▶ 0:25:28Chair Cassidy: The senate committee on health, education, labor, and pensions will please come to order. I think at least one person wants to make a statement regarding this. After we go through this we well. I appreciate Mr. sonderling for appearing before the committee last week.
▶ 0:25:51Chair Cassidy: If confirmed as deputy secretary of labor, he will enact trump's agenda empowering workers and creating economic growth worldwide. Nationwide. His expertise and experience in labor policy makes him more than qualified. Mr. sonderling committed to support workers, allowing them to earn a living and provide for their families in a manner they choose.
▶ 0:26:17Chair Cassidy: He was instrumental in creating the independent contractor standard in the first trump administration. I hope the department of labor will return to this policy. He also committed to clarify regulations so workers are protected, and employers have legal clarity on what does and does not violate federal labor law. Alongside the secretary designate, Mr. sonderling is ready to work with this committee to implement a pro-american agenda that secures a better future for all workers.
▶ 0:26:49Chair Cassidy: I proudly support his nomination and urge my colleagues to do the same. With that, I recognize senator sanders for his opening statement.
▶ 0:26:58Sen. Sanders: Thank, Mr. chairman, for a wide variety of reasons. I strongly oppose president trump's deputy secretary of labor nominee, keith sonderling. More importantly than my views on Mr. sonderling is the reality that it really does not matter who becomes deputy labor secretary.
▶ 0:27:21Sen. Sanders: In a few moments, we will be hearing from president trump's nominee to be the next commissioner of the food and drug administration, martin makary. Truthfully, and with respect to Dr. makary, it does not matter who the next fda commissioner is . I think everybody on this committee and the people of america understand who is running the government, and it's not going to be the secretary of labor. It's not going to be the secretary of the food and drug administration.
▶ 0:27:52Sen. Sanders: With all due respect to president trump's nominees, the people who -- the person who is running the government right now is elon musk. Mr. musk has taken upon himself to support -- with the support of president trump to virtually dismantle the united states government. Yesterday, shockingly -- as a former chairman of the veterans committee, it is outrageous beyond belief.
▶ 0:28:23Sen. Sanders: Veterans put their lives on the line to defend our country. Yesterday, we heard that 80,000 employees at the v.a. Are going to be terminated. Virtually all americans understand how important social security is to the well-being of our seniors. Yesterday, we learned they are on their way to get rid of half of social security employees, at a time when social security is now grossly understaffed. Mr.
▶ 0:28:52Sen. Sanders: Musk has ordered hhs, the department of labor, and the department of education to fire employees, and over confidential and sensitive data, and defy judicial orders. Mr. chairman, if we are serious about exercising our constitutional responsibilities, which I hope all of us are, it is critical for our committee to hear from the person who is in fact in charge of the federal government.
▶ 0:29:23Sen. Sanders: Yesterday, it was reported that Mr. musk met with republican senators, a private meeting for 90 minutes, and plans to do the same with republican members of the house. That is fine. The washington post reported Mr. musk gave his cell phone number two republican senators, and promised to approve with congressional republicans. That's fine. You know what?
▶ 0:29:47Sen. Sanders: My constituents in vermont and constituents all over this country wonder what the hell is going on with the federal government right now. It is not going to be the assistant secretary of labor who is going to tell them. So if we are serious, Mr. chairman, about our oversight responsible -- responsibilities, we must find out what is going on in the federal government. We do that is bringing Mr. musk before this committee. Therefore, Mr. chairman, I would like to make a motion.
▶ 0:30:16Sen. Sanders: I move that pursuant to its authority under rules 25 and 26 of the standing rules of the senate, and rule 17 of the rules of procedure of the united states senate committee on health, education, labor, and pensions hereby authorizes and investigation into the actives -- actions of those services at agencies within the committee jurisdiction, and pursuant to the same authority authorizes the chairman to subpoena Mr. elon musk for testimony regarding those actions.
▶ 0:30:44Chair Cassidy: We are proceeding with the vote included on the published agenda for this executive session. Unrelated motions will not disrupt the vote that was properly noticed to the committee.
▶ 0:30:56Sen. Sanders: I move to overturn the ruling of the chair. This motion is out of order.
▶ 0:31:02Chair Cassidy: That is -- I'm sorry? We are staying with the published agenda. I will ask the chair, the ranking member, if he wishes to have something included on the published agenda, then bring it beforehand. But we are staying with the published agenda. The clerk will call the roll. >> Mr. chair?
▶ 0:31:36Chair Cassidy: Will we have the opportunity to speak about --
▶ 0:31:38Chair Cassidy: Yes, sir.
▶ 0:31:41Sen. Sanders: Mr. chair --
▶ 0:31:42Chair Cassidy: The clerk will call the roll on sonderling. >> senator paul? Senator collins? Senator murkowski? Senator mullin? Senator marshall? Senator scott? Senator hawley? Senator tuberville? Senator banks? Senator husted?
▶ 0:32:12Chair Cassidy: Senator moody? Senator sanders?
▶ 0:32:16Sen. Sanders: No.
▶ 0:32:19Senator Murray: No. >> senator murphy? Senator laom--- -- senator kaine? Senator hassan? Senator hickenlooper? Senator markey? Senator kim? Senator blunt rochester? Senator alsobrooks? Chairman cassidy? I have 12 ayes, 11 nays.
▶ 0:32:57Senator Murray: >> Mr. chairman, I approve this motion and I moved to adjourn.
▶ 0:33:02Chair Cassidy: I promise Mr. kaine, senator kaine, that he could testify. But I think we are through with the business. If people wish to leave no --
▶ 0:33:18Sen. Sanders: I second the motion, actually, to adjourn.
▶ 0:33:21Sen. Kaine: This is to colleagues. The vote is over. I want to share a concern. I'm going to ask if I can hand out a q f r answer that Mr. sonderling provided to the committee. I voted yes for the labor secretary. Some of you were here when I asked Mr. sonderling some questions. He is currently at the agency. He is the acting chief assistant to the acting secretary. He has been there since january 20.
▶ 0:33:50Sen. Kaine: I asked him the question, calmly people have you laid off in the apartment of labor, and how many of those -- he did not know off the top because he had not prepped for that question. But I asked who knows that, and he told me the department within the department of knows the human resources questions. He is in the acting secretary's office and clearly has interaction with that office. I asked him the qfr which is being distributed to you.
▶ 0:34:20Sen. Kaine: He did not know it sitting before me because he had not prepared. I asked a civil question. How many department of labor employees have been fired or placed on it ministry of leave since january 2020 five. How many of those were veterans of the united states military. This is a question within his purview in his current position. He was prepped for it by me asking him.
▶ 0:34:42Sen. Kaine: And then I gave him a qfr and he knows the answer to the question. He knows the people who will give him the answer. His answer, to me, was a very clear stiff arm of a committee request. The department of labor's office of assistant secretary for management is responsible for all human resources. I have full faith and confidence that the staff in this office is complying with all applicable laws while reviewing executive orders and opm guidance.
▶ 0:35:13Sen. Kaine: He would not answer the question even though this information is within his purview. I think it is unacceptable that on a basic, simple question like this, some buddy who was here for a nomination would not answer a question tendered by the committee. Number two, I believe he knows the answer to the question, but does not want to give me the information because he is embarrassed about what it would suggest. The last thing I would say is, why would he be embarrassed about it?
▶ 0:35:41Sen. Kaine: His testimony said very plainly that he cares about workforce protections for all employees. I asked if it included veterans who were working for the federal government. He said it did. I think the answer to this question, which was what public reporting has showed, is that veterans are the group that is most disproportionately harmed by the trump firings and terminations thus far.
▶ 0:36:10Sen. Kaine: 30% of the federal workforce is veteran. 3%. It is about 3% of the civilian workforce. In addition to the fact that 30% of the federal workforce is veteran, there is a decision to lay off probationary employees because they cannot fight back. They are disproportionately veterans. Member, probation is not you did something wrong. Probation is you are new.
▶ 0:36:38Sen. Kaine: New employees in the federal government tend to be young people or career soldiers. Every veteran who works for five or 10 or 25 years and then gets a job in the federal government, no matter how valuable their military service -- we have virginians with multiple deployments and purple hearts and all kinds of awards. When they come into federal civilian service, they are probationary.
▶ 0:37:02Sen. Kaine: This effort to willy-nilly lay folks off and focus on probationers has hit veterans harder than anybody else. The new york times has estimated what they can. Questions like this don't get answers by folks with the administration. Donald trump has fired at least 6000 veterans so far, and he is not done. He has fired more veterans than any president in the history of the united states in six weeks, and he is not done. It is just not acceptable.
▶ 0:37:31Sen. Kaine: If I had asked this question of somebody who was not at the agency, they would say I have not been confirmed and I'm not at the agency yet and cannot give you answers. I voted for the secretary of labor nominee and I was at least open to this nominee when he came before us. When he has information in his purview about something that not only I care about, at that I think other members would care about, and he refuses to provide it, suggesting he is deforming me and the committee, and he is probably embarrassed about what the numbers would show -- that is the reason I opposed him.
▶ 0:38:03Sen. Kaine: The vote is done, what I would hope that this question -- I would be able to get information on basic factual questions. Then caring about the veterans who disproportionately make up the federal workforce -- >> Mr. chairman, I make a motion to adjourn.
▶ 0:45:23Chair Cassidy: Thank you, Dr. makary, for appearing before the committee. The food and drunkenness ration is tasked with overseeing everything from drugs that treat billeting diseases to safeguards in the U.S. food supply. While usda has become a safeguard of public health, the agency faces challenges. Bureaucracy has led to delays in approving medicines and devices, stripping patient access to treatments that can be lifesaving.
▶ 0:45:53Chair Cassidy: The trump administration looks to cut red tape across the federal government. The agency should look at ways to address bottlenecks in the review process. This could include using artificial intelligence and other technologies to improve efficiency and accelerate drug discovery, while ensuring these products are safe for americans. Another topic of interest is food safety. Americans deserve to know the food they buy for their families is safe to eat.
▶ 0:46:20Chair Cassidy: One place we should start is examining the fda review process to ensure the safety of ingredients that go into foods. I know after makary is passionate about this issue. I look forward to working with him if he is confirmed. The american people's trust in our public health and science agencies and the products they regulate must be restored.
▶ 0:46:43Chair Cassidy: Public confidence in products like vaccines is especially important as we respond to measles outbreaks and fda considers recommendations for vaccines for flu strains ahead of the upcoming flu season. Dr. mccurry, with his experience as a surgeon, and an effective health policy community -- commune cater, and help our agencies rebuild trust with the american people. Thank you for discussing your vision on how to make america healthy again. Senator sanders is not here.
▶ 0:47:14Chair Cassidy: Dr. mccurry, we will go to you for your opening statement -- Dr. makary, we will go to you for your opening statement.
▶ 0:47:21Dr. Makary: Thank you, members of the committee. I am humbled to be before you hear. I would like to thank president trump for his confidence in nominating me to lead the food and drug administration. I am joined today by my wife, jessica, my sister, maria, a brother, mark, alexander jacoby, and my very sacrificial mother,
▶ 0:47:51Dr. Makary: And my career role model, my father. My father dedicated his life to the care of children with leukemia, lymphoma, hemophilia, sickle cell disease, and then turned his attention to adult hematology.
▶ 0:48:09Dr. Makary: His father, my grandfather, was a pharmacist in a poor ejection community, and believed in treating everybody equally, especially the most vulnerable among them, a philosophy I have tried to emulate in my career and research. Even from the african continent, my grandfather looked to the U.S. fda for trusted guidance.
▶ 0:48:31Dr. Makary: That is because the fda has a long history of using gold standard science to uphold public safety and help us, as clinicians, take care of patients when they come to us for help. As a kid, I vividly remember being in the grocery store in our small town with my dad, when somebody would stop him, wake out in tears, and give him a long hug after what I would learn to be a decades long battle with lymphoma. It happened a few times.
▶ 0:49:02Dr. Makary: Each time, it inspired me even more. 422 years now, I have had the privilege to walk into the johns hopkins hospital to live out that mission. Each morning, as I enter the front door, I pause and look at the nine foot statue of jesus that stands in the center of the hospital lobby. And I read the sacred text engraved at the base. Come to me, all ye who are heavy laden, and I will give you rest.
▶ 0:49:34Dr. Makary: I'm grateful to johns hopkins for allowing me to have a creative career, a dual-career as both a surgical oncologist and a health care public policy researcher. In addition to using fda approved devices and medications, my research, which has now spanned over 300 scientific peer-reviewed articles in the medical literature, has focused on what is actually making a difference in helping people, and how health care has become too fragmented, too cold, and to
▶ 0:50:06Dr. Makary: Corporate. My research and subsequent book on price gouging and predatory billing in health care lead to demanding more transparency in health care. President trump heard the plea and invited me to the white house in his first administration, to enact the first executive order to bring down hospital and drug prices through greater transparency.
▶ 0:50:31Dr. Makary: The reform was entirely bipartisan, just as president trump and secretary kennedy's call to make american healthy again, by finally addressing the root causes of our chronic epidemic, which has resonated with moms across the country regardless of their politics. A smarter fda that works for all americans should be a goal we should all agree on.
▶ 0:50:57Dr. Makary: As a scientist who has spent a career evaluating medical inventions, I believe in the scientific process. In addition, I also believe we can use common sense. Dr.
▶ 0:51:10Dr. Makary: Cassidy, as I have been in the operating room, as you would relate as a respected him intelligence, it is hard to perform a long, sophisticated operation for liver cancer, and not ask why our rates of liver cancer triple in the united states. We now have a generational opportunity. President trump and secretary kennedy's focus on healthy foods has galvanized a grassroots movement in america.
▶ 0:51:40Dr. Makary: Childhood obesity is not a willpower problem, and the rise of early-onset alzheimer's is not a genetic cause. We should be and will be addressing food as it impacts our health.
▶ 0:51:54Dr. Makary: Thanks to the courage of president trump secretary kennedy, we now have a generational opportunity to usher in radical transparency, to facilitate marchers, meaningful treatments, and help people take care of their health. My father told me to write down my observations and experiences in health care in the research I ducked into. Much of the research I did focused on the fundamental question -- is what we are doing working?
▶ 0:52:24Dr. Makary: I wrote books to educate the public on medical science, and to empower them to live healthier lives. I look to ensure the fda holds to the gold standard of transparency and common sense to rebuild public trust and make america healthy again. Thank you, Mr. chairman.
▶ 0:52:46Chair Cassidy: Thank you, Dr. mccurry. -- makary. In 2021, a few months after president biden took office, the fda announced it would no longer enforce the in person dispensary requirement for mifepristone, the drug which is an abortifacient. This is concerning to me.
▶ 0:53:10Chair Cassidy: There is a case out of louisiana which is incredibly egregious in which there was no recognition that the person requesting the drug was not the patient, but rather someone who was going to allegedly coerce the person into taking the medication. Which would have been evident to a physician, should she or he have seen the patient.
▶ 0:53:31Chair Cassidy: If confirmed, would you reinstate the in person dispensary requirement, as well as reporting requirements for adverse events and other complications associated with the drug?
▶ 0:53:40Dr. Makary: Thank you, senator. To hear of someone being coerced to take mifepristone is deeply disturbing. I might even suggest criminal. I have no preconceived plans on mifepristone policy except to take a solid look at the data, and to meet with the professional career scientists who have reviewed the data and to build an expert coalition to review the ongoing data, which
▶ 0:54:11Dr. Makary: Is required to be collected as a part of the risk evaluation and medication strategy program. So we are going to collect data. I believe we should look at it.
▶ 0:54:22Chair Cassidy: Last week, the fda announced it would cancel its annual vaccines and related biologic product advisory committee, which meets to select anticipated virus strains for next year's flu vaccines. Now, I am told by people who are familiar that the fda will make the recommendation, and they will come up with the right decision.
▶ 0:54:47Chair Cassidy: But they also say what is lost is the transparency, because the open meeting allows a postmortem, if you will, as we say in medicine, a review of last year, what went right, what went wrong, and how to make it better. I think one of the laudable things about secretary kennedy's positions is he wants more transparency in terms of how the federal government makes medical decisions as part of restoring that faith. Prickly, this seems to go kind of backwards on that.
▶ 0:55:18Chair Cassidy: How will you ensure that advisory committees remain objective, transparent, and still benefiting from the necessary expertise of external experts?
▶ 0:55:27Dr. Makary: Senator, thank you for the question. I was not involved in that decision. Certainly, if confirmed, once in office, you have my commitment to take a look at it. As you know, that committee takes a look at guidance and recommendations from international groups, such as the gip international consortium.
▶ 0:55:54Dr. Makary: My understanding is at least for the last seven or eight years that I have been following that group, we have simply rubberstamped whatever the national --
▶ 0:56:05Chair Cassidy: My understanding goes that since these strains typically begin in australia or china, it is not so much a rubberstamp as recognizing what are you seeing, because that is what is coming to us. I think it is more than quibbling to say that you are learning from them.
▶ 0:56:28Dr. Makary: The american public deserves confidence that scientists are looking at the data from the southern hemisphere. It is all reported into a registry of dominant strains, and picking the dominant strains is the process of really trying to estimate which strains could be dominant in the united states. Some years, we don't get it very well, but it is the best we can do with the data we have available at the time.
▶ 0:56:56Dr. Makary: So the group -- the international gip group chose to no longer include the influenza b strains a couple of years ago. It sounded like a very reasonable decision. We also went along with that recommendation. But I think we are aligned in that the american public ought to have some confidence that independent scientists are looking at these data.
▶ 0:57:19Chair Cassidy: Going back to the transparency, it seems what is lost with the opening meeting is a transparency. How can you as fda commissioner advocate for that transparency? We want the american people to know. Canceling the meeting will shut that door a little bit.
▶ 0:57:38Dr. Makary: Senator, I was not involved in that decision.
▶ 0:57:42Chair Cassidy: I accept that. But we are voting for you, so how are you going to make it happen is my question.
▶ 0:57:48Dr. Makary: You have my commitment to review with the committees are doing, how they are being used. I was critical when that committee was not convened at all during one of the covid booster guidance decisions by the fda, and the fda career leadership at the time argued that they are advisory and we do not have to convene them. That was repeatedly throughout the biden administration.
▶ 0:58:17Dr. Makary: There may be some value if there is a place where efficiencies can be made. But with something that is important, something where we want expert opinion, not only provides some of that wisdom, but it also increases the perception of competence from the general public.
▶ 0:58:36Sen. Murray: Thank you for being here today. Let me follow up on that. Last week I sent you a letter, along with some of my colleagues, asking you about the fda cancellation of the vaccine advisory committee meeting. For everybody's information, this is a meeting that takes place annually, for at least 30 years, to make recommendations on which influenza strains should be included in flu vaccines for the upcoming flu season.
▶ 0:59:02Sen. Murray: For the first time in decades, fda canceled the meeting with no explanation and no new date. That is unprecedented and dangerous, and you just referred to it. In 2022, you raise concerns when the fda was considering not holding a vaccine committee meeting to authorize covid-19 boosters.
▶ 0:59:26Sen. Murray: At the time, you said it was unconscionable and undermined the integrity of the fda standard process to not hold that committee meeting. So if you are confirmed, will you commit to immediately reschedule that vaccine advisory committee meeting to give the expert views we need to know, so we can have the correct vaccine for the upcoming flu season?
▶ 0:59:52Dr. Makary: Thank you for the question and I appreciated our time together in meeting ahead of this hearing. I was not involved in that decision.
▶ 1:00:03Sen. Murray: Will you immediately reconvene it?
▶ 1:00:07Dr. Makary: I will immediately reevaluate which sessions the leadership -- which decisions, which topics could benefit.
▶ 1:00:18Sen. Murray: We need to know what flu vaccine to have. What are you reevaluating?
▶ 1:00:26Dr. Makary: For the last seven or eight years I have and following it, they simply adopt verbatim the recommendation of the international gip group. What I was not involved in that decision. I will say that in my opinion it was a huge difference between requiring every 12-year-old girl in america to take an eighth covid booster shot versus rubberstamping the recommendation from the international gip group, which has done it seven out of the last seven years.
▶ 1:00:54Dr. Makary: I'm not saying that the decision is something I was aware of or involved in, but it is something I will look at if confirmed.
▶ 1:01:05Sen. Murray: I'm very unclear because the fda is the gold standard for all of us. This committee hearing is what has always been what we look to, the fda look to, the american people look to, to learn what the flu vaccine is. What are you going to look at to make a determination and figure something else out, decades into this? What are you relook at?
▶ 1:01:27Dr. Makary: Senator, I was not involved in that decision, but the committee --
▶ 1:01:33Sen. Murray: I'm looking for you to say we will reconvene immediately so we can let our experts and doctors know what flu vaccine to have next fall.
▶ 1:01:43Dr. Makary: The committee members and the career professional scientists at the fda look at the recommendation of the international gip group, and they say ok.
▶ 1:01:54Sen. Murray: You just told me you were going to reevaluate it, and I want to know what you are reevaluating it on. What are you looking at to make the decision whether to reconvene?
▶ 1:02:02Dr. Makary: In conjunction with the center director of the biologics center, I would reevaluate which topics deserve a convening of the advisory committee members, and which may not require the convening.
▶ 1:02:20Sen. Murray: What would we base the decision on?
▶ 1:02:22Dr. Makary: You can ask the biden administration that chose not to convene the committee meeting for the covid booster.
▶ 1:02:30Sen. Murray: I understand, but I am asking you. How will we know what flu to take next year, vaccine, if this committee does not reconvene and make the recommendation?
▶ 1:02:39Dr. Makary: Senator, I was not involved in that decision not to convene the group.
▶ 1:02:44Sen. Murray: Let me ask you really quickly -- also following up on a question on mifepristone , because fda does play a really critical role in making sure we have safe and effective medications -- contraception and medication abortion have been approved by the fda for many decades, based on mountains of high-quality evidence and expert scientific judgment.
▶ 1:03:12Sen. Murray: If you are confirmed, will you commit to upholding the science and evidence-based drug approvals for all fda approved products, including contraception and medication abortion?
▶ 1:03:22Dr. Makary: Thank you for the question, senator murray you have my commitment to follow the independent scientific review process at the fda, which is a tried and true process that has been around. That is my commitment to you.
▶ 1:03:41Sen. Murray: There have been over 100 high-quality studies over more than two decades backing up the science and safety of mifepristone.
▶ 1:03:47Chair Cassidy: Senator paul?
▶ 1:03:52Sen. Paul: Congratulations on your nomination. I think one of the most important things we need in government are people who are open-minded. I think closemindedness, the idea that this is settled and no one will ever -- if you see data and you have to make a decision, are you willing to lead where the data and the facts take you, as opposed to preconceptions?
▶ 1:04:14Dr. Makary: Absolutely, senator paul. I think it is part of being a scientist. We need more humility in the medical establishment. You have to be willing to evolve your position as new data comes in. The people who are not involved
▶ 1:04:31In Science -- Sen. Paul: The people who are not involved in science think we should submit to whatever science is, but you mentioned to me that yesterday you removed a gallbladder through a leprous go. I was in medical school in surgical training about the time where everybody made a four or five inch the incision -- v incision to take the gallbladder out.
▶ 1:04:59In Science -- Sen. Paul: The older surgeons who ran the surgery departments were like it is malpractice to use these tiny incisions and blow the air into the abdomen, and all of this. But the overcoming of the consensus -- do you remember that? Do you remember trends from the larger incision to the smaller incision, the resistance to the consensus?
▶ 1:05:19Dr. Makary: Yes, senator. I can tell you some of the surgeons who trained me said things like big surgeons use big incisions, and the bigger the incision, the better. Without a big, open incision, you cannot really see what you were doing. And a leprous scope gives you 10 times the magnification, but there is a lot of medical dogma that has contaminated our feel. I think it has tended to a lack of humility. As I teach my residence, it's not how much you know.
▶ 1:05:50Dr. Makary: It is your humility and your willingness to learn as you go, from patients.
▶ 1:05:54Sen. Paul: I think some people here are not impressed enough by what it takes to do the kind of surgery that you do. I'm an ophthalmologist and I do I surgery, and we do really tiny incisions. But our surgery last between five and 20 minutes to take out a cataract. You have done a surgery on the liver. How long does that take? I thought you did those.
▶ 1:06:19Dr. Makary: I have done a lot of those operations and transplant procedures, and pioneered a new type of procedure which is a laparoscopic pancreas transplantation, with hopes it could be used to cure diabetes. It was about eight hours for that operation when we started. We had gotten it down to about four or five hours. We did some leprous capital he in three hours.
▶ 1:06:47Dr. Makary: -- leprous cop -- lapro scopically than three hours.
▶ 1:06:55Sen. Paul: One of the questions I have been bringing forward is whether there could be a conflict of interest. One of the things I have asked that you think would be universally accepted by everyone is you should have to reveal if you get royalties from drug companies. If you are making a decision on a pfizer or a moderna vaccine, I would think the least of the transparency should be to reveal if you get royalties from those companies.
▶ 1:07:22Sen. Paul: Do you think we need to evaluate the people on the committees or see whether they get royalties, or see whether there are a conflict of interest with people making these decisions?
▶ 1:07:30Dr. Makary: Yes, I do. We need to review the ethics policy because people see things that appear to be a cozy relationship between industry and the regulators that are supposed to be regulating the products. I want american companies to thrive. But we need to call balls and strikes to keep that independent scientific review process free of any conflicts. I think it deserves a look.
▶ 1:07:59Sen. Paul: A lot of people would think there is a consensus on whether to take all the vaccines are not. Most of europe does not recommend a covered vaccine for under age 12. Some, under 18. And it is because if you look at the risk and benefit and some of the possible comp locations of it -- it is different for older people. These are things we should at least discuss and evaluate.
▶ 1:08:26Sen. Paul: Some of the most pro-vaccine people, when the policy came out to give boosters to your six month old, said they would not even give it to their 24-year-old, the booster. Remember one of the famous committee members -- to committee members left the vaccine committee because the cdc under biden political -- politicized the process and overrode the vaccine committee. To insinuate there is some brand-new thing going on -- these are long-standing controversies.
▶ 1:08:55Sen. Paul: I think the main thing I will go back to is we need open mindedness, and I appreciate your willingness to look at the data and not be overwhelmed by preconceptions.
▶ 1:09:08Sen. Baldwin: Thank you, Mr. chairman. I want to go over a couple of topics that have already been raised, and if we have time, explore one that has not yet. But I want to -- I want to understand your position on mifepristone, because we had an opportunity to speak in my office, and I thought that you were pretty clear with me during that meeting that you were aware
▶ 1:09:41Sen. Baldwin: Of the overwhelming scientific conclusion about the safety of this medication, and you did not think politics should be involved in decisions, moving forward. I understood from our conversation that you intended to stand behind the fda's long-standing determination.
▶ 1:10:01Sen. Baldwin: But after our meeting, I don't know if it was you or your minders, but they followed up with my staff and said they felt that you misunderstood my question, and wanted to clarify your answer. Which, by my read, implied that you are open to totally re-examining the scientific determination, even with decades of evidence.
▶ 1:10:29Sen. Baldwin: So I want to clearly understand your position. As fda commissioner, will you maintain current access to mifepristone?
▶ 1:10:38Dr. Makary: I will be very clear about my position. My position is that of a scientist. As you know, part of the risk evaluation mitigation strategy was put on -- was put in initially by president clinton and that administration, and then modified under obama and again under president biden. It requires ongoing data collection. I cannot prejudge that data without looking at it.
▶ 1:11:09Sen. Baldwin: You said something about convening an ongoing panel. A previous question.
▶ 1:11:15Dr. Makary: I did not mention a panel. I said I would convene the scientists, professional career scientists, who have reviewed the totality of data on this and are also looking at ongoing data that is being collected. There could be a drug-drug interaction that may show up in the data.
▶ 1:11:37Sen. Baldwin: I want to ask, if that is your approach to something that has been approved for decades -- are you going to do the same with tylenol? There are a lot of side effects for daily use, including liver damage. Will you be doing that for tylenol?
▶ 1:11:54Dr. Makary: As you may know, senator, tylenol does not have a regulation requiring a risk evaluation.
▶ 1:12:03Sen. Baldwin: I'm not asking whether it does or not. I'm asking, are you going to do ongoing surveillance of the possible side effects for that drug that was approved many years ago? How about asthma inhalers? They have been associated with osteoporosis, opportunistic lung infections. Are you going to be doing that for those medications?
▶ 1:12:26Dr. Makary: Senator, I will be following the law, and the regulation requires --
▶ 1:12:32Sen. Baldwin: You are going to have a totally different approach to this. Want to get to a little bit more about what we are talking about with the influence of vaccines in general. As has been said, in this hearing, the advisory committee annual meeting was canceled, for selection of what strain of influenza our vaccines for this next season would confront.
▶ 1:13:01Sen. Baldwin: There have been additional reports that secretary kennedy will make -- wants to make significant changes to another advisory committee that makes recommendation and provides advice to that for vaccines. I worry that this is a ploy to install vaccine skeptics on these critical panels. Our advisory committees must maintain scientific integrity.
▶ 1:13:32Sen. Baldwin: And should not be changed for political purposes, or to further an agenda. Dr. makary, do you intend to remove experts from the vaccine and biologics advisory committee?
▶ 1:13:47Dr. Makary: Senator, I'm not familiar with what you are referring to regarding secretary kennedy. Secretary kennedy wants to make america healthy again. With regard to the vaccine committee deciding which flu strain to identify, I was not involved in that decision. Again, just as a reminder --
▶ 1:14:09Sen. Baldwin: Are you planning to remove any experts from the vaccine and related biological advisory committee?
▶ 1:14:16Dr. Makary: I have no conceived plans to rearrange that committee or any committee. I will say on influenza --
▶ 1:14:23Sen. Baldwin: Do you commit to maintaining scientific integrity on advisory committees and receiving regular outside expertise?
▶ 1:14:30Dr. Makary: Of course.
▶ 1:14:32Sen. Baldwin: Ok.
▶ 1:14:35Chair Cassidy: Senator collins?
▶ 1:14:39Sen. Collins: Thank, Mr. chairman. First of all, Dr., I appreciate your willingness to serve. I was impressed as a result of our c1 conversation in my office. Let me ask you a question.
▶ 1:15:05Sen. Collins: If confirmed will you reinstate meetings of the committee?
▶ 1:15:13Mr. Makary: Yes.
▶ 1:15:18Sen. Collins: February, we learned hundreds of probationary employees at fda were dismissed. This concerns me. We need young scientists/researchers since we are seeing retirements/resignations.
▶ 1:15:48Sen. Collins: More than half of fda employees are funded under various user agreements so there is revenue coming into fda to pay for these employees. If confirmed, will you, not an outside force, have full authority over fda staffing decisions?
▶ 1:16:16Mr. Makary: If confirmed, I will assess staffing/personnel at the agency. I have not been involved in any decisions regarding personnel changes recently.
▶ 1:16:35Sen. Collins: I want to make sure you are the one doing that assessment. I'm not saying the staffing level is perfect. It is helpful for a new commissioner to assess but I want that person to do it. It sounds like you are committing?
▶ 1:16:57Mr. Makary: Yes.
▶ 1:17:00Sen. Collins: One of the best ways to lower the cost of prescriptions is by promoting more market competition and one way to do this is making it easier for generic and bio similar drugs to come to market.
▶ 1:17:23Sen. Collins: As part of a broader bill senator shaheen and I have introduced to help lower the cost of insulin, we have included provision to create a new competitive bio similar pathway, therapy designation at fda under which eligible products for which there is inadequate bio similar competition now could achieve
▶ 1:17:54Sen. Collins: Expedited review. I worked with fda in last congress to develop this. I look forward to continuing to push this concept so it becomes law. Do you support concept of a new expedited pathway for bio similars to compete for example with branded insulin?
▶ 1:18:23Mr. Makary: You have taken a strong interest in fda and I appreciate it. I enjoyed our time together. Thank you for your leadership on the diabetes caucus. It is close to my area of medicine. I believe we need to figure out a way to get bio similars approved quicker without cutting corners on scientific review.
▶ 1:18:53Mr. Makary: It is one of several strategies fda can do to try and alleviate problems of high prices, inadequate competition or underperformance of competition and drug shortage in the U.S. other strategies could include the way we look at generics, moving medications to over-the-counter. Does naloxone need to be prescription only?
▶ 1:19:23Mr. Makary: Does epipen need to be prescription only? Over-the-counter, we can feel confident about public safety with those products on the shelf of a pharmacy, it would force the companies to put a price on the shelf and I believe transparency would have an effect on the entire market.
▶ 1:19:45Sen. Collins: Delighted with your interest in type I. There are clinical trials underway. Exciting development.
▶ 1:20:04Chair Cassidy: Senator hassan.
▶ 1:20:08Sen. Hassan: Good morning and congratulations. President trump has helped to promise -- has promised to help lower drug prices.
▶ 1:20:30Sen. Hassan: In 2025, manufacturers have raised the price on over 500 medications. If confirmed will you work with me to speed the approval of generics at fda to lower the cost for americans?
▶ 1:20:48Mr. Makary: I enjoyed our meeting. Emphatic yes. I would love to work with congress to address the way patent law has enabled patent thickening which makes it more difficult for bio similars and generics to come to market because they have to navigate so many suits.
▶ 1:21:10Sen. Hassan: This is something senator paul and I have been working on. It would allow fda to communicate transparently with manufacturers to make more low-cost prescriptions available to patients. The bill would save taxpayers $1 billion and has bipartisan, bicameral agreement. Encourage my colleagues to look.
▶ 1:21:42Sen. Hassan: We discussed mifepristone, which has been used for decades in abortion and miscarriage care. You mentioned you were not familiar during our meeting and I followed up with decades of safety data. Have you reviewed it?
▶ 1:22:04Mr. Makary: Thank you for sending me homework. I read those articles. What I was referring to when I said I wasn't familiar with it, I don't believe I said I wasn't familiar, I set I have not reviewed the totality of the data.
▶ 1:22:25Mr. Makary: I am familiar with mifepristone and I reviewed those studies including surveys of patients inquiring about telemedicine, a 2018 national academy of medicine review, I am a member of the national academy of medicine and was not involved in that particular review.
▶ 1:22:43Sen. Hassan: I shared that study were scientists looked at over 100 studies of medication and found the literature has proven mifepristone safe and effective. The r.e.m.s. Process, 2021, fda looked again based on a citizens petition.
▶ 1:23:12Sen. Hassan: This is the report back from fda about review and modification of language in the r.e.m.s. Process and their review was it was safe/effective. So the public can understand, there is lots of data here. That supports the safety and efficacy of mifepristone.
▶ 1:23:43Sen. Hassan: The concern your hearing is not about whether you will follow ongoing r.e.m.s. With any medication and look at most current data -- that's what the scientific process is about -- the concern is whether you will unilaterally overrule data that currently exists for political reasons. That is what we were looking for reassurance on. I believe you are an independent scientist. You have a distinguished career as a physician.
▶ 1:24:12Sen. Hassan: We need to know that is really what you mean and that when politics get heated around abortion, you won't abandon that independence?
▶ 1:24:21Mr. Makary: You have my commitment in office I will do review of data. No preconceived plans to make changes to mifepristone policy and I plan to follow the law and regulation of r.e.m.s. To look at ongoing data. There could be a drug interaction --
▶ 1:24:48Sen. Hassan: I understand. What I am looking for is an understanding that the current state of science, the process of which you have participated in your entire career and that others here have also participated in, that you will follow the science has currently developed and not unilaterally overrule scientists because you are under political pressure to do so.
▶ 1:25:12Mr. Makary: If you look at my record, I have never been afraid to speak my honest opinion. I have no preconceived plans to make changes on that medication.
▶ 1:25:27Chair Cassidy: Sen. murkowski: I understand. The senator from alabama as an engagement. Florida, go gators. Katie britt would want me to say roll tide. >> you would lose your votes in florida.
▶ 1:25:56Chair Cassidy: >> I am grateful as a rookie to question before these senior senators. I am honored. I'm excited to see you. I was incredibly happy with this nomination. I know you will do a great job. Two issues are relevant to the two main roles in my life over the last six years, one as mother and one as ag of florida.
▶ 1:26:30Chair Cassidy: Fda, burying its head in the sand about illegal chemically written extraordinarily high amounts of nicotine chinese vapes flooding the U.S. market. Two thirds of the export market from china, these vapes, two thirds of the market here are chinese vapes. It is unbelievable. Strawberry blow pop, watermelon, sour barry.
▶ 1:27:02Chair Cassidy: Attracting and addicting children. We have so many thousands of pending applications. Most of these are illegal in the U.S. now yet somehow china decided to flutter market with illegal vapes, with U.S. market of illegal vapes and they are benefiting. In china, they banned flavored vapes.
▶ 1:27:30Chair Cassidy: All the manufacturers there of these chemical vapes have flooded our market and are addicting our children. Much like we are seeing this, fentanyl, etc. Whoever comes in as head of fda, this is a problem you have to address immediately. These are all over the U.S.. Convenience stores, readily available to children.
▶ 1:28:02Chair Cassidy: If you walked in anyone right now you would find them. Not only are the amounts of nicotine going up and up, we don't know what is in these things. There has been little to nothing done about pending applications at fda or to enforce those we know our legal right now. How would you address those?
▶ 1:28:26Mr. Makary: I appreciate your passion on this important issue, and your work as ag in florida. Maybe it is because you both believe in doing the right thing and you are a baseball mom.
▶ 1:28:42Sen. Moody: I heard about this on the bleachers at a game.
▶ 1:28:46Mr. Makary: Four new vaping stores have popped up in my neighborhood in the last few years. I have not walked in one of them but perhaps I should. You're right. We are being flooded with chinese products. We have no idea what is in them. Public health will not even be able to study them because it takes so long for public health research to catch up.
▶ 1:29:18Mr. Makary: It is not right that they are banned in china yet they are sending them to the U.S. there are a few things fda can do. Office of inspections/investigations has people with guns, they do enforcement and rates, in collaboration with doj and other enforcement to try and address this problem of illegal products on the market.
▶ 1:29:47Sen. Moody: Once people finally convinced the administration people were getting addicted, there was a big announcement. That is great. Florida had to step up and do it ourselves because federal would do nothing. How do you clean up fda first? You need to know the law before you can enforce.
▶ 1:30:15Sen. Moody: Let's focus on that and then we will work with the enforcement measure. Commitment from you, citrus growers, the state of florida, that is a big deal. There is arbitrary regulation about sugar content. It needs to be examined with seeds and greening and the citrus industry.
▶ 1:30:39Sen. Moody: Arbitrary regulation, oranges aren't producing as much sugar -- your commitment to look at that regulation, things that are set sometimes we need to revisit on how it is affecting industries across the U.S.
▶ 1:30:54Mr. Makary: I have my coldpressefd freshly squeezed orange juice this morning.
▶ 1:31:03Sen. Moody: Thank you so much.
▶ 1:31:07Chair Cassidy: That was a great murder board that told you to drink the orange juice.
▶ 1:31:14Sen. Kim: Your opening statement, you said fda was the gold standard of transparency. I was glad. Is it important we insure there is public comments on actions of agencies/departments overseeing important aspects of our lives?
▶ 1:31:41Mr. Makary: It was good to meet you, I enjoyed our conversation. I believe in civil discourse and have been an advocate coming out of an era of medical establishment censorship. I believe in the principle. There are laws/regulations around public comment periods. In some situations, it is required by regulation.
▶ 1:32:10Sen. Kim: The public is concerned about restoring trust. A big part of that is involving the public market. Questions around verpac/ recently there was an effort addressing the waiver. I asked you to look into this.
▶ 1:32:36Sen. Kim: I think it's important we maintain public comment comment something so far hhs has not abided by that has been long-standing practice. A lot of this has been transparency and accountability. Do you support the roles of inspector general's?
▶ 1:33:02Mr. Makary: Senator I believe in the law and the process of having inspector general's.
▶ 1:33:12Sen. Kim: If confirmed I urge you to do everything you can to ensure hhs has an inspector general, ability to oversee the accountability. I hope both of us agree. Your commitment on that front, you would push to try to have an inspector general at hhs.
▶ 1:33:34Mr. Makary: Thank you senator.
▶ 1:33:36Sen. Kim: You want to have ethics review, positions people might be having involving approval of drugs. I came across something that said you were willing to divest from your investments perceived potentially as conflict of interest if you are confirmed?
▶ 1:34:02Mr. Makary: The office of government ethics does comprehensive review of everything I own, stock, equity, share. I would describe it as a colonoscopy with a small bowel follow-through. They gave me the option of resigning from some things or maintaining a role. I chose voluntarily to divest and resign from everything.
▶ 1:34:32Sen. Kim: Applaud that. That should be the standard for such an important job. Further here, would you agree to recuse yourself from matters involving your former clients and employers if that comes before you at fda?
▶ 1:34:49Mr. Makary: What I can promise is to abide by the guidance of the office of government ethics.
▶ 1:34:58Sen. Kim: I understand. You voluntarily took steps to divest. You were not required to, though I think you have been, but again, would you consider recusing yourself? Again, if you are making decisions about previa clients, you would see how the general public would react to that, concerns about whether or not you are doing this for the best interest of people or people you know?
▶ 1:35:28Mr. Makary: I have signed to agree to refusals as defined by the office of government ethics in areas they perceived conflict could occur. I agreed to refusals required by the office of government ethics.
▶ 1:35:45Sen. Kim: What is you feeling about potential medicaid cuts being reviewed in congress?
▶ 1:35:56Mr. Makary: Fda is not involved in medicaid or coverage decisions.
▶ 1:36:03Sen. Kim: In your opening remarks, I thought it was powerful, you said your motto in life has been about treating everyone in the community equally especially the most honorable. -- vulnerable. You will have a seat at the table. Medicaid is essential for the most vulnerable amongst us, treating everyone equally. It's not just about approval.
▶ 1:36:35Sen. Kim: You want to see them in the hands of americans, so I do think you have an interest in preserving medicaid.
▶ 1:36:42Chair Cassidy: Sen. murkowski:. Welcome, it was a good conversation, thank you for the encouragement to read that provision in your book. Thank you for the assurance you gave to senator collins regarding the vaccine advisory committee.
▶ 1:37:09Chair Cassidy: For several of us who had substantive conversations with secretary kennedy, we received assurances about things like the committee. Making sure that important input goes forward is important to many of us. An issue we discussed in my office with regards to als.
▶ 1:37:39Chair Cassidy: Fda accelerated approval pathway has been important, promising treatments for als and other diseases. You advocated for using common sense alongside science and regulatory decisions. Briefly, how do we define common sense here as it applies to regulatory decisions at fda?
▶ 1:38:08Chair Cassidy: How's we make sure als patients, who are looking at a limited timeframe, they cannot wait for the traditional approval process. There are emerging measures using digital technologies. Is this in your realm of common sense? Give me a little of your view here on how you would like to proceed on these accelerated approval pathways?
▶ 1:38:35Mr. Makary: I enjoyed our time together. Talking through these issues. We have to customize regulatory process to condition we are trying to offer help for. A condition affects 19 people in the world, as a partial trip location chromosome 15 disorder, a disease that affects 52 kids in the world.
▶ 1:39:07Mr. Makary: We cannot require two randomized controlled trials. We have to customize the regulatory process if our goal is to provide safe and effective therapies. I believe firmly in that approach. I think we can use common sense to ask big questions we have never asked before. Why does it take 10 years for a drug to get approved?
▶ 1:39:34Mr. Makary: Why does a college student suffering from chronic abdominal pain for years, have no idea what's going on, they go to italy for a summer and they are suddenly cured of abdominal pain? Why does a peanut allergy medication that has been safe in data for decades get approved in europe before the U.S. when nearly 10% of our population has a food allergy? There are a lot of areas where we can ask, does a drug need to be prescription? Can it be over-the-counter?
▶ 1:40:07Mr. Makary: Why do we require glucose monitors to have a prescription when it is good for people to use these monitors and learn about what they are eating. We don't want to monitor, we want to prevent diabetes when 30% of our nation's children have some form of diabetes, why are we withholding these tools until after they are sick? The same with continuous blood pressure monitoring.
▶ 1:40:38Sen. Murkowski: We want to make sure there is a level of safety at fda but being able to accelerate these in ways meaningful and to your point that fit with the population you are speaking to. I will be pushing you on this as well as many other advocates.
▶ 1:40:59Mr. Makary: Thank you.
▶ 1:41:01Sen. Murkowski: Food safety inspections. State, local governments conduct 60% of food processing facility inspections, 90% of produce safety inspections, 100% of retail. In the biden administration we saw fda planning to cut funding for state and local food safety programs which impacts alaska when it comes to seafood and other areas.
▶ 1:41:33Sen. Murkowski: I am looking for commitment from you under the trump administration fda will maintain funding for contracts with state and local governments. They have proven it is more cost-effective, efficient. It is what congress has asked for. I would like to know you will be supported in that regard?
▶ 1:41:54Mr. Makary: I am happy to look at that with you.
▶ 1:41:58Chair Cassidy: Senator blunt rochester.
▶ 1:42:05Sen. Braun: Rochester: thank you for taking time to meet with me. I found most parents would do anything to keep their children safe and healthy which is why we probably see intense debate on the best ways to protect our children and the fda historically has been the root of authority about reliable
▶ 1:42:36Sen. Braun: Information about public health issues relating to food, tobacco , cosmetics, dietary supplements . People are getting their information in many places now. We are faced with a growing challenge of opinions replacing scientific consensus and the proliferation of misinformation and disinformation. Parents need accurate science-based information to help make informed decisions about their children.
▶ 1:43:02Sen. Braun: How would you use your position to compete with uninformed voices and share evidence-based information free from political influence?
▶ 1:43:14Mr. Makary: I enjoyed our meeting together. I believe in empowering people with good info. I have written three best-selling books to try and educate people about health. You can explain to people with humility what we know and what we don't and then they are going to trust us more. Trust in doctors and hospitals is at a crisis now. It was 71% in 2019.
▶ 1:43:46Mr. Makary: It is down to 40%. That is a 39 point drop in my profession. Major problem. If we have the cure for pancreatic cancer but only 40% will take it because the rest does not trust us, that medication is only 40% effective. I think we fight bad ideas with more ideas. I don't believe in censorship. Scientific opinions. We need civil discourse.
▶ 1:44:15Mr. Makary: Unfortunately we have a toxic discourse now in the U.S., the politicization of immune cells in some cases.
▶ 1:44:23Sen. Blunt Rochester: One of my concerns is who those voices are and that they be robust scientific messengers as well. Drug shortages have reached an all-time high threatening access to products we use every day from iv bags and drugs for cancer.
▶ 1:44:48Sen. Blunt Rochester: It is concerning for children's hospitals because pediatric drugs and supplies that must be formulated to accommodate children's unique needs. Yes or no, do you agree fda should play a leading role in mitigating shortages?
▶ 1:45:03Mr. Makary: I love yes and no questions.
▶ 1:45:06Sen. Blunt Rochester: Can you do it?
▶ 1:45:10Mr. Makary: They should take a role. The problem is bigger than fda.
▶ 1:45:16Sen. Blunt Rochester: You are not sure.
▶ 1:45:18Mr. Makary: I would refer you to my article in jama on this topic.
▶ 1:45:25Sen. Blunt Rochester: Clinical trials. We talked about the importance of clinical trial diversity. I want assurance you would stand up to any trump administration actions that conflict with this. Do you believe clinical trial diversity is clinically important? Easy one.
▶ 1:45:45Mr. Makary: If you are talking sickle cell disease, do we need white people in a sickle cell disease -- I believe in common sense and clinical trial diversity. If you are going to make results extrapolated to general population, you should have results in those populations you are making recommendations for.
▶ 1:46:08Sen. Blunt Rochester: Is it acceptable for the administration to remove congressionally mandated guidance documents on clinical trial diversity?
▶ 1:46:17Mr. Makary: I'm not familiar with that.
▶ 1:46:19Sen. Blunt Rochester: Should you be confirmed, will you reinstate and finalize this document after you look at it as one of your first actions? Could you commit to looking at that?
▶ 1:46:32Mr. Makary: Yes.
▶ 1:46:33Sen. Blunt Rochester: Good answer. [laughter] will you restore the website for the office of minority health and health equity?
▶ 1:46:41Mr. Makary: I'm not familiar with that.
▶ 1:46:43Sen. Blunt Rochester: If there was one and you knew there was one, would you restore the website that would provide information to the american people?
▶ 1:46:52Mr. Makary: I think you're asking me to make a decision on information I don't have. You have my commitment to look.
▶ 1:47:00Sen. Blunt Rochester: If you got the opportunity to review the website and know that it would help to spread real information, science-based information, would you reinstate that website?
▶ 1:47:14Mr. Makary: I would be happy to review that.
▶ 1:47:17Sen. Blunt Rochester: I have more questions I will send for the record. I'm concerned about the vaccines for children program. You have heard the cancellation of the meeting. This is not just about cost for families, which is huge right now but it is also coverage. Yield back time. Thank you.
▶ 1:47:45Sen. Hawley: Great to see you. Congratulations. Thank you for your willingness. 2000, president clinton's fda approved chemical abortion regimen with mifepristone and miss oppressed all.
▶ 1:48:10Sen. Hawley: Fda concluded mifepristone could not be safely used, I am quoting, "without special measures." in particular fda mandated prescribers needed to be licensed physicians able to diagnose and treat ectopic pregnancies to determine gestational age of the baby and the fda further required drugs be administered in person, a day one administration of the
▶ 1:48:41Sen. Hawley: Drug, day three, second wave of the drug, day 14 check in for complications and the fda emphasized given the potential risks of these drugs, physicians needed to provide ongoing care. Fda also said "percentage of women who considered any adverse event severe." they also included a black box warning.
▶ 1:49:12Sen. Hawley: Those restrictions were largely in place until a couple years ago when the biden administration after the U.S. supreme court took up the dobbs decision, at that point, they decided to eliminate 20 years of in person dispensing requirements for this drug. They didn't cite studies they said were adequate, that the fda acknowledged the studies did not take into account new protocols they were assuring.
▶ 1:49:44Sen. Hawley: They just eliminated two decades of in person dispensing requirements. Given fda's findings on this drug over two decades, doesn't it make sense fda return to the pre-political, before political intervention of the biden administration, protocol that requires in person dispensing for chemical abortion drugs?
▶ 1:50:08Mr. Makary: I appreciated our conversation prior. It makes sense to review the totality of data. I know personally of ob doctors who preferred to insist even though they have the option to prescribe otherwise, they choose to insist mifepristone be taken when necessary in their office as they observe the person taking it.
▶ 1:50:35Mr. Makary: The concern here is the drug in the wrong hands could be used for coercion.
▶ 1:50:43Sen. Hawley: It is not merely that there is no requirement it be ingested, there is no in person dispensing requirement whatsoever. Two decades of in person dispensing requirements the biden administration eliminated. You are aware in 2016, the obama fda eliminated the requirement physicians record adverse events with regard to mifepristone?
▶ 1:51:12Mr. Makary: They limited the data required to fatalities but not adverse events.
▶ 1:51:18Sen. Hawley: Will you put back in place the full reporting requirements?
▶ 1:51:22Mr. Makary: I am happy to look at it. I believe in data. I don't believe in prejudging data before someone has taken a look, including future data.
▶ 1:51:33Sen. Hawley: Fda rules were consistent and stable for 20+ years until the dobbs decision appeared. All of a sudden we got massive changes in dispensing requirements of this drug. Over 60% of abortions in the U.S. are now carried out with chemical drugs. They're not done in clinics/hospitals.
▶ 1:52:01Sen. Hawley: They are done with these drugs without physician supervision, without any physicians there if there is a serious adverse event. If the biden rules are allowed to stand, it doesn't matter what voters in the states, this is a serious difficult and moral issue, the case of life and abortion, it won't matter what the voters say because the biden rules say, it doesn't matter
▶ 1:52:32Sen. Hawley: What voters in the state have decided, they can mail in -- if that is allowed to stand, we may as well go back to the supreme court because now washington bureaucrats are making decisions. Doctors are not involved. State voters are not involved. This is extremely concerning to me.
▶ 1:52:52Sen. Hawley: It ought to be concerning to everyone who is concerned about women's safety, also the position which I thought of this administration, it ought to be voters in the state, delegated to these localities. I know you are familiar with this. I appreciate your commitment to data. I hope you will look at the full range of data and I hope we can count on you to protect women's health and the health of the unborn.
▶ 1:53:19Sen. Hawley: Let the record reflect, even though I have a gavel, I will stop now.
▶ 1:53:24Sen. Kaine: Senator hawley and I share a unique perspective here, two sets of senators who went to the same high school. Chuck schumer and bernie sanders went to james madison. We went to rock hurst in kansas city. Put that on the record. I loved the opportunity to visit you.
▶ 1:53:50Sen. Kaine: You didn't have anything to do with the layoff of the 1000 fda employees?
▶ 1:53:55Mr. Makary: Correct.
▶ 1:53:58Sen. Kaine: Do you know anything about the layoffs?
▶ 1:54:05Mr. Makary: I do not.
▶ 1:54:07Sen. Kaine: When you come into the office, you will do assessment. I suppose if you look at this going forward, you think personnel policy including layoffs should be done strategically rather than willy-nilly across the board?
▶ 1:54:24Mr. Makary: I am open to ideas on making government more efficient.
▶ 1:54:30Sen. Kaine: Do you think willy-nilly is a good idea?
▶ 1:54:34Mr. Makary: I am a surgeon. Surgical answer.
▶ 1:54:40Sen. Kaine: That's good. It is puzzling. The administration has confidence in you. They expect you to be confirmed. Probably will be. The notion they would lay off 1000 before you got there is unusual. We are seeing that it is willy-nilly random. Probationers are disproportionately veterans. They cannot fight back.
▶ 1:55:12Sen. Kaine: I'm glad you will be a surgeon and act like a surgeon should you be confirmed. User fees. We chatted about this in office. Despite the need for reforms that fda, the fda is the gold standard. I asked you if there was another nation that does this better than us and you said no. Here is an issue that is technical.
▶ 1:55:42Sen. Kaine: Tracking adverse events after a drug or medical device is approved. You indicated fda can do a better job of identifying issues or problems already on the markets. Approval and postapproval tracking. There are many user fee programs that outline relationship between fda and industry.
▶ 1:56:06Sen. Kaine: For most programs except medical device user fee, fda can use collective user fee dollars to conduct postmarketing surveillance but the medical device program does not allow that use of user fee dollars. Should the fda be able to use user fees collected on medical devices to do postapproval surveillance?
▶ 1:56:30Mr. Makary: User fees are established by congress. I am happy to be part of the conversation about the best use of those dollars within agencies. I enjoyed our conversation, committing to an fda that delivers cures for americans and meaningful treatments.
▶ 1:56:50Sen. Kaine: Do you think postapproval surveillance is important?
▶ 1:56:56Mr. Makary: I am a big believer in the idea we should not turn a blind eye after the fda approves. If we do that, we get burned with a million lives lost from oxycodone and oxycontin.
▶ 1:57:11Sen. Kaine: Making that change would be on congress. I think it is odd we don't allow user fees to be used for postapproval surveillance on medical devices, when we do in other areas. I would love to work with you on that. On oxycontin, we are seeing improvements.
▶ 1:57:32Sen. Kaine: 24% decline in overdose for the 12 months ending in september '24 compared to the previous year and yesterday nih released findings of a study researching a new pathway to address pain issues. 87,000 americans died in those 12 months of overdose. We have much farther to go. 1-4 virginians.
▶ 1:57:58Sen. Kaine: Can the fda not just be in receive mode to get the applications for approvals -- can fda be proactive and say how come we don't have more non-opioid based pain management strategies? The fda shouldn't pick a winner among competitors but look at gaps and try to encourage filling those gaps smartly.
▶ 1:58:26Sen. Kaine: Some of your ideas how we should encourage innovative strategies to address chronic pain without opioids?
▶ 1:58:34Mr. Makary: I believe fda should not be in just receive mode but partner with industry and facilitate process and ensure scientific review is independent at the same time without cutting corners on the independence of that review. The opioid pain problem can also be addressed by innovation, more localized treatments. Looking at postapproval monitoring of devices.
▶ 1:59:01Sen. Kaine: Thank you.
▶ 1:59:03Mr. Makary: Thank you.
▶ 1:59:09Senator: Thank you for being here and your willingness. World war ii, we had to feed our troops. We knew nothing about preservatives, canning foods. Ever since, our food has gone downhill. We put everything in the world and our food. Kids are addicted to it. We have lost a couple generations because of obesity and diabetes. I have faith in this generation. I have two kids in this generation coming up.
▶ 1:59:39Senator: They are looking at their health as the future. They are fired up about nutrition being a good part of it. You familiar with generally recognized safe foods, chemicals -- what are your thoughts as fda director having the ability to look into this?
▶ 2:00:10Mr. Makary: I think you have had perspective on this and been an advocate for healthy foods perhaps because of your unique position where you have worked with young people for so long.
▶ 2:00:28Mr. Makary: Half of our nations children are sick and no one has been doing anything meaningful on this front until we have gotten new momentum and enthusiasm from secretary kennedy and president trump to address the root causes of these diseases. General body inflammation and generalized insulin resistance. Food has a big part of it.
▶ 2:00:50Mr. Makary: When we eat foods with a lot of molecules that do not appear in nature, these are chemicals that the industry insists are safe, a subset of which are concerning. There is a body of research that suggests concern with some ingredients. We have to look at those. You have my commitment to do so if confirmed.
▶ 2:01:13Mr. Makary: These chemicals are creating an inflammatory response in the gastrointestinal tract and with the biome lining that track, kids feel sick. It is not acute. It is a chronic low-grade reaction and they don't feel well. We are drugging our nations children at scale. We have to reassess what we are doing. We are not on a good path now. >> I grew up in the south. I love fried foods.
▶ 2:01:45Mr. Makary: We fry everything including twinkies and snickers. You hear about seed oils. The good and the bad. Your thoughts?
▶ 2:01:55Mr. Makary: A good example of where we could benefit from a consolidation of scientific research and I don't think it is any one ingredient in the food supply that is making our kids sick. 30% rate of insulin resistance and diabetes in american teenagers today. That is a massive signal in data.
▶ 2:02:20Mr. Makary: We have to look at totality of every single thing in the school lunch programs, in the diet of our children. We are using tax dollars to make purchases of foods we know make our kids sick, we have to re-examine how we are spending. One thing I would like to work on is a school lunch program for some districts on a pilot basis to transition to healthier foods.
▶ 2:02:48Mr. Makary: A lot of districts want to but they don't know how and they may not have funds. I have been discussing this with the administration and I hope that is something we can do.
▶ 2:02:58Sen. Tuberville: A few months ago, the former fda director, I asked about red dye 3. It was interesting. Red dye 3, we have done studies on it. We won't allow it in cosmetics. It causes cancer. We are allowed to put it in food. I'm confused. I am a football coach but I am not that stupid. Put it on your face and your stomach, there is no difference.
▶ 2:03:30Sen. Tuberville: He made an interesting statement. We are 20 years behind europe. Europe doesn't allow anything. Looking into red dye 3, all the others. What are your thoughts?
▶ 2:03:42Mr. Makary: I agree it did not make sense red dye 3 was banned in cosmetics but allowed in the food supply. With two business days left in the biden administration there was an annouement to ban it in '27 four '28.
▶ 2:04:04Sen. Tuberville: We want to kill people for two more years? I hope you will look at it quickly and say why do we want to put our people in harm's way?
▶ 2:04:16Chair Cassidy: Senator hickenlooper.
▶ 2:04:20Sen. Hickenlooper: Thank you for your service. I got a chance to look over your books, the three I was able to chase. Each one seemed provocative. I am a slow reader, dyslexic. I wish you had cliff notes, 10 or 15 pages concise and get the essence.
▶ 2:04:46Mr. Makary: I can personally summarize them for you. [laughter]
▶ 2:04:50Sen. Hickenlooper: We have witnesses that just heard that. I'm excited. I appreciate your courage in taking on a lot of traditional approaches and being so candid. In weeks, 10% of fda staff has been laid off and most were inspectors who looked at food supply, whether it was safe, safety of medical devices.
▶ 2:05:16Sen. Hickenlooper: For the past several years, job vacancies, fda inspectors, have been going up, not down. That chaos and understaffing will be a serious morale issue. I don't know if you have plans for that.
▶ 2:05:42Sen. Hickenlooper: How will you try and do the best you can to ensure the gold standard of science if we cannot get enough inspectors?
▶ 2:05:48Mr. Makary: Thank you for the question. I enjoyed our time in your office. I was not involved.
▶ 2:05:55Sen. Hickenlooper: That was not a criticism. Once you get the job, if your budget is diminished and you have 10% fewer inspectors and you already didn't have enough by existing measures, I'm not sure there is an answer for it. Maybe it is unfair.
▶ 2:06:14Mr. Makary: If confirmed you have my commitment that I will assess within the agency of personnel and it will be ongoing to ensure scientists and food inspectors have the resources they need to do their job.
▶ 2:06:28Sen. Hickenlooper: That is the place to start. We have a bill, skinny labels, big savings act that helps more generics, competition in the market, lower drug costs. With so many fda workers having been fired, will there be sufficient people to review generic applications?
▶ 2:06:55Sen. Hickenlooper: That often gets pushed to the bottom of the heap, yet it has dramatic savings especially for elderly and people who don't have insurance. Are you worried about a slowdown due to resources in personnel?
▶ 2:07:11Mr. Makary: I want to make sure reviewers and the review process is done properly without cutting corners on the scientific independence and done expeditiously. You have my commitment I will do my best to ensure, just to put things in context if I may. The fda has over 18,000 employees.
▶ 2:07:41Mr. Makary: That represents a 100% increase since '07. There were layoffs recently, I understand some or many were hired back. I want to let you know that to put things in context, we have seen a doubling of the agency since 2007.
▶ 2:07:59Sen. Hickenlooper: I accept that and was aware of that. Fairpoint. A lot of talk about measles. Secretary kennedy recommended the use of cod liver oil, one of several things people can do, left it to parents discretion as to whether they would get their kids vaccinated. I agree with that.
▶ 2:08:26Sen. Hickenlooper: Parents, in the end, have a right and responsibility to make that decision. It seemed there could be a stronger, those of us who looked in detail at the facts, that this is really a very safe vaccination for 99.9% of kids and it saves lives and prevents huge levels of very sick kids.
▶ 2:08:55Sen. Hickenlooper: Will you be willing to be a more enthusiastic supporter of vaccinations while at the same time recognizing parents get the final say?
▶ 2:09:02Mr. Makary: Vaccines save lives. I believe any child who dies of a vaccine preventable illness is a tragedy in the modern era. The rare times in which a child dies of measles was often in the setting of a comorbid condition or severe malnutrition and perhaps that is the rationale scientifically and physiologically as to why
▶ 2:09:33Mr. Makary: Supplementation of nutrients would provide benefit to children who are very sick and hospitalized with measles.
▶ 2:09:39Sen. Hickenlooper: I don't deny that.
▶ 2:09:41Mr. Makary: Thank you.
▶ 2:09:42Sen. Hickenlooper: Thank you for your service.
▶ 2:09:45Chair Cassidy: Senator cruz dead -- husted. >> great to have you before the committee. I enjoyed the conversation in my office. I wanted to give you the chance to share thoughts.
▶ 2:10:08Chair Cassidy: I am deeply concerned about how much inflationary cost the health care system has created for the american public in the last decade and in the 21st century we talk about inflation around here. The most inflationary cost affecting consumers, businesses, the american public/taxpayer's health care costs. We spend more and get worse outcomes.
▶ 2:10:36Chair Cassidy: From the earliest stages, we have children who are unhealthy, worse diets, obesity which lead to problems like diabetes, lower quality of life, lower productivity as they go through life, higher costs on the system, that continues to manifest through life on all those fronts and then the government and taxpayers end up paying for all of it through medicare/medicaid.
▶ 2:11:12Chair Cassidy: It is driving us to bankruptcy in some levels and costing families the ability to live, afford to live. How do we take cost out of the health care system, making people healthier and this system sustainable for the long run?
▶ 2:11:33Mr. Makary: It is good to see the cavaliers doing great this year. I hope this is their year to win it all.
▶ 2:11:45Sen. Husted: We only have one championship in cleveland.
▶ 2:11:52Mr. Makary: You are 100% correct. This is something I'm passionate about. Health care costs are spiraling out of control, burdening everyday american businesses and families and it is getting more difficult to compete with businesses overseas because of health care costs outpacing inflation and when we are spending money we don't have as a country it drives inflation and inflation is a backhanded
▶ 2:12:22Mr. Makary: Dirty tax on the poor. It does not affect the wealthy. It affects the poor. We have to address health care spending. We have heard many ideas out there. The main issue is the health of the population and it is getting worse. 75% of adults have some comorbid condition, diabetes, prediabetes, overweight or obese. Three in 10 teenagers have insol -- insulin resistance.
▶ 2:12:57Mr. Makary: For the first time we are talking about root causes on a research basis and what we can do it every agency. Within fda there are things we can do to help empower people by facilitating this independent scientific review of devices and other ways to prevent chronic diseases, with continuous glucose monitoring, blood pressure monitoring and healthy foods for children. If confirmed my goals are clear at fda.
▶ 2:13:25Mr. Makary: More cures and meaningful treatments for americans including diagnostics, healthy food for children and rebuilding public trust.
▶ 2:13:32Sen. Husted: I look forward to working with you on those issues. I'm sure many members of this committee do. One way we can drive more efficiency and speed market for things that can improve lives and hopefully lower cost is through technology. I was involved with the cleveland clinic when they got the first quantum computer focused on health care research, you use quanta and ai to drive discoveries, speed to market.
▶ 2:14:02Sen. Husted: Could you talk about how fda under your leadership would think about those things?
▶ 2:14:06Mr. Makary: There are opportunities with ai right now that we have that we have never had before. -- we have an incredible opportunity to help reviewers with the review process. Not to replace the human reviews, but to aid and assist in the same way that an ek -- ekg is read by ai devices that tell us normal sinus rhythm at the bottom.
▶ 2:14:34Mr. Makary: Now, we still look at the rhythm, but it aids and may help the efficiency among reviewers. We can use ai and drug design and development. It's not something that the fda does, but they can provide data to help train machine learning models to help design ai systems that can predict toxicities, adverse events, and even cures for some conditions.
▶ 2:14:59Mr. Makary: Finally, ai can be used for data monitoring in a postapproval setting so that we don't use -- don't learn five years after a drug is approved that 30 thousand americans died from it.
▶ 2:15:11Chair Cassidy: Thank you. Senator markey?
▶ 2:15:15Senator Markey: Thank you. Good luck to the cavaliers, I'm from the home of the celtics. [laughter] we'll have a little bet in june. You stated that you wanted to ensure that the fda holds the gold standard of trusted science and transparency. In order for that to happen, the fda commissioner must also uphold the gold standard for trusted science and transparency.
▶ 2:15:44Senator Markey: In your financial disclosures you disclosed he made half $1 million from global appropriateness measures llc. The client for that company includes companies interested in making money off of the health care system, insurance companies, hospital chains, private equity backed companies. Can you tell the committee how much you made from those private equity and venture capital backed companies?
▶ 2:16:11Dr. Makary: First of all, thank you for the question. I enjoyed our conversation prior to this hearing. I'm very proud of my work at global appropriateness measures. The purpose of the endeavor was to lower health care costs for americans by reducing unnecessary surgery and medications.
▶ 2:16:29Sen. Markey: I understand that. For the record, can you tell us how much you made from the private equity and venture capital backed companies?
▶ 2:16:38Dr. Makary: I have been a shareholder in global appropriateness measures. I don't have the exact numbers at my fingertips, but they were all disclosed to the office of government ethics and are all a part of the disclosure.
▶ 2:16:52Sen. Markey: Was it in the billions or less?
▶ 2:16:55Dr. Makary: Over what time?
▶ 2:16:57Sen. Markey: Over the time you had relationship with them.
▶ 2:17:00Dr. Makary: There was revenue of that company in the millions of dollars, yes, and I am one of the shareholders of that company and I am very proud. The best way to lower drug prices in the united states is to stop taking drugs we don't need. I do believe that the appropriateness of care in that endeavor was designed to create a software --
▶ 2:17:20Sen. Markey: I appreciate that. Just looking at the transparency issues. I'm trying to help you to be transparent here. How much were you paid by insurance companies, including devoted health services, an insurance company that primarily sells medicare advantage plans?
▶ 2:17:37Dr. Makary: That figure is at the office of government ethics. I don't have the exact number of my fingertips.
▶ 2:17:45Sen. Markey: Was that in the millions as well?
▶ 2:17:48Dr. Makary: No, far less. I'm a shareholder, so I, you know, I'm one of the shareholders of that company.
▶ 2:17:56Sen. Markey: I think the american people deserve your full transparency about how you might be influenced by the health care incident -- influence -- health care in -- health care industry and private capital. That's what I'm trying to get at.
▶ 2:18:14Dr. Makary: All of those reports will be public, senator.
▶ 2:18:17Sen. Markey: They are not at this point and that's why I'm asking you about them now.
▶ 2:18:21Dr. Makary: Government ethics will release it at a point in time.
▶ 2:18:24Sen. Markey: I appreciate that, but it's not helpful for the confirmation hearing, which is essential for the public understanding all of the potential, not actual, but potential conflicts of interest that might show up. The fda is responsible for approving medical devices and drugs that might impact how much insurance companies pay, for what they cover, in the same insurance companies that do overcharge americans and undercover their care, impacting hospital costs and private equity.
▶ 2:18:55Sen. Markey: You are coming into this role with relationships pre-existing that have a profit interest in the decisions that you will be responsible for making. That's why I'm raising these issues. Will you commit today to not participating in any decisions that would have an impact on known clients of global appropriateness measures during your tenure as fda commissioner?
▶ 2:19:21Dr. Makary: First of all, senator, I appreciate your enthusiasm on this topic. I am one of the biggest advocates that was involved in the health insurance industry transparency at the secret negotiated rates. I'm a big with you.
▶ 2:19:39Dr. Makary: The recusal's I will be taking our 100% in line with the office of government's recommendations, which were not to resign from everything, but I chose to resign from everything to make sure there was no appearance of conflict of interest.
▶ 2:19:54Chair Cassidy: Who you commit today to not participating in decisions that would have an impact on private equity and venture capital investors for those clients as well?
▶ 2:20:05Dr. Makary: I commit to following the office of government ethics commitment.
▶ 2:20:13Sen. Markey: It's so important for us to understand this going forward because of the increasing role that those sectors play. They will be attempting to influence fda decisions. It's the reason I'm raising the questions. Thank you, Mr. chairman.
▶ 2:20:31Dr. Makary: Thank you, senator.
▶ 2:20:36Chair Cassidy: [no audio]
▶ 2:20:43Dr. Makary: Thank you, senator. >> on that note, you have been very transparent?
▶ 2:20:51Dr. Makary: I believe so. >> how transparent do you have to be to get to this point?
▶ 2:20:56Dr. Makary: There was a massive disclosure of basically every single share of everything I owned. That process took a number of weeks. I would describe it as a colonoscopy with a small bowel file -- small bowel -- small bowel follow-through. I will have essentially no privacy when the office of government chooses to release that form. That's ok.
▶ 2:21:20Dr. Makary: I'm proud of everything I've done and am more than happy to acknowledge that I have agreed to divest and resign from everything. I was again given the option to not resign from everything and I chose to, because I want to ensure independence. This is not a job I'm taking to audition for my next job. This is a job I'm doing to serve the american public. I believe in more cures and meaningful treatments. Healthy food for children. Rebuilding the public trust.
▶ 2:21:50Dr. Makary: Senator, I can commit to you that I'm absolutely dedicated to that mission and I am not there to audition for a future job.
▶ 2:21:57Sen. Markey: I appreciate that. This is so important. You have been nominated because you are incredibly accomplished. Your background perfectly fits the role you are about to take and you bring experiences and success to the table to breathe new -- be the new head of the fda and change it. You talked about this. You mentioned in your testimony that health care has become too fragmented, cold, and corporate, right? You are going there to shake that up and change it.
▶ 2:22:29Sen. Markey: The make america healthy again movement that was a big part of giving this president a giant mandate with secretary kennedy and others coming to the table, the role you will play is really important to disrupting that. We all agree that -- I think the american people agree that the medical establishment is often condescending towards the american people in that is something we have to disrupt and change. How are you going to do that at the fda?
▶ 2:22:59Dr. Makary: I agree 100% that for the first time ever, trump and kennedy had to moms, republicans, democrats, independents come out and vote because they care deeply about the health of our nation's children. They want to see healthier food for children. They want to see in industry, and fda that is independent of corporate influence.
▶ 2:23:23Dr. Makary: At the same time, working with partnerships around the country to facilitate, not just to be in a receive only mode. One of my goals is to ensure that the fda maintains scientific integrity and that we can do what we can to contribute to the make america healthy again spirit.
▶ 2:23:42Sen. Hawley: Very good. Clinical and nonclinical testing are both important parts of the fda drug approval process. How do we modernize the process, modernize testing?
▶ 2:24:01Dr. Makary: There are steps in the regulatory process where we can take a look and ask if we have to use the same process we have been using. Infant formula, for example, has had the same recipe for the last 40 years. So, with the exception of selenium, added in 2015.
▶ 2:24:21Dr. Makary: For 40 years we required infant formula companies to use a standard recipe that was developed back when the food pyramid was misleading americans and basically government misinformation. Can we take another look at that? Can we create other ways in which new products could be brought to market safely? Can we look at real-world data from european products? The more competition, the more resiliency in the supply chain, the lower the risk of a shortage in the future.
▶ 2:24:52Dr. Makary: So, does infant formula need to go through the same process as a new drug? Or can we look at real-world data and work with companies to figure out a smarter way that uses both trusted science and common sense, a theme I would like to use.
▶ 2:25:07Sen. Hawley: I want to work with you on that. The fda is starting to allow patients to choose if they want prescription drug instructions digitally or on paper, but they are still required to be on paper. Would you support changing that requirement?
▶ 2:25:22Dr. Makary: My understanding is that that is a requirement set by congress and I would be more than happy to work with you and members of congress on that.
▶ 2:25:30Sen. Hawley: Opinion?
▶ 2:25:32Dr. Makary: I have heard arguments on both sides. One thing that people have raised is that on the one hand, it may be a waste of paper. It's a lot of paper. On the other hand, seniors may not go to the website to look at the information. There are arguments on both sides and I would welcome the opportunity to work with you on reform.
▶ 2:25:53Sen. Hawley: Thank you. I yield dashiell back.
▶ 2:25:57Chair Cassidy: Senator brooks?
▶ 2:26:02Senator: Good to see you here. I'm going to feed off of something I call he just said, that the medical establishment is condescending to the american people. I would like to offer that unfortunately, because this administration has been so reckless in the way that it has handled civil servants, I believe that they have been condescending to many of them as well and for the most part, many of them are my constituents who work in institutions like johns hopkins and who are serving the people.
▶ 2:26:31Senator: Many of the actions of this administration have been quite chaotic and confusing. I wanted to draw you too a few things. The committee staff read a memo last week put out by opm. The memo directed agencies to dramatically reduce staff. Then they reversed themselves.
▶ 2:26:49Senator: I'm not sure if you have seen the latest guidance from opm this week, which backtracked to the directive to fire employees and instead said that they should be clarified by saying that the decision to fire should be left to individual agencies. I would like to ask you, given the updated guidance, whether we have your assurance here today at this hearing that you will not arbitrarily fire employees at fda given the new guidance.
▶ 2:27:17Dr. Makary: First of all, senator, good to see you and I enjoyed our conversation. I'm very proud to work at johns hopkins in the state of maryland. I'm a big believer in the professional career staff at the fda, also located in maryland. You have my promise that if confirmed, I will do my own independent assessment on personnel. I welcome input on efficiencies at the agency.
▶ 2:27:47Dr. Makary: At the same time, I want to make sure that the scientists, food inspectors, and staff central to the agency have all the resources that they need to do their job well.
▶ 2:27:59Sen. Alsobrooks: As you mentioned, there are so many valuable members. Fda does such a tremendous service for our country. They handle drug safety, as you know. When we think about reviewing medical devices, and you mentioned infant formula, where the many women who are designated as the people who would make sure the items are safe are the ones who have been terminated. I would like to know if you would commit to rescinding the termination of scientists who were working, for example, to address the bird flu.
▶ 2:28:29Dr. Makary: I was not involved in any of those personnel decisions. If confirmed, I will certainly do an assessment.
▶ 2:28:37Sen. Alsobrooks: You'll go back and look at those terminations?
▶ 2:28:40Dr. Makary: Happy to, senator.
▶ 2:28:42Sen. Alsobrooks: Thank you. As well as the termination of individuals in the fda food division, the people that keep our food safe. You would commit them to going back and looking at those terminations to make an independent assessment?
▶ 2:28:56Dr. Makary: Of course Sen.
▶ 2:28:59Alsobrooks: , happy to.
▶ 2:28:59Sen. Alsobrooks: In the same vein, I wonder if you realize that many of the fda salaries are paid in large not by taxpayers, but by user fees. Are you familiar with that?
▶ 2:29:09Dr. Makary: Yes, I am.
▶ 2:29:11Sen. Alsobrooks: So, the concept that the reason to terminate these employees is to save taxpayer dollars is one based on a premise that is largely not true, since we use user fees for many of those salaries. That being the case, I wonder if you would commit then to rehiring the 100 employees who were fired from the fda tobacco center, which is 100% funded by user fees. Would you commit to going back and looking at rehiring the 100 who were terminated?
▶ 2:29:40Sen. Alsobrooks: If an employee has not logged on to their vpn in two years, I don't want to rehire them. But if there are people who deserve a look, I am of course having to look at that.
▶ 2:29:53Sen. Alsobrooks: There's a big lie out there that says that these civil servants are lazy, shiftless, and don't show up. By and large that's not true. I'm asking if you would go back and look at the ones who have been summarily terminated without cause. Your answer to that has been yes that you would go back and make an independent assessment.
▶ 2:30:11Dr. Makary: If confirmed, I will do assessment. Thank you.
▶ 2:30:16Sen. Alsobrooks: On tuesday, gsa through doge made a list of 400 buildings they want to dispose of, many of them on the white oak campus in maryland. Many of them are in a building called building number one. Are you familiar with building number one?
▶ 2:30:33Dr. Makary: I'm not familiar with the number of the buildings, senator.
▶ 2:30:37Sen. Alsobrooks: That's where your office would be. That's one of the buildings that doge has put on the list to shutter. Many of these decisions, pointing out, they are arbitrary and harm the american people. Would you be committed to making decisions that make sense and do not eliminate the fda?
▶ 2:30:57Dr. Makary: I believe in common sense and trusted science and if confirmed, you have my commitment to do an assessment of personnel, to look at efficiencies. I welcome the input of any organization, of any individual member of congress, from the administration and the doge team as well to figure out how the government can be more efficient.
▶ 2:31:18Sen. Alsobrooks: Thank you so much, doctor.
▶ 2:31:20Dr. Makary: Chair cassidy: thank you, senator. I would like to submit a washington post article referenced by an abortion survivor, melissa oden, regarding a woman who took mifepristone twice, taken outside of the 10 week indication limit. She still delivered her baby. Fda conducted safety studies on the product, I'm not aware that they have studied any safety outcomes related to a child that might still be born.
▶ 2:31:50Dr. Makary: As a physician, sending women abortion pills without a complete evaluation of the gestation of the pregnancy or checking for an ectopic pregnancy is clearly a safety issue. That is why I would urge Dr.
▶ 2:32:03Makary: To return to the policy that was placed during the first trump administration requiring in-person visits. With that, this concludes our hearing. I will just say that I know your family is incredibly proud of you and I thank them for being here as well. Believe me, you are here for a ride. Thank you for volunteering along with the doctor. Any senators wishing to ask additional questions, questions for the record will be due tomorrow at 5 p.m. This concludes the hearing.
▶ 2:32:32Dr. Makary: Thank you, Mr. chairman.