. califf: i'll get with your staff and go over the details but i believe we have the authority. mr. laturner: is it the best use of taxpayer dollars to shape america's eating patterns in lieu of tackling these other issues and i listed a few issues that seem like a big teal. dr. califf: tobacco is a huge one. but if we look at the fact we have the lowest life expectancy of any high income country, it's

being driven by chronic diseases which are being driven by diet. so to say we should pay no attention to diet is a mistake. now, shaping -- what we're doing is proposing to give people the information they need so they can make healthy choices and reduce these alarming rates of obesity, diabetes, vascular disease, i'm a cardiologist. i tell my colleagues we have no problem with business in the future in cardiology. mr. laturner: i only have a limited amount of time. i pointed to front of the package but appears the agency have goals that aren't related to food safety. the symbol for healthy and dietary guidelines for americans, dietary guidance statements, the list goes on. can you tell the committee and consumers how all these pieces fit together? my concern is that not only are you pursuing actions that you do not have the authority for, but you are also painting a terribly confusing landscape of rules and advice about what to eat.

dr. califf: well, i'd be happy to work with your staff on going through this in more detail but in short what we now know about diet, it's a pattern of eating over time is important and how long people live and whether they're burdened by chronic diseases. it's not one specific thing, it's multiple constituents of the diet when eaten regularly in a pattern creates the concept health problems that are ravaging our country right now. if you look at rural areas in particular, we're seeing alarming premature death rates going in the wrong direction, actually, for the first time in 50 years. mr. laturner: you said that earlier. my question is specifically all these different initiatives how they work together, and i look forward to getting an answer on that to my actual question. it's been brought to my attention illicit flavored e cigarettes now make up a majority of the entire e cigarette market which most of these products are coming from china. can you speak to the factors that allowed this issue to

materialize and what your agency plans to do to rectify the situation? dr. califf: thanks. i've been over this several times this afternoon but in brief, no one anticipates 27 million applications for vaping products when the door was open for applications. it has been a problem that is quite large and that we're gradually making progress in. mr. laturner: what are you doing about it? dr. califf: warning letters, civil penalties, injunctions and seizures, all the above. we hope we'll continue our presence out in the field. right now we get no user fees from the vaping industry and that money would enable us to put a lot more people in the field to take down these operations you're talking about. mr. laturner: it feels like warning letters aren't getting the job done. can you walk us through how you personally have communicated these concerns to d.o.j. and customs?

dr. califf: we had direct meetings and i've personally gone to several places of import to meet with the border patrol and customs people who are there when the stuff comes in. by the way, if you want to get an education on this, go to the international mail facility. mr. laturner: how about d.o.j. dr. califf: direct meetings and i have the phone number to call in off hours. >> the chair recognizes ms. tlaib. ms. tlaib: thank you, commissioner, we're almost done. i'm pleased you're here. i had the last two weeks, a handful of community events and f.d.a. issues did come up. i want to start with this, how much of what f.d.a. is doing covering specifically food safety, how much of your resources now is dedicated to food safety?

dr. califf: for detail, i would refer you to the reagan-udall report which has the information. ms. tlaib: is it 50%? dr. califf: nowhere near 50%. f.d.a. stands for food. on the medical side we had funding because of the medical fees but not on the food side. ms. tlaib: i do want to submit for the record an article, the f.d.a.'s food failure. >> without objection, so ordered. ms. tlaib: i want to talk about this because it comes up a lot. the f.d.a. right now has the authorization to regulate water to keep deadly toxin out of produce, right? dr. califf: the water is mixed. we regulate bottled water. the water supply itself is regulated by e.p.a. as just noted. water on farms goes from where cattle may be, for example, from plants. that's an area -- ms. tlaib: i

want to read an article. i think it was a couple months after you were affirmed. by the time the f.d.a. officials spyinged out it -- figured out it was spinach making people sick in three states and sending them in kidney failure was too late. the package salad short shelf life had passed and no recall. by the time they got the inspectors on the ground the spinach season was over and the field in the production facilities was empty and made it impossible to determine the source of contamination and make caused the outbreak was likely never fixed. have we fixed this kind of issue? again, what was suspected because of previous kind of contamination, it could be the water that's used to -- that touches the food, used to clean the produce. dr. califf: when you say "is it fixed" i would say the economist rated the u.s. food safety tied for first in the world and is it

completely fixed, of course not. ms. tlaib: i work on get the lead out caucus and people know i'm a leader on water. this is more of me trying to show my colleagues if we cared about food safety which every one of our constituents doesn't use every single medication they talk about but sure as heck gather produce, touch the food industry in every way. so i just want to get to the bottom of what we can do together to ensure you have authorization to oversee water quality that touches our food. dr. califf: we're finalizing -- there are 10 rules of the food safety administration. the agricultural water rule is one that's very pertinent and has to do with what farms should do if there are cattle upstream from where the produce is. and so, you know, there's a list of things we need. we can be in touch with your staff. ms. tlaib: we don't have anything right now that gives you authority over water, the use of water on produce?