FDA Commissioner Robert Califf Testifies Before The Senate Appropriations Committee

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On Wednesday, FDA Commissioner Dr. Robert Califf testified before the Senate Appropriations Committee on the FDA FY2025 budget request.   Fuel your success with Forbes. Gain unlimited access to premium journalism, including breaking news, groundbreaking in-depth reported stories, daily digests and more. Plus, members get a front-row seat at members-only events with leading thinkers and doers, access to premium video that can help you get ahead, an ad-light experience, early access to select products including NFT drops and more:  https://account.forbes.com/membership/?utm_source=youtube&utm_medium=display&utm_campaign=growth_non-sub_paid_subscribe_ytdescript   Stay Connected Forbes on Facebook: http://fb.com/forbes Forbes Video on Twitter: http://www.twitter.com/forbes Forbes Video on Instagram: http://instagram.com/forbes More From Forbes:  http://forbes.com

Transcript

00:00:00This hearing of the Agriculture Appropriations Subcommittee is now called to order,

00:00:05and I'd like to begin by welcoming FDA Commissioner Dr. Robert Califf,

00:00:10and thank you for being here today.

00:00:12I look forward to discussing the fiscal year 2025 budget request for the FDA.

00:00:18The responsibilities of the Food and Drug Administration are vast

00:00:23and impact the lives of nearly every American.

00:00:26We need to ensure we have the resources to continue your critical mission,

00:00:30and I'm committed to working with you during the appropriations process

00:00:33to provide the funding that you need.

00:00:36That begins now with the fiscal year 2025 budget request that's in front of us.

00:00:40The request includes a total of $3.695 billion in discretionary funding,

00:00:46a $168 million increase, a relatively modest increase for this agency.

00:00:52I am interested in hearing about your priorities within this budget request, Dr. Califf,

00:00:58and what role this committee can play in ensuring we continue

00:01:00to have the world's safest food and drug supply.

00:01:03I will say that I am frustrated with FDA's lack of urgency in regulating the tobacco products

00:01:09and e-cigarettes that are flooding the market, and I'm also concerned

00:01:13with highly pathogenic avian influenza and its potential impact to our food supply.

00:01:18I continue to be interested in investing resources in our domestic infant formula supply

00:01:24as we continue to recover from the 2022 formula crisis.

00:01:29All of these issues continue to be public health threats to our nation,

00:01:32and the FDA should be using all tools available to address them.

00:01:37I look forward to hearing your thoughts on these issues and what FDA is doing to address them.

00:01:41Dr. Califf, I want to reiterate my continued support for FDA

00:01:46and the dedicated employees at your agency.

00:01:49Last year, we had to make some pretty difficult budget decisions under grim spending caps,

00:01:54and I'm afraid that it is likely this year will not be much better.

00:01:58That's why it's important for us to hear your priorities

00:02:01and the priorities of members of this committee.

00:02:05And thanks again for being here, and I'll turn things over to my Ranking Member, Senator Hoeven.

00:02:11Thank you, Mr. Chairman, and Dr. Califf, thanks for being here and for your service

00:02:18as the leader at FDA, an incredibly important position.

00:02:22I know it's been a busy time since your return as Commissioner from the COVID-19 pandemic

00:02:28to the infant formula crisis and the current highly pathogenic avian influenza outbreak,

00:02:34which we'll talk about a little bit, among dairy cattle,

00:02:37as well as ongoing drug and device shortages.

00:02:40So, all of that on top of what you have to do every single day, which is, of course,

00:02:44to keep the food and drug supply safe for, you know, well more than 300 million Americans.

00:02:51Your agency has authority over 160 foreign establishments and 135, excuse me,

00:02:57160,000 foreign establishments and 135,000 domestic establishments, which is really incredible.

00:03:06And that ranges from food processing plants to facilities

00:03:11that manufacture life-saving medications, also countless individual products.

00:03:19So, I appreciate that when it comes to keeping food and drugs safe and effective,

00:03:26you've got to get it right, and you've really got to get it right every single time,

00:03:29which is an incredible task, and that's, of course,

00:03:32why we provided the budgetary increases, you know, that we have,

00:03:35which have been substantial over the last 10 years, and Americans expect that.

00:03:40I mean, they expect, you know, you've set a high standard, and they expect that to be maintained

00:03:47in an ever more complex and interconnected world.

00:03:51So, there's a lot of things we'll talk about today.

00:03:54Obviously, no shortage of food safety issues.

00:03:59I appreciate the steps you're taking in terms of the RE-ORG.

00:04:02I know that's been a massive task, and we'll want to talk about how that's going.

00:04:08Also, I'm concerned in your budget plans for adequately funding state food inspectors,

00:04:15which we'll want to touch on, and then the drug shortage we're seeing

00:04:20across the country with various drugs, and that's something

00:04:26that we'll need to discuss here as well.

00:04:30Also, the rare diseases, lab-developed testing regulations,

00:04:34and, of course, artificial intelligence, right?

00:04:38So, a lot of important topics in your job, it's kind of like you touch

00:04:45on everything, and everybody, every day.

00:04:48Thanks for being here.

00:04:48I appreciate it.

00:04:51Dr. Kalen?

00:04:53Thanks. Your comment about everything, every day.

00:04:56I just had my 55th high school reunion, and everyone there had some opinion

00:05:01about what the FDA should or should not be doing, I can assure you.

00:05:06So, Chairman Heinrich and Ranking Member Hoeven, and members of the subcommittee,

00:05:11thanks for the chance to be here before you today.

00:05:15I do want to start by thanking the subcommittee for your continued support of the FDA.

00:05:19In a difficult fiscal environment, the agency greatly appreciates the subcommittee's sustained

00:05:25commitment to our mission.

00:05:27The budget I'm pleased to present to you today requests a total of $7.22 billion

00:05:32for the agency, an increase of $341 million above the FY 2024 enacted levels.

00:05:39Looking ahead to FY 2025, we intend to take significant new steps in our approach

00:05:44to addressing our numerous challenges, in particular,

00:05:49through the largest reorganization in the history of the FDA.

00:05:52Virtually every component of the agency will be impacted in some way by the changes,

00:05:57which will affect over 8,000 of our 18,000 employees.

00:06:01At the center of this reorganization, we're building a newly unified human foods program.

00:06:07Following the independent evaluation by the Reagan-Udall Foundation and an internal review,

00:06:11we're bringing together human foods functions, resources,

00:06:15and personnel from across the agency, all under a single leader.

00:06:19Importantly, this new human foods program will create a clear line of authority.

00:06:24The new deputy commissioner has full decision-making authority over the entire program.

00:06:29We're also renaming the Office of Regulatory Affairs as the Office of Inspections

00:06:34and Investigations, signaling a refocusing of that office on its core function of inspections,

00:06:42investigations, and import operations, eliminating duplication and increasing efficiency

00:06:48in how we handle these activities.

00:06:51As part of this effort, we're shifting the Office of Regulatory Affairs, medical products,

00:06:55tobacco products, and specialty labs into the Office of the Chief Scientist

00:07:00to form a highly integrated network of laboratories and laboratory scientists

00:07:04that provide coordinated, cutting-edge regulatory science research

00:07:09and support for all of the FDA.

00:07:11Additionally, we're making a number of other realignments to further improve efficiency

00:07:17and communication across the agency, including moving cosmetics functions to the Office

00:07:23of the Chief Scientist, which is best positioned to support scientific expertise necessary

00:07:28to review cosmetic ingredients and implement the new authorities provided

00:07:33under the Modernization of Cosmetics Regulation Act.

00:07:37The FY 2025 budget request will provide a solid foundation

00:07:41for these newly envisioned programmatic changes,

00:07:44as well as strengthen the agency's capacity to protect and promote a safe

00:07:48and secure U.S. food and medical product supply.

00:07:52Outside of the reorganization, we're also looking to make significant strides

00:07:56in other critical cross-cutting areas.

00:07:58For example, the past four years have demonstrated the importance of managing supply chains

00:08:04and mitigating shortages of critical products.

00:08:07Our FY 2025 budget requests $12.3 million for supply chain work across nearly all product areas,

00:08:14as well as establishing positions to coordinate these activities across the agency.

00:08:20Finally, I also want to emphasize the importance of the agency's modernization

00:08:24of IT infrastructure and data processes at the FDA.

00:08:27We're requesting an increase of $8.3 million to further build

00:08:32on our centralized enterprise data modernization capabilities, as well as $2 million

00:08:37to implement common business processes and data optimization.

00:08:43The rapidly changing world demands that our systems evolve to meet future needs.

00:08:48This includes incorporation of computing advances like artificial intelligence

00:08:53and advanced cybersecurity methods to protect our data and information.

00:08:58The industries we regulate in our own workforce have focused on the use of AI coupled

00:09:03with better data and sophisticated computing infrastructure for innovative ways

00:09:08to benefit public health, from efforts to detect contamination patterns and screenings

00:09:14for imported food products, to helping to identify potential cancer therapies

00:09:20for certain ultra-rare cancers.

00:09:22Finally, we've contributed significantly to the joint effort to deal

00:09:27with the highly pathogenic avian influenza outbreak,

00:09:31and I'm pleased that our supply of milk products is safe.

00:09:34However, this virus, like all viruses, is mutating.

00:09:38We need to continue to prepare for the possibility that it might jump to humans.

00:09:44Thank you for inviting me today, and I look forward to answering your questions.

00:09:48DR. KALUF.

00:09:49Dr. Kaluf, why don't you start right there and just talk a little bit

00:09:52about what that preparation looks like.

00:09:56DR. KALUF.

00:09:57Sure. First of all, it's important, as you all know, we've talked about One Health

00:10:01for a long time, the fact that we all live in a world and a universe where animals

00:10:07and humans are more and more connected because of international transportation,

00:10:12the fact that more people are living closer to farms and on farms.

00:10:17But this is a real example of One Health.

00:10:20Just roughly speaking, it's always a little more complicated than just the first take on it,

00:10:26but essentially, the Agriculture Department regulates the cows.

00:10:30We regulate the milk at the FDA, and the CDC has primary responsibility

00:10:35for the health of the workers.

00:10:37On the dairy farms.

00:10:39And so we all have to work together across these organizations

00:10:43and agencies to take care of things.

00:10:48And there's so many aspects I can't go through it all,

00:10:52but primarily from the FDA perspective today, we are accountable for the milk.

00:10:57So when we heard about the problem, we needed to launch a program of testing the milk

00:11:05to make sure that it was safe, knowing that it was likely

00:11:09that there were more infected herds than we initially knew.

00:11:13And in fact, that's what we found.

00:11:15As you well know, when we looked at just milk before pasteurization,

00:11:21that is the raw milk coming into the bulk tanks, about 20% of a national sample turned

00:11:28out to have fragments of virus in it.

00:11:32And then the question was, is this infectious virus or is it essentially fragments

00:11:38of dead virus that had been taken care of by pasteurization?

00:11:43We had a good reason to believe pasteurization would work

00:11:45because of 100 years of pasteurized milk.

00:11:48And in fact, it did.

00:11:49We found no evidence of live virus.

00:11:52And I'm pleased to say there are many NIH and Agriculture Department researchers

00:11:58around the country, universities who were also looking, and we all found the same thing.

00:12:04But now, the other part that we're accountable for at HHS

00:12:08and within FDA is the countermeasures in case this does jump to humans.

00:12:13So we've got to have testing, got to have antivirals,

00:12:16and we need to have a vaccine ready to go.

00:12:19So we've been busy getting prepared for if the virus does mutate in a way that jumps

00:12:27into humans on a larger level.

00:12:30Throughout all of this, because there's so many agencies involved, countless hours

00:12:35of phone calls and Zoom conferences to make sure that we're all coordinated,

00:12:41all in an environment where, let's just say, it's not easy to get access to the farms

00:12:51because people aren't understandably protective of the environments in which they work.

00:12:57So a lot of work across the agencies here.

00:13:00And I feel like it's been a good example of how one health can come together.

00:13:07Right. Dr. Califf, how do you see infant formula being managed

00:13:13under the new Human Foods Program?

00:13:16Well, I'd really like to answer that question in two parts.

00:13:20And I think you may remember the day I was confirmed was the day of the Abbott recall.

00:13:24So it's not a very warm welcome to the FDA to hear that this is going to unfold.

00:13:32And so the first part is what we've already done.

00:13:35Because just a comment about the reorganization.

00:13:40I'm sure we'll talk more about it with other questions.

00:13:42But we can't enact a reorganization until we get through congressional notification process.

00:13:49We're still waiting on one branch of the four corners to give us the okay.

00:13:55Then we have to negotiate or really reach agreement with the unions,

00:14:00which I don't think is going to be a big problem.

00:14:02But the unions that represent 80% of our employees have a right to have a say.

00:14:07And then we're ready to go.

00:14:09We're amassed at the starting line to really get going.

00:14:13We have hundreds of people across the FDA who have volunteered to be champions

00:14:17of change in this massive reorganization.

00:14:21But in the interim, because of the urgency of the infant formula issue,

00:14:27we've already done a lot of the work that we had to do.

00:14:30We now have many more people working within currently CFSAN, the food part of the FDA,

00:14:37on this sort of basic science and regulation that needs to go on.

00:14:42And we've beefed up the inspectorate.

00:14:45So they're called investigators at the FDA.

00:14:47We have a dedicated core.

00:14:49All of the infant formula facilities are being inspected at least once a year.

00:14:54In the case of the Abbott plant, there's a consent decree.

00:14:56So we're essentially there every day talking with them.

00:15:01And as issues come up, dealing with them jointly.

00:15:05But it's a whole different world now that the scientific experts, the investigators,

00:15:13and the leaders meet on a regular basis, plan the inspections.

00:15:17And when things are found, they're dealt with very quickly as compared to a process

00:15:21which in the routine prior, you know, it took some time to institute the changes.

00:15:28So and we have, as you know, hired Jim Jones as head of the Human Foods Program,

00:15:36although it's not the Human Foods Program yet until we.

00:15:39And this better decision-making structure, there was nothing wrong with the people

00:15:44that were trying to make decisions before.

00:15:46But it was not optimally organized to lead to crisp decisions

00:15:51that would lead to action being taken.

00:15:53Great. Working member Hovind.

00:15:55Thanks, Mr. Chairman.

00:15:56Yeah, I feel like the question just always with these issues leads to more questions.

00:16:02On the avian food, now that has jumped to humans in some, I know there was a case in Texas,

00:16:08and has gone from cattle to humans already in some cases, correct?

00:16:12Yeah. So you might enjoy just a quick note about the biology here.

00:16:18Not that I'm, I mean, I'm a doctor, not a clinician, not a biological scientist.

00:16:24But the attachment of this virus is through receptors that deal with something called sialic acid

00:16:31that are ubiquitous in all animals, including people.

00:16:35And it turns out the human conjunctiva apparently is the one part of the human

00:16:41that right now is susceptible.

00:16:43And so the one case that we have was conjunctivitis.

00:16:46Not a serious illness, but conjunctivitis.

00:16:51And that case has been worked up by the CDC as best they could.

00:16:56But like all viruses, it comes and goes.

00:16:58So you got to really catch it while the person is actively infected

00:17:03to do all the things that you'd like to do.

00:17:06The real worry is that it will jump to the human lungs, where when that has happened

00:17:11in other parts of the world for brief outbreaks, the mortality rate's been 25%.

00:17:16So one in four, that's about 10 times worse than COVID.

00:17:20And so it's really, you know, we don't control how the virus mutates.

00:17:26And it's just a mathematical, viruses are always mutating.

00:17:29It's a mathematical probabilistic thing where the mutation will make it able

00:17:35to attach to these receptors in the human lining of the lung.

00:17:40That would make it perhaps transmissible through the airways, which would be really bad.

00:17:46So we have to be ready, and we have to do everything we can to limit the spread of the virus,

00:17:51which has gone around the world multiple times now in many different species.

00:17:56But there's debate, but there's a concern that when it invades cattle for the first time,

00:18:04which are closer to the human being than a bird, say, and the cattle are often intermingling

00:18:09with pigs on farms, and with farm workers.

00:18:14You know, a lot of the experts have told us they're particularly worried right now.

00:18:19So the public need not be worried.

00:18:22The risk is still low that that will happen.

00:18:24But it's sort of like I've, this may be a bad analogy,

00:18:28but I think of it having had relatives go through this.

00:18:31I would rather have the low-deductible insurance than the high-deductible insurance.

00:18:36That is, if we institute the countermeasures now and reduce the spread of the virus now,

00:18:43then we're much less likely to see a mutation that jumps

00:18:46to humans for which we're ill-prepared.

00:18:49So the investment now and the careful attention to management of the herds on the farms is really,

00:18:57and part of our job at FDA, we'll have an active surveillance system on the milk

00:19:03so the public can be reassured that this, you know,

00:19:06critical part of the food supply is staying safe.

00:19:10So, I mean, it's moved from birds to cattle.

00:19:14And that process, you've got to be very careful.

00:19:16Cattle, possibly hogs, or ultimately to people.

00:19:21How do you create a barrier there that both, you know, the actual animal

00:19:27and then the byproducts, I mean, how do you create a very good barrier there

00:19:32so people are comfortable you've got this thing, you know,

00:19:35contained or stopped from further migration?

00:19:37Unfortunately, there is no absolute barrier that can be created.

00:19:43But there are elements of protection that are important, like farm workers,

00:19:48if they're on a farm with infected cattle.

00:19:51And one good thing here, the cattle don't die.

00:19:54The mortality rate of cows with this virus is less than 1% from what we're told.

00:20:00So the cattle will recover.

00:20:02But the workers need to be protected with PPE, just like we all went

00:20:08through with hospital workers with COVID when you're around animals that are infected.

00:20:14In the poultry industry, as you may know, they've already been through this.

00:20:18And the use of PPE is just routine in the poultry industry.

00:20:23This is new for the cattle industry.

00:20:27And so there's a lot of work to be done to get to the right place there.

00:20:31Is this our future with viruses where we're just going to have to be across the board,

00:20:37having that kind of, you know, the equipment and the garb and everything to stop it?

00:20:43You know, there's such a hard balance here for people like me because it's 25 years.

00:20:50If you look at all the literature and the establishment in the government of elements

00:20:57of protecting against future pandemics, this has been predicted just a matter of time.

00:21:02I mean, it happened in 1918.

00:21:05That was probably a very similar incident of bird to human or something like that.

00:21:10And so we're going to see these things cycle through.

00:21:13And what we want is to be better and better at dealing with it when it happens.

00:21:18And as we learn measures to prevent it from happening, try to do it.

00:21:21But like I say, there is no absolute barrier that we know of now.

00:21:25So it's when there's an outbreak containing it, which, you know, that would mean, for example,

00:21:32what's happening now is not shipping.

00:21:34I'm not an expert on cattle ranching, but cows get sold all the time and move across state lines.

00:21:43So containing it means if you've got an infected herd, not doing that.

00:21:47And that's happening now.

00:21:49And I think it's been successful.

00:21:52But it also means having those countermeasures ready to go.

00:21:54So you got the antivirals, the vaccines, the monoclonal antibodies ready to go,

00:21:59just in case it happens.

00:22:03So it's not new.

00:22:04It's going to be part of our lives.

00:22:07It probably happened a lot more historically in ways that we didn't even know

00:22:11because we didn't have ways of measuring it.

00:22:14Thank you.

00:22:15Senator Baldwin.

00:22:17Thank you.

00:22:20You mentioned your high school reunion.

00:22:21I'm heading to a big reunion in a couple weekends.

00:22:25And I'm sure I'm going to hear everyone will have an opinion

00:22:28on what should be happening in Congress.

00:22:31You're hearing from your old classmates.

00:22:35Anyways, thank you for joining us today, Commissioner.

00:22:37And I'm going to continue on the same theme that previous senators have asked

00:22:45because I represent America's dairy land.

00:22:48And the outbreak of avian flu in dairy herds in the United States is a significant issue.

00:22:57Wisconsin's home to over 5,000 dairy farms, dairy herds,

00:23:02and roughly 22% of the nation's total herd count.

00:23:07So this is a big deal for us.

00:23:10As you can imagine, Wisconsin farmers and dairy producers are concerned

00:23:14about its potential to spread to their own operations.

00:23:18Two weeks ago, I sent you a letter requesting robust coordination and communication

00:23:25on highly pathogenic avian influenza in order to protect our nation's farmers,

00:23:33workers, and dairy supply chain.

00:23:35So I'm really interested in, you know, you outlined already the different agencies

00:23:41that have a role in this, human health, health of the herd, health of the food supply.

00:23:47Please talk about those, that coordination and communication and how it's happening.

00:23:57Well, I would point to multiple levels of coordination.

00:24:00At the highest level, the OPPR, which you all helped create through legislation

00:24:05in the White House, coordinates across agencies.

00:24:09I mean, as you all know, the Agriculture Department is a separate department.

00:24:13FDA is within Health and Human Services.

00:24:17And so there's an office there which has a call every single day where leaders,

00:24:22in fact I'm missing the call today, but the leaders of each

00:24:27of the relevant agencies review what's happened the previous day,

00:24:31what the plan is, and what the long-term plan is.

00:24:35And then within HHS, because we have CDC, ASPR, and FDA in particular who have to be involved,

00:24:43we have a separate call every day just for the HHS part of it to make sure

00:24:48that we have our act together as it relates to human health.

00:24:53And of course at FDA we have a cross thing because we also have the Center for Veterinary

00:24:57and Medicine and the animal involvement.

00:25:00So there is a lot of coordination.

00:25:04I think it's going well and it's very strategic, but we do have some hurdles.

00:25:13And I just say well beyond that, you also know that the states play a huge role

00:25:17in the management of the safety of the food and farms in particular.

00:25:25And so we're constantly in touch with all the regulators in the states.

00:25:30And every state system is different in terms of how it's configured.

00:25:35So access to the farms, for example, is something that really has to be negotiated

00:25:39through the states, the farmers, and the owners of dairy farms are more comfortable

00:25:46with people that they know that are in their states.

00:25:50So all this has to be coordinated.

00:25:52I feel like we're doing a good job of that.

00:25:55Let me just ask a little bit, you talked about the difficulty in getting access to the farms,

00:25:59but you mentioned earlier the ability to test unpasteurized and then test pasteurized milk.

00:26:06Are you having any difficulty at the processing stage of getting that access?

00:26:14The pasteurized milk is absolutely no problem to test because we just have,

00:26:19we have people that go to stores and buy milk off the shelves anyway for all sorts

00:26:24of other testing.

00:26:26As I'm sure you know from the state that you're in, you have all these cows,

00:26:33the milk goes into bulk tanks, which is a mixture of a number of cows.

00:26:37And that's a very sensitive area because it does point

00:26:42if they're infected cows as to where the infections are.

00:26:46And technically it's no problem, but we want to make sure that we have trust.

00:26:51And so there's negotiation that needs to go on to make sure that there's a safe way

00:26:56to handle the data and that people are not going to be castigated

00:27:00if they happen to have an infected herd.

00:27:02So we're working through all that state by state.

00:27:06Okay. And can you share if you need any resources in order

00:27:14to increase your testing and treatment capacity?

00:27:21Well, as you might imagine, we've expended a lot of resources

00:27:25in the absence of any additional funding.

00:27:27And we're keeping track of that and looking at potential sources within,

00:27:31in our case, within HHS, for example.

00:27:34I think it's predictable that we're going to be in a new environment for milk in particular

00:27:43because of this virus, the way it's affected other species as it sort of cycles around.

00:27:50And one thing about cattle, they don't, there are always new cattle coming up.

00:27:56So there are always going to be naive cattle that are susceptible to getting infected.

00:28:03So it's predictable there will be a need for resources.

00:28:06We're keeping track of things.

00:28:08And as we get a handle on what we need to do going forward,

00:28:11we'll keep you completely informed about where we stand,

00:28:14including the reserve opportunities within HHS.

00:28:20Thank you, Dr. Califf.

00:28:22Senator Hyde-Smith.

00:28:24Thank you, Mr. Chairman.

00:28:25And thank you for being here today, Dr. Califf.

00:28:29I want to talk about medical gases.

00:28:32I hate to drive this nail into the wall, but I have not seen any movement on this issue.

00:28:38So we're going to continue to pursue this because I have constituents

00:28:43in Mississippi that this really affects.

00:28:46I have repeatedly brought up the issue of medical gas,

00:28:48whether in previous hearings and several letters.

00:28:52And my colleagues and I continue to push on this issue.

00:28:56Congress required the FDA to update its regulations for medical gases in July of 2016.

00:29:04And almost eight years later, the FDA has still failed to fulfill its obligation

00:29:09to the millions of American patients who rely on medical gas daily.

00:29:15My colleagues and I have consistently encouraged the FDA to meet its statutory requirement

00:29:20and promulgate rules for medical gases.

00:29:24But instead, the FDA continues to regulate medical gases under regulations written

00:29:29for traditional pharmaceuticals that do not share the unique characteristics

00:29:35of this category of drug products.

00:29:38While I appreciate the fact that the FDA finally issued its long-overdue proposed rule

00:29:44for medical gases in 2022, this month will mark two years since the rule was even published.

00:29:53The FDA only received four, one, two, three, four public comments,

00:29:57and yet your agency still has not published final rulemaking.

00:30:03And there's just really no excuse for the delay.

00:30:06It's time to finalize the rule.

00:30:09So what is your plan for publishing a final rulemaking in the 2024 calendar year?

00:30:17Yeah, I'm not going to beat around the bush about this.

00:30:20I distinctly remember your bringing this up last year, and I also told you that time.

00:30:25It was a long time ago, but I was actually a co-founder of a medical gas company.

00:30:30So, you know, the company no longer exists, so I don't have any conflict related to this,

00:30:37but I feel like I have a good understanding of it.

00:30:40What I'd say is just a couple of quick things.

00:30:45This rule involves every single part of FDA, and there has been a lot of negotiation that need

00:30:52to go on to make sure that we get it right as it affects things like veterinary health

00:30:57and biologics and devices and drugs, all relevant here.

00:31:04I also say we have a published date to have this concluded by October of 2024.

00:31:12So October of 2024 is when we can expect the final rule?

00:31:16I'd say before then.

00:31:18Wonderful, wonderful news, because I don't want to have to ask it again next year.

00:31:23I know you don't, and I don't want to have to take the question again.

00:31:27I'd love to see this thing out, and I can't give you the exact date, but I think you'll be—

00:31:32Okay, that's good enough, and I still have some time left,

00:31:34and I want to talk about the illegal advance prescribing.

00:31:40I've repeatedly brought to your attention to the dangers the women face

00:31:43when allowed dangerous life-ending chemical abortion drugs,

00:31:47which can be ordered by consumers through the mail,

00:31:51are purchased in retail pharmacies without ever seeing a doctor in person.

00:31:56My husband has a doctor's appointment Friday morning for a sinus medication

00:32:00that he can't get refilled until he sees a doctor.

00:32:04So it blows me away that you can get this with no doctor oversight,

00:32:09and it is a drug that will literally cause you intentionally to have an abortion

00:32:16and end your pregnancy and the life of that child.

00:32:19The FDA is supposed to protect Americans from taking medications that could be harmful.

00:32:25However, you continue to look the other way and claim that mifepristone is safe,

00:32:32in part based on the lack of reports of non-fatal adverse events

00:32:38due to the FDA's own relaxed reporting requirements

00:32:41and continue to allow the women to put their lives at risk

00:32:45in the name of the pro-abortion agenda.

00:32:48And it has been reported on more than one instance

00:32:52that American women are stockpiling the abortion pills

00:32:58through advanced prescribing from abortion companies and providers.

00:33:03And according to another article in Politico,

00:33:07an FDA spokesperson stated that the FDA is concerned about the advanced prescribing of mifepristone

00:33:14and that mifepristone is not approved for advanced provision of a medical abortion.

00:33:21It's not even approved for that, and they can get it without even seeing a doctor.

00:33:26So what concerns does the FDA have with the advanced prescribing of this mifepristone?

00:33:35And is it true that the FDA has not approved mifepristone for advanced provisions of an abortion?

00:33:41And I have two follow-up questions with that.

00:33:45Well, I know you're aware that I'm limited in what I can say

00:33:47because the issues around this are currently under consideration by the Supreme Court.

00:33:52But what is FDA doing?

00:33:55Well, remember that, first of all, just one technical point to make

00:34:00is that there has to be a prescription.

00:34:03The companies can't write prescriptions, so it's doctors that are writing prescriptions.

00:34:06Without seeing a doctor, though.

00:34:08Without physically seeing the doctor, they can just write the prescription with no visit.

00:34:13Like the sinus medication that he has to go in to see the doctor.

00:34:16Remember that we don't regulate the practice of medicine.

00:34:19So there has to be a doctor that writes the prescription.

00:34:22And the conditions under which that is done are...

00:34:26But when they're violating the law by allowing them to stockpile,

00:34:31what is your responsibility then?

00:34:34We don't advocate stockpiling as a method,

00:34:38but again, we don't regulate the practice of medicine.

00:34:42So you have no role whatsoever in preventing the stockpiling of this?

00:34:52I don't know how we would.

00:34:54Senator, your time has expired.

00:34:56Thank you.

00:34:58Senator Peters.

00:35:00Thank you, Mr. Chairman. Dr. Calef, good to see you again here.

00:35:04In 2021, the FDA found that some infant formula products had been released to the public

00:35:11while contaminated with chronobacter.

00:35:14This didn't just cause widespread panic and a nationwide formula shortage,

00:35:19it also revealed, I think, the effects of a glaring problem

00:35:23that the FDA does not currently have the authority to inspect infant formula

00:35:28until after the product has left the manufacturer's control.

00:35:33The FDA's two past budgets have requested additional authority

00:35:37to require industry to conduct testing of final infant formula products.

00:35:42And I've been working on legislation to provide this authority

00:35:45that is so essential for you to protect infant formula.

00:35:49The bill would require infant formula manufacturers to test for key contaminants

00:35:53before releasing their product out to the public

00:35:57and give positive test results to the FDA.

00:36:01So my question for you, sir, is if the FDA had the authority to test infant formula products

00:36:07before they went out to the market,

00:36:09how would that prevent future recalls and potential supply chain difficulties

00:36:14like we saw during 2021 infant formula crisis?

00:36:19I really do appreciate the question and the background there.

00:36:23You are correct that there is no requirement of reporting to the FDA

00:36:29the results of testing that companies do, even if they find bacteria.

00:36:33They're accountable for getting rid of those lots and not putting them into circulation.

00:36:39But it would really help us a lot if there were a requirement for testing

00:36:43and if the tests are positive, that we be notified.

00:36:49So in the case of the recall that we had,

00:36:51there were just a lot of bad conditions in that one plant.

00:36:55We would have known about that a lot earlier

00:36:57had we known about the results of testing the companies do.

00:37:01And I might add, in most of our regulatory paradigms,

00:37:04the first line of defense is the industry that we regulate,

00:37:08like in the production of medications.

00:37:11We don't test every lot of medications,

00:37:13but the company that manufactures the drug is required to do it

00:37:16and to have the records available for us to look at.

00:37:19And we'd like to see the same thing happen not only with infant formula,

00:37:23but also with regard to all critical foods, particularly for children.

00:37:28You're aware that we recently had the contaminated applesauce with lead.

00:37:32So we are asking Congress to give us the authority to require that that be done.

00:37:38Great. Thank you.

00:37:40Last year, one of my constituents, Sandra Isenga,

00:37:43lost her life after being treated for a tuberculosis infection

00:37:47with a contaminated bone graft from Osseobiologics.

00:37:52Her case, I think, just shows how dangerous it is

00:37:54when TB is spread through the transplantation of human cells,

00:38:00tissue, as well as cellular-based products.

00:38:03Inspected lots were not just sent to Michigan,

00:38:07but also to California, Louisiana, New York, Oregon, and Texas.

00:38:11And this was the second outbreak from this company,

00:38:15which is also responsible for a 2021 outbreak

00:38:18that infected 80 and killed eight people.

00:38:22I remain concerned that we're not doing enough

00:38:24to stop the spread of TB through transplantation of human cells,

00:38:28issues in cellular-based products.

00:38:30And that's why I've introduced legislation

00:38:32that would conduct an educational campaign

00:38:34about the risk associated with human cell and tissue transplants,

00:38:39and would allow for civil monetary penalties

00:38:41for companies that violate compliance standards,

00:38:45similar to that of traditional medical devices or tobacco products.

00:38:50So my question for you, sir, is,

00:38:52does the FDA have the resources it needs to ensure

00:38:54that all registered human cell and tissue establishments

00:38:58are being properly inspected?

00:39:01Again, I really appreciate the work you're putting into this,

00:39:05and I'll just say the issue of cell and tissue therapy

00:39:09is one of the most promising things that we have in our armamentarium

00:39:13of developing treatments to prevent and treat human disease.

00:39:18But it also has a downside, and it gets very complicated

00:39:20because it intersects with the practice of medicine issues

00:39:24and very complicated interpretation of regulations

00:39:28about the type of tissue used

00:39:30and how much it falls into a category more like a drug or a device

00:39:37in terms of the way it's regulated.

00:39:39So your efforts to clarify this are much appreciated.

00:39:42It's a focus of ours.

00:39:45The civil monetary penalties will be a big help to us

00:39:48because it's murky, it gives bad actors a chance to do bad things

00:39:54in a way that's hard for us to stop.

00:39:56When we have so many good actors who are doing so much good

00:39:59with this type of treatment,

00:40:01also applaud your efforts at education.

00:40:05It is a complicated area.

00:40:06When you hear about stem cells and cell therapy and such,

00:40:11it's very exciting, but the details are important.

00:40:14And if there are, like I say,

00:40:18some people not acting above board in this regard,

00:40:22I don't want that to detract from the majority of people

00:40:24who are really breaking new ground

00:40:27in ways that are going to be very good for human health.

00:40:29Right, absolutely.

00:40:30But we do have to have the oversight, so I appreciate it.

00:40:33Thank you for your comments.

00:40:33Thank you, Mr. Chairman.

00:40:35Senator Manchin.

00:40:36Thank you, Mr. Chairman.

00:40:37Dr. Haliff, last year during your previous testimony

00:40:39before the committee, the FDA held an advisory committee meeting on opiates,

00:40:43which you know is extremely devastating to this entire country,

00:40:46especially to my state of West Virginia.

00:40:49In particular, the questionable clinical trial practice

00:40:52known as enriched enrollment.

00:40:54The enriched enrollment process has made it significantly easier

00:40:57for FDA to approve opiates

00:40:59and allow for broad marketing to the public.

00:41:01The process removes the patients

00:41:04with pre-existing opiate sensitives from clinical trials

00:41:07instead of sticking with traditional double-blind studies.

00:41:11This has skewed results and seriously underestimates risks

00:41:13associated with the proposed drug involved in the clinical trial.

00:41:17The advisory committee last year expressed concerns

00:41:19during the meeting about the enriched enrollment

00:41:23is able to really address whether an opiate is better than a non-opiate.

00:41:27In September, I sent you a letter asking for an update on FDA

00:41:31and doing a response to these concerns.

00:41:33We haven't heard a thing.

00:41:35So what have you done in response to concerns raised

00:41:39regarding the enriched enrollment?

00:41:42Well, Senator, thanks for the question.

00:41:43As we've discussed before, I'm a clinical trialist by profession.

00:41:46It's been my whole career.

00:41:48So I certainly understand the issue that you're raising.

00:41:53And you know that we had the advisory committee meeting.

00:41:57The advice is publicly available.

00:42:01And we take it seriously.

00:42:02I don't think you'll see enriched enrollment

00:42:05as a practice in the routine management of the affairs of opioids.

00:42:12There are other circumstances in medicine and health care

00:42:15where it's a very important constituent of the armamentarium

00:42:20of clinical trial methods that are important to have available.

00:42:24Well, let me go into this then.

00:42:25And one of the recommendations in the external review

00:42:27of the FDA regulations of opiates report that you ordered

00:42:30was to ensure the FDA be as transparent as possible

00:42:33regarding decision making, which I appreciate.

00:42:36Advisory committees present complex scientific reviews

00:42:38of safety and efficacy of medicines.

00:42:42And most patients and the general public

00:42:44really don't have a background to fully understand

00:42:46the scientific studies which you're explaining.

00:42:49But the FDA announced that it will be holding a listening session on June 13th

00:42:54to discuss the role of advisory committees

00:42:56specifically to improve the public understanding.

00:42:58One element that you have stated is to reduce voting.

00:43:03How can you reduce voting with these scientists

00:43:06and like yourself being in that position before

00:43:08if you can't vote to where you think something's effective or not?

00:43:11And that leads into another question.

00:43:13I can never believe this happened, okay, with Zohydro.

00:43:16When Zohydro, I don't think you were there at this time,

00:43:1911 to 2, the advisory committee voted against putting this product on the market.

00:43:25And at that time, I think she was the head, Woodcock was the head of it,

00:43:30did it anyway.

00:43:32And I could not believe it, could not believe it.

00:43:34So if you take voting out of the process, what would be that?

00:43:39I don't know, Senator, I don't know of anyone who's,

00:43:42first of all, as a clinical scientist,

00:43:45the epitome, the peak of my academic career

00:43:48was being on the Cardiorenal Advisory Committee

00:43:50where everything comes together.

00:43:52I don't know of anyone who's advocating taking voting completely away.

00:43:56It's reduced voting.

00:43:58Let's remember, advisory committees are to give advice to the FDA,

00:44:04often not about a particular product, but about a field,

00:44:08how to think about a field,

00:44:09where the vote doesn't particularly have a purpose.

00:44:13In addition to that, what the FDA is most interested in

00:44:16is what the advisory committee is thinking,

00:44:19what's behind the reasoning for the way they feel the way they do.

00:44:23That's much more important than the sort of excitement

00:44:26of having a vote from people that have convened for one day

00:44:31without all of the background that the FDA has,

00:44:34that's been meeting and looking at the data for months.

00:44:38So the advisory committees are very important.

00:44:40I'm a big proponent of having them.

00:44:43We just need to make sure that they're meeting the purpose for which they exist.

00:44:48And with regard to votes that go the other way,

00:44:52if we always took the advice of advisory committees,

00:44:55we wouldn't need the FDA, just convene an advisory committee.

00:44:58So there's a-

00:44:59These scientists give you a different opinion.

00:45:01The only thing I look at an advisory committee,

00:45:03these are people that are not beholding to the company

00:45:05that's asking you to approve a new patent or whatever it may be.

00:45:10Well, there are people-

00:45:11Let me just say this, because our time is very limited.

00:45:14And the thing that the-

00:45:16Opiate is just a scourge on our society.

00:45:18It's been for quite some time.

00:45:20It's devastated my state in ways that you can't even believe.

00:45:23And what it's done around the country,

00:45:25we've killed more people with overdoses

00:45:28than we have in any wars we've ever fought in,

00:45:30starting back from the Civil War.

00:45:32But I can't never figure out why do we allow,

00:45:35I mean, and evaluate if a new product is coming on the market,

00:45:38your job is to make sure it's an improved product

00:45:41that'll reduce the suffering of humans.

00:45:43It's better for a society.

00:45:46And these products keep coming at you all

00:45:48and they're not taking anything off.

00:45:49If something's gonna improve and be better,

00:45:51then don't you think something should be removed

00:45:54from the market?

00:45:55They're just flooding the market

00:45:56with the things they've had forever,

00:45:58killing Americans and killing West Virginians,

00:46:00and bringing more things to do more.

00:46:03Well, let me just say, you know,

00:46:07my staff is available to yours

00:46:09and I think they are talking,

00:46:11and as frequently as possible in my view,

00:46:14we need a legal construct

00:46:15if we're gonna pull things off the market.

00:46:18We'll work with you on that.

00:46:20If you're telling me we have to do something,

00:46:21you need legislation here to pull things off the market

00:46:25once they've been approved

00:46:26and even if something's replacing, it's better?

00:46:28I really, you know, Senator,

00:46:31as I've aged in this job,

00:46:33I really believe-

00:46:34We're all aging right now.

00:46:35We at FDA are referees primarily.

00:46:38The rule book is written by Congress.

00:46:40So when you write a law, we follow the law.

00:46:43Fair enough.

00:46:44Let me mention one other,

00:46:45just you may be prepared to ask about this.

00:46:49The issue of, you know,

00:46:51personally I'm very much in favor

00:46:53of something you've advocated for,

00:46:54which is for a new opioid to come on the market

00:46:57as opposed to all other drugs and classes of drugs.

00:47:02It ought to have an advantage over what's,

00:47:04we don't need more opioids on the market.

00:47:06I think we agree on that.

00:47:07Yes, we do.

00:47:08Unless there's something

00:47:08that's really a significant advantage.

00:47:11But right now, the rule book that we referee upon

00:47:16says if the drug is better for the indication than nothing,

00:47:20then it's allowed on the market.

00:47:24So you need language basically saying,

00:47:26is it an improved drug that'll perform better

00:47:30than the existing drug?

00:47:31So we'll remove the existing drug.

00:47:32That's right.

00:47:33Okay, got it.

00:47:34Thank you, Senator.

00:47:36We're gonna do a quick second round.

00:47:37So if you wanna stick around,

00:47:39we can have some more conversation about this.

00:47:42Doctor, I don't wanna put you in a situation

00:47:46with regard to the Supreme Court decision,

00:47:48but I do wanna ask you just patently,

00:47:50is Mifeprostone safe?

00:47:53I, you know, I'm on the record multiple times about this.

00:47:58We stand by the decisions of the FDA over the years

00:48:01and the constant looking at the surveillance data

00:48:03and clinical trials as they come in.

00:48:06Mifeprostone is safe and effective for its indication

00:48:10and we stand by that.

00:48:12Thank you.

00:48:14Talk to me about vaccine development and HPAI.

00:48:18And I know your role is to approve vaccines,

00:48:21but where are we in that process?

00:48:24And if we do have a zoonotic transmission to humans,

00:48:28you know, what is our posture and are we ready for that?

00:48:33I'd say we're ready.

00:48:36You'll notice that part of the budget

00:48:38as sort of separate from the rest of the budget

00:48:40is a pandemic preparedness part of the budget.

00:48:44The way I look at it,

00:48:45we are in an enviable position

00:48:47compared to any time in the history of the world.

00:48:50Senator Hoeven made,

00:48:51rhetorically I think made the point

00:48:53that pandemics have always been around.

00:48:56It's just that now because they used to be limited

00:48:58by the fact people didn't travel,

00:49:00now we're on airplanes and as we saw with COVID,

00:49:03it moves quickly from one place to another.

00:49:07The enviable position we're in now

00:49:08is we have mRNA templates that are platforms

00:49:12that we have confidence in already

00:49:14where what used to be a mystery,

00:49:17how do you make a vaccine by the old method

00:49:20that would take many months,

00:49:22now we can do it in just a few weeks to a couple of months,

00:49:27but we gotta have the funding to keep the source warm

00:49:33so that we can start up right away.

00:49:36And that's part of what's-

00:49:37And that mRNA platform is applicable in this case?

00:49:41Yes, sir.

00:49:42Great.

00:49:43And you know, it's a great thing for many of the,

00:49:45viruses are relatively simple

00:49:47compared to other kinds of organisms,

00:49:48so coming up with a matching vaccine

00:49:51for the exact genetic makeup of the virus

00:49:54is entirely possible in a very short period of time.

00:49:58So it's another place,

00:50:00I didn't mention the NIH before as a critical player here.

00:50:03The NIH is doing a lot of the background work

00:50:06to characterize the virus with its excellent virologists

00:50:10so that we can be ready working with the industry

00:50:14that makes the vaccines.

00:50:17Talk to me a little bit about vaping.

00:50:19Why are we not making faster progress

00:50:23on the incredible number of unapproved vaping products

00:50:27that are on the market?

00:50:29If you'll bear with me for just a minute,

00:50:31I'd like to sort of go through my thinking on this

00:50:33because I'm as frustrated as you are with it.

00:50:37I have to live with it every day

00:50:38and I have relatives that are addicted to nicotine.

00:50:41I'm from South Carolina and practice medicine

00:50:45in maybe the seat of the tobacco industry

00:50:49in the past in Durham.

00:50:52So first of all, I do want to point out

00:50:54that we're making progress in combustible tobacco,

00:50:57although we're still gonna lose

00:50:58almost 500,000 Americans this year

00:51:01to tobacco-related illness.

00:51:03That and hypertension are the two biggest

00:51:04remediable causes of death that we're dealing with.

00:51:09But just as we're making that kind of progress

00:51:11with combustible tobacco, along came vaping.

00:51:14It was 2016 during my first term that we deemed vaping,

00:51:17but we had no idea it was gonna result

00:51:20in 26 million applications for vaping products

00:51:25that happened while I was away at Alphabet.

00:51:30And I came back to find the Center for Tobacco Products

00:51:33full of good, hardworking people,

00:51:35but an overwhelming number of applications

00:51:38from an industry.

00:51:39I was in Silicon Valley, I must say.

00:51:42The combination of an addictive substance called nicotine

00:51:46with marketing done through Silicon Valley techniques

00:51:49was overwhelming.

00:51:52We had a Reagan-Udall report.

00:51:56We have a new head of the Center

00:51:57for Tobacco Products, Brian King,

00:51:59and we've made tremendous progress in this regard.

00:52:03But just as we're getting a handle on the basics of vaping,

00:52:07and by the way, at least by the surveys,

00:52:10a number of teenagers vaping did decline last year,

00:52:13but it's nowhere where it needs to be.

00:52:15Just as we're making that progress,

00:52:17along comes the Chinese manufacturing of vaping products.

00:52:21And the overwhelming vaping products

00:52:23now used by American youth and getting addicted

00:52:26is made in China.

00:52:28So can I go one more minute on this?

00:52:31Please.

00:52:33Here we have products that are not legal

00:52:35to sell to Chinese people in China,

00:52:37made in China and imported into the United States

00:52:40in large numbers.

00:52:41Now, the old regime of dealing with this,

00:52:46one of you had mentioned several hundred thousand

00:52:48establishments, it's actually a million,

00:52:51because we have 300,000 retail stores

00:52:53selling vaping products in the United States.

00:52:56If we take our 1,400 investigators,

00:53:00i.e. inspectors, and try to have them manage

00:53:03300,000 vaping establishments,

00:53:06that's, math doesn't work.

00:53:09So we gotta stop this at the point of import.

00:53:12So we're actively working now with the,

00:53:15you talk about multiple agencies,

00:53:17Justice Department, remember, we can't enforce

00:53:21without the Justice Department agreement

00:53:23if we have to go to court on these issues.

00:53:26And CBP, the border force, is very important here.

00:53:33So I wanna work with you all to come up with a way,

00:53:36and you would be amazed if you saw

00:53:39what we have to go through to take action

00:53:43with one product coming into

00:53:44the international mail facility.

00:53:46It's a very complicated legal proceeding,

00:53:49because every company has a right to defend itself

00:53:53in court from actions that we take.

00:53:56I think the circumstance here where you have a product

00:53:59that China won't sell to its own people

00:54:02being imported into the United States to addict youth,

00:54:06we oughta be able to come up with a way

00:54:07to say it's pretty simple.

00:54:09When it comes in, destroy it.

00:54:12And CBP, by the way, can recover the money

00:54:17from the importer for an illegal product.

00:54:20This is an authority that we don't have at the FDA.

00:54:23So we're actively working on that mix.

00:54:26I don't blame you for being.

00:54:27If you need additional authorities from Congress,

00:54:29or additional direction to make sure

00:54:32that we're addressing this in a more efficient way,

00:54:35I think you would find a very receptive audience.

00:54:39I wish I could tell you exactly what it is now,

00:54:41but it will be very shortly.

00:54:43We'll have a composite view from the Justice Department,

00:54:47the FDA, and Border Patrol about

00:54:50what would be most effective.

00:54:52I wanna just cut it off, just not even let it in.

00:54:54Then we can deal with the vaping industry

00:54:56in the United States, which has many additional issues,

00:54:59but at least we could deal with that.

00:55:01Okay.

00:55:02Senator Murray.

00:55:04Mr. Chairman, thank you very much,

00:55:06and thank you, Commissioner Califf.

00:55:07Good to see you again.

00:55:09As I always say every time families

00:55:11head out to the grocery store or sit down for a meal,

00:55:14they're putting their trust in the FDA.

00:55:17The health and safety of our nation

00:55:18depend on the world-class experts at FDA

00:55:21who work diligently to protect our food supply,

00:55:24address threats like shortages or contaminants,

00:55:27and a lot more.

00:55:28The stakes are always high,

00:55:30as we saw during the infant formula crisis,

00:55:32something I wanna see FDA to do more to learn from,

00:55:37because no parent should ever worry

00:55:39about whether the formula that they feed their baby is safe.

00:55:42So I'm glad we have this opportunity

00:55:44to talk about the resources your agency needs

00:55:47to fulfill its really important mission.

00:55:50Before I start my questions, I also wanna say one thing

00:55:52I think we both agree on, agree your agency does not need,

00:55:57and that is political interference

00:55:59in FDA's science-driven decision-making processes.

00:56:03We've seen a number of baseless claims and disinformation

00:56:06from anti-abortion activists and some Republican lawmakers,

00:56:10which are really threatening to undermine

00:56:12FDA's credibility and its authority.

00:56:14So let me set the record straight, and Dr. Califf,

00:56:17I hope you will continue to as well.

00:56:20Mifepristone is safe, it is effective,

00:56:23and that's just not me saying that.

00:56:24It is scientists, experts, and decades, decades of data.

00:56:29Republican politicians should not be overruling experts

00:56:33on science or overruling women

00:56:35about their own healthcare decisions.

00:56:38And at a time when women across the country

00:56:40are facing rampant attacks on abortion access,

00:56:43this dangerous disinformation is an attack we all can

00:56:46and all should be fighting loudly and clearly.

00:56:50I just wanted that on the record, so thank you, Mr. Chairman.

00:56:54Dr. Califf, you, before I got here,

00:56:56talked about H5N1 avian flu.

00:56:59This is something that Senator Burr and I put together,

00:57:02the Office of Pandemic Preparedness and Response Policy,

00:57:06and we got funding for it in the last bill.

00:57:08Can you talk a little bit about how your agency

00:57:11is coordinating with OPPR and other federal agencies?

00:57:15Yes, as we discussed just a few minutes ago,

00:57:19OPPR has been the central coordinator

00:57:22of the effort across agencies that, you know,

00:57:26have boundaries that have to be overcome to work together,

00:57:29so the Agriculture Department

00:57:31is in an entirely different sphere than FDA and CDC,

00:57:34which are within HHS, so there's a daily call,

00:57:38I'm actually missing it today for this hearing,

00:57:41of the leaders and the top leaders,

00:57:45in addition to the key people who carry out the operations,

00:57:49where what happened the day before is reviewed,

00:57:53what needs to be done that day is reviewed,

00:57:55and the long-term plans are made,

00:57:57so I'm glad that you put together the plan.

00:58:02I just hope that the funding is adequate in the future,

00:58:07because, as Senator Hoeven pointed out,

00:58:10we're gonna continue to have outbreaks and pandemics

00:58:14for the foreseeable future.

00:58:16Thank you.

00:58:18On cosmetics reform, I was really glad

00:58:20that we provided $7 million for the implementation

00:58:24of the Modernization of Cosmetics Regulation Act of 2022

00:58:28that I negotiated and got signed into law.

00:58:31That bill, for the first time,

00:58:32provided much-needed new authority to FDA

00:58:35to make sure that families know

00:58:37the products we put on our bodies every day are safe.

00:58:40I wanted to ask you today what steps the agency

00:58:42has taken over the last year

00:58:44to implement those new authorities,

00:58:46and what resources are requested

00:58:48in your budget for this year.

00:58:51Well, first of all, thanks for doing that.

00:58:52I think it was decades of trying

00:58:55before this finally happened,

00:58:57and people tend to think of cosmetics

00:58:58as just something you put on your skin for looks,

00:59:01but the skin, you know, the quiz of the day,

00:59:04the skin is the largest organ in the human body,

00:59:07and it absorbs what's put on it,

00:59:10and so there's good reason to at least know

00:59:13what's in the cosmetics that you're using.

00:59:18You know, I'm pleased to say we made a decision

00:59:20to put cosmetics in the Office of the Chief Scientist

00:59:23under the purview of Dr. Numanjay Bampus,

00:59:26who's our Chief Scientist, who, by the way,

00:59:29I just was pleased to elevate to Principal Deputy.

00:59:33She's done such a great job.

00:59:36Progress we've made really exceeded what we had planned,

00:59:39that is, for the first year,

00:59:41which is that we now have the listing,

00:59:42so there's a place for the cosmetics companies

00:59:46to list that they're on the market and what's in them,

00:59:50and there's also an adverse event reporting system

00:59:52for the first time.

00:59:53We were able to capitalize on CDER's

00:59:56drug adverse reporting system to put one in quickly.

01:00:00We've definitely, this is done on a shoestring,

01:00:03and we've, in the budget, we have an $8 million

01:00:05asked to really instantiate this office

01:00:09and get to the next level.

01:00:12As you also know, there's several cosmetics

01:00:14that are very worrisome in terms of health,

01:00:16where we have to do a lot of work

01:00:18in order to take the kind of actions

01:00:21that are needed to protect health,

01:00:23and we need a budget to make sure those things can be done.

01:00:29Thank you, and this is something really important to me,

01:00:31so I appreciate the work this committee did on that.

01:00:35I understand that the proposed

01:00:37Unified Human Foods Program continues to make its way

01:00:40through the administrative process.

01:00:42It's been well-documented that these reforms are overdue.

01:00:46FDA's regulation and enforcement of food safety standards

01:00:49on issues ranging from bacteria and vegetables

01:00:52to arsenic and baby food are really critical.

01:00:55What is your agency requesting in FY25

01:00:58for implementation of the reorganization?

01:01:02Well, in this budget, we're asking

01:01:04for an additional $15 million,

01:01:06and I honestly regard that as a hope for a down payment.

01:01:12I think you'll, if you go to the Reagan-Udall report,

01:01:14you'll see beautiful graphs,

01:01:17although they're somewhat depressing,

01:01:19of the funding of the drug

01:01:21and the medical product side of the FDA.

01:01:25Thanks to the user fees, it's meeting the mark.

01:01:30It could always be better,

01:01:31but the food side of the FDA has been increased,

01:01:36but well below even the cost of living,

01:01:39inflationary increase at a time

01:01:42when the foods industry is increasingly complex,

01:01:45global, interdigitated, with many issues.

01:01:51So part of what we're doing in the RE-ORG

01:01:54is to create a budget where you can really see

01:01:57exactly what the money's being spent on.

01:01:59I recognize when I came in, when I asked for the budget,

01:02:03on the medical product side, it was really clear

01:02:05because the user fees institute a business-like process,

01:02:09whereas on the food side, there was a lot of intermixing

01:02:12in ways that were harder to depict.

01:02:15I think when you all see the places where it's needed,

01:02:19and I'll just point to two examples

01:02:21that I think are really critical.

01:02:23We all know that we're in a global environment

01:02:26where more and more things are getting into the food

01:02:28in the way of chemicals.

01:02:30We chose Jim Jones to be our leader

01:02:33of the Human Foods Program.

01:02:34He has a history in the EPA

01:02:36of dealing with chemical contamination.

01:02:40We had basically a tiny little crew of people

01:02:42working on that on the food side of the FDA.

01:02:46So as you see what's at stake and what needs to be done,

01:02:50I hope that will make clear what funding is needed

01:02:54and also give you a way to make sure when you invest money

01:02:57that you can actually see what's being done.

01:03:00The other one that's enormous is nutrition.

01:03:02We talk about three pillars of risk,

01:03:05obviously microbial, which everyone understands,

01:03:08chemicals, which are a great concern,

01:03:11but our biggest cause of death and disability from food

01:03:14is actually bad nutrition.

01:03:17And we've got this tremendous epidemic of obesity,

01:03:21diabetes, cardiovascular disease,

01:03:24and cancer emanating from all that

01:03:27in a setting in which our tools on the nutrition side

01:03:30are very limited.

01:03:32So we're gonna have a Center of Excellence in Nutrition

01:03:35nested in that is gonna be the critical foods group

01:03:39that was mandated in Fedora

01:03:42that will deal with infant formula and medical foods.

01:03:46So hopefully this will all clarify

01:03:48where the money's actually gonna be useful

01:03:49as opposed to just asking for money

01:03:51based on a broad concept.

01:03:54Okay, thank you very much.

01:03:56And Mr. Chairman, thank you for the explanation.

01:03:58Thank you, Member Hoeven.

01:03:59Thanks, Mr. Chairman.

01:04:01So Senator Pewters and I are working on some legislation

01:04:05in regard to infant formula.

01:04:07He's really coming at it from the safety end.

01:04:09I'm coming at it from adequacy.

01:04:10So we wanna make sure it's helpful to you,

01:04:12doesn't impose costs and restrictions

01:04:14that would be counterproductive.

01:04:15Do you have any specific thoughts in regard to that?

01:04:25The safety side is pretty straightforward, as you know,

01:04:28and there's just some things that we need.

01:04:30And again, just to reemphasize,

01:04:33as I learned in my high school reunion,

01:04:35people think the FDA has magical powers

01:04:37to just march in and force people to do it.

01:04:39And at the reunion, you told them, in fact, you did.

01:04:42No, I was asking for sympathy, actually.

01:04:46But so the safety side is,

01:04:50we just need a few more things

01:04:51that would require that first line of defense

01:04:53that we always depend on,

01:04:54which is the industry doing what it should do

01:04:57and our checking to make sure

01:04:58they're doing what they should do.

01:05:01On the adequacy part, it is really complicated.

01:05:05And I would just say, I look forward to working with you.

01:05:08I have ideas.

01:05:11It's very complicated by the WIC program

01:05:13and the way the states purchase the formula.

01:05:17Many of us believe that the industry

01:05:19is too concentrated in a few companies.

01:05:21But it also turns out, if you look globally,

01:05:24in every country, there are just a couple

01:05:26of companies that dominate in each company.

01:05:30And we have programs now to entice people into the market,

01:05:36but if half the market in every state is WIC,

01:05:39it's very hard for new entrants to actually get a foothold

01:05:41and have enough sales.

01:05:43So these are daunting problems,

01:05:45and we would love to work with you.

01:05:47It's not our primary responsibility,

01:05:49but we obviously have opinions,

01:05:51and it affects us when it's not working.

01:05:54Right, that's what we want to do.

01:05:56Drug shortages.

01:05:57In your opinion, what's the greatest challenges

01:05:59you face in this space, and how can we improve that?

01:06:06The answer's kind of similar, but let me break it in half.

01:06:08We have a set of things that I regard

01:06:11as the whole plugging activities.

01:06:12That's our primary issue there.

01:06:15And we know of an impending shortage,

01:06:18and there are over 200 per year happening now.

01:06:21We have a set of maneuvers we can do

01:06:23that are much like you would do if you were in a town

01:06:26and the grocery store was going out of business,

01:06:29you need to find another grocery store.

01:06:30We get on the phone, we go to all resources

01:06:34to find alternatives, either to produce the same product

01:06:37or a drug that is equivalent.

01:06:41And we need some help there from you all

01:06:44in filling in the holes in our knowledge base

01:06:47that would enable us to put together

01:06:49what we need to plug the holes much more efficiently.

01:06:53And we've asked for an additional $12 million

01:06:56in the budget for analysts and people to basically

01:07:01anticipate when shortages may occur so we can preempt.

01:07:05We're successful in preempting

01:07:06about 80 to 90% of the shortages,

01:07:09but we still have too many that are occurring.

01:07:12But part two is actually the big deal,

01:07:13and it's very much like what I said about the formula.

01:07:16We have a market failure,

01:07:18and it's very hard just to quickly go through this.

01:07:21It's really important to understand

01:07:23that we have two industries essentially,

01:07:25with some overlap,

01:07:26but two industries in the pharmaceutical arena.

01:07:30The innovator industries make patented drugs

01:07:33which have protection from patents from competition.

01:07:38I don't believe the price is too high there.

01:07:40I know there are different opinions about that,

01:07:42but let's just say that the profits are good

01:07:45and there's every incentive for the companies

01:07:47to make every drug they can sell

01:07:50because they make money.

01:07:53The 95% of our prescriptions now are generic drugs,

01:07:58and they're essentially copies of the innovator drug

01:08:01after the patent is over.

01:08:02It's a simple way to think about it.

01:08:04The prices there are too low.

01:08:06Our generic prices are actually lower than Canada

01:08:09and Europe.

01:08:10And so the shortages we're seeing,

01:08:13the probability of a shortage is directly related

01:08:16to how low the price is.

01:08:17Now, I'm a capitalist American.

01:08:21Just put yourself in the shoes of a CEO

01:08:24and say you can either make a drug

01:08:26that's gonna make a big profit for your company,

01:08:28or you can make a drug where you're guaranteed

01:08:30to lose money because the price is too low.

01:08:33Which one are you gonna do?

01:08:34So the companies, even in India,

01:08:37where the cost of labor is so low,

01:08:39they're telling us they can't make

01:08:41and distribute the product at the price they're getting.

01:08:46And in the middle of all this in America,

01:08:50of course, is the metal man, the GPOs and PBMs,

01:08:54which I know you all have been talking about.

01:08:57They're not regulated by anybody right now, basically,

01:09:00and this is an area where work needs to be done.

01:09:03It's not my job to say exactly what should be done.

01:09:06Of course I have ideas, like I do, about infant formula.

01:09:10But unless we fix the market failure,

01:09:13we at FDA are gonna be expending more and more energy

01:09:17just plugging holes in the system

01:09:18that we could have predicted were gonna happen

01:09:21in the first place.

01:09:22But we can't tell anyone to make a drug.

01:09:24We don't make the drugs ourselves.

01:09:27So we're just trying to line up the people

01:09:29that do make them in a way that can be successful.

01:09:32I wanna follow up with you on that disparity

01:09:36in terms of the pricing between the new name brand,

01:09:41patent protected drug, and the generic.

01:09:44I had not heard that point on the generic before,

01:09:47so that's interesting.

01:09:48I think it's something we'll try to follow up with you

01:09:50and understand better.

01:09:52But I think the drug shortage is important.

01:09:54We wanna find ways to address it

01:09:58that are actually effective for consumers

01:10:00and don't create market distortions or burdens.

01:10:03If I may, I'd refer you to an HHS report

01:10:06that came out just a few weeks ago

01:10:08that goes through this in great detail.

01:10:11I think if your staff reads it,

01:10:14they probably already have, but get a briefing on it

01:10:16because I think it'll give you a lot of insight

01:10:19into what's happening here.

01:10:22And I'm personally traveling over to India

01:10:25because we're very dependent now

01:10:27on foreign manufacturing of these products

01:10:31because there's not enough.

01:10:34Which is a concern as well.

01:10:35Yeah, it should be.

01:10:37Thank you.

01:10:38Senator Manchin.

01:10:39Very carefully, very quickly on that.

01:10:42Do we produce any antibiotics here in America?

01:10:46Someone told me strep throat could take us down.

01:10:48Not many.

01:10:52Does the alarm been raised why we should have

01:10:54some manufacturing producing the necessities for us

01:10:58just off the basic?

01:11:00I feel like from the day I came into this job this time,

01:11:03I have been screaming and shouting from the rooftops.

01:11:06But I mean, as you know, Senator,

01:11:08you've had family in the generic drug business.

01:11:13They were told, well, they had to close down the plant

01:11:14because they had too many drugs they were producing.

01:11:16Right, I mean, your cost of labor in West Virginia

01:11:19is competitive, I'll just say,

01:11:22and yet you still couldn't keep that going.

01:11:25And so...

01:11:27They were taken down because of FDA.

01:11:30Back then, it just made them impossible

01:11:33because they had so many drugs they were producing.

01:11:34They were producing those by the billions.

01:11:37We don't do any of that anymore.

01:11:38I just think it's a horrible situation.

01:11:41And I've talked to Secretary Becerra about this

01:11:46and basically getting, we have manufacturers

01:11:48who want to get back in business,

01:11:50making that and stockpiling it

01:11:51so we do have it here in America made.

01:11:53The other thing I want to mention to you,

01:11:55on December 22nd and 22,

01:11:57which was basically the fiscal year 2023

01:12:00omnibus bill that we passed,

01:12:03it included my freed of Opioids Act,

01:12:05which requires FDA to review

01:12:08how they approve new opiate drugs.

01:12:10So that is in the law, okay?

01:12:13Now, also, May 26th at that same time,

01:12:16and right now it's a support act,

01:12:18it passed the HELP Committee.

01:12:20And the support act, I think, does what you want.

01:12:22It was myself, Senator Braun.

01:12:24It's ensuring the FDA fully examines

01:12:27clinical trial impact and vitalness

01:12:29before endorsement act, which is the EFFECT Act,

01:12:32which would allow the Food and Drug Administration

01:12:34to deny a new drug application

01:12:36for an opiate analgesic drug

01:12:39on the basis of the drugs not being clinically superior

01:12:43to other commercially available drugs.

01:12:45Would that help?

01:12:46That bill, I mean, that bill's gone through the gambit.

01:12:49We just got to attach it to something right now.

01:12:52Yeah, we'll have to get with your staff.

01:12:55There are always details in these things.

01:12:57Well, Audrey will be happy to reach out.

01:12:59The basic concept is, you know,

01:13:02this is an exception to the rule for opiates,

01:13:06but I think the destruction and deaths

01:13:09that you've talked about merit it in this case.

01:13:11Sir, what's happening is, I mean,

01:13:13I understand the lobbying force up here,

01:13:15you know, and Big Pharma and all that,

01:13:18but the bottom line is, is there's a lot of drugs

01:13:20we depend on, and I support them 1,000%.

01:13:23This is one, I never grew up with it.

01:13:25I never had, these things weren't on the market

01:13:27when I was a kid.

01:13:28I got taken care of pretty good.

01:13:30When I was in the hospital, if I ever went to the hospital,

01:13:32they took care of me when I needed.

01:13:33When I got out of the hospital, I couldn't get,

01:13:34if I still liked what they gave me in the hospital,

01:13:36I couldn't get anywhere else.

01:13:37So all of a sudden, we know the history on that one,

01:13:41but we have a couple of things here

01:13:42we would like to work with you on.

01:13:44I think that you might have some powers already,

01:13:46and we're trying to give you more.

01:13:48Let's make sure this other one's done the right way.

01:13:50Okay, thank you, sir.

01:13:52Senator Hyde-Smith.

01:13:54Thank you, Mr. Chairman.

01:13:57The gulf shrimp industry is very important

01:14:02to Mississippi, Dr. Califf.

01:14:05And right now, because of bad actors in other countries,

01:14:09Mississippi shrimpers and processors

01:14:11don't know if they're going to survive another season.

01:14:15And this is a real situation.

01:14:18I was on the coast, not before last, in Mississippi.

01:14:23And the primary reason for this

01:14:25is that many foreign countries

01:14:26unfairly subsidize shrimp production

01:14:30and dump shrimp onto the market

01:14:32at prices that domestic producers can't compete with

01:14:35because we do not subsidize.

01:14:38Ecuador is one of the primary bad actors,

01:14:41and shrimp imports from Ecuador are growing faster

01:14:44than imports from any other country.

01:14:47It's also important for inspection of imported shrimp

01:14:51to be robust, especially during times like these

01:14:54when gulf shrimpers are struggling so much

01:14:57with unfair trade practices.

01:14:59I was happy to see that in August 2023,

01:15:02FDA signed a regulatory partnership agreement with Ecuador

01:15:06to strengthen food safety in shrimp

01:15:08intended for the U.S. market.

01:15:10This is important both for public health

01:15:13and for the future of our domestic shrimp industry.

01:15:17Domestic shrimpers should not have to compete

01:15:19with unfair trade practices,

01:15:20but they should especially not have to compete

01:15:23with shrimp riddled with illegal

01:15:24or dangerous chemicals and drugs.

01:15:27What percentage of imports from Ecuador

01:15:30has FDA inspected since this arrangement was signed,

01:15:33and have any imports been refused to your knowledge?

01:15:40Sorry, I'd have to get back with you on these exact numbers,

01:15:43but I sure agree with you that, first of all,

01:15:47you all gave us additional funding

01:15:50to implement programs like this.

01:15:54We have to keep foreign imports to the same standards

01:15:56that we have in the U.S.,

01:15:58and the more we can get these countries

01:16:00to do a good job on their own,

01:16:03the better off we're gonna be in terms of using

01:16:06our resources to double-check and make sure things are okay.

01:16:10So the agreement with Ecuador is the first of three

01:16:13that we hope to have.

01:16:15The other two big importers are India and Indonesia.

01:16:19Very similar issues there.

01:16:21You're right, over 90% of our shrimp

01:16:24that we eat now is imported.

01:16:26Personally, when I eat shrimp and grits,

01:16:28as we discussed last year, it's South Carolina

01:16:32or North Carolina shrimp are my preference,

01:16:34but I put Louisiana and Mississippi right up there, too,

01:16:38and I agree with everything you said

01:16:40about needing to fortify the industry here.

01:16:44As you well know, we don't,

01:16:47our remit is not within the economics of the industry.

01:16:50We have to regulate whatever the economics are dictating,

01:16:54but we do have this obligation that you refer to

01:16:57to keep the chemicals out,

01:16:59but we'll get back to you with the details

01:17:04of the number of inspections and what's been done

01:17:06in the way of detecting things

01:17:08and preventing them from getting into the country

01:17:11if they're not up to snuff.

01:17:14Thank you, that would be very much appreciated.

01:17:16Thank you, Mr. Chairman.

01:17:18I want to thank you, Commissioner Califf,

01:17:20for being here today,

01:17:21and I look forward to working with you

01:17:23and the members of this committee

01:17:25as we work through this year's appropriations process.

01:17:29For members, questions for the record

01:17:31are due by next Wednesday, the 15th of May,

01:17:34and we'd appreciate responses back from FDA within 30 days.

01:17:39And with that, this hearing is adjourned.

01:17:47Thank you.

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