Hearings to examine the nomination of James O'Neill, of California, to be Deputy Secretary of Health and Human Services.

1[Senate Hearing 119-89]2[From the U.S. Government Publishing Office]34                                                         S. Hrg. 119-8956                      NOMINATION OF JAMES O'NEILL7                      TO SERVE AS DEPUTY SECRETARY8                      OF HEALTH AND HUMAN SERVICES910=======================================================================1112                                HEARING1314                                 OF THE1516                    COMMITTEE ON HEALTH, EDUCATION,17                          LABOR, AND PENSIONS1819                          UNITED STATES SENATE2021                    ONE HUNDRED NINETEENTH CONGRESS2223                             FIRST SESSION2425                                   ON2627EXAMINING THE NOMINATION OF JAMES O'NEILL, OF CALIFORNIA, TO BE DEPUTY28                 SECRETARY OF HEALTH AND HUMAN SERVICES2930                               __________3132                              MAY 8, 20253334                               __________3536 Printed for the use of the Committee on Health, Education, Labor, and Pensions3738                  [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]3940        Available via the World Wide Web: http://www.govinfo.gov4142                               ______4344                 U.S. GOVERNMENT PUBLISHING OFFICE454660-599 PDF                WASHINGTON : 20264748          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS4950                BILL CASSIDY, M.D., Louisiana, Chairman5152RAND PAUL, M.D., Kentucky            BERNIE SANDERS (I), Vermont,53SUSAN M. COLLINS, Maine                  Ranking Member54LISA MURKOWSKI, Alaska               PATTY MURRAY, Washington55MARKWAYNE MULLIN, Oklahoma           TAMMY BALDWIN, Wisconsin56ROGER MARSHALL, M.D., Kansas         CHRISTOPHER MURPHY, Connecticut57TIM SCOTT, South Carolina            TIM KAINE, Virginia58JOSH HAWLEY, Missouri                MAGGIE HASSAN, New Hampshire59TOMMY TUBERVILLE, Alabama            JOHN HICKENLOOPER, Colorado60JIM BANKS, Indiana                   ED MARKEY, Massachusetts61JON HUSTED, Ohio                     ANDY KIM, New Jersey62ASHLEY MOODY, Florida                LISA BLUNT ROCHESTER, Delaware63                                     ANGELA ALSOBROOKS, Maryland6465               Matthew Gallivan, Majority Staff Director66           Danielle Janowski, Majority Deputy Staff Director67                Warren Gunnels, Minority Staff Director68               Zain Rizvi, Minority Deputy Staff Director6970                            C O N T E N T S7172                              ----------7374                               STATEMENTS7576                         THURSDAY, MAY 8, 20257778                                                                   Page7980                           Committee Members8182Cassidy, Hon. Bill, Chairman, Committee on Health, Education,83  Labor, and Pensions, Opening statement.........................     184Baldwin, Hon. Tammy, U.S. Senator from the State of Wisconsin,85  statement......................................................     286Alsobrooks, Hon. Angela, U.S. Senator from the State of Maryland,87  Opening statement..............................................     288Thompson, Hon. Tommy G., Former Governor of the State of89  Wisconsin, statement...........................................     49091                               Witnesses9293O'Neill, James, Tiburon, CA......................................     494    Prepared statement...........................................     69596                          ADDITIONAL MATERIAL9798Statements, articles, publications, letters, etc.99Hassan, Hon. Maggie100    State of Maryland's complaint against Mr. Geier..............    27101102                        QUESTIONS FOR THE RECORD103104Response by James O'Neill to questions of:105    Senator Cassidy..............................................    82106    Senator Hawley...............................................    82107108                      NOMINATION OF JAMES O'NEILL109                      TO SERVE AS DEPUTY SECRETARY110                      OF HEALTH AND HUMAN SERVICES111112                              ----------113114                         Thursday, May 8, 2025115116                                       U.S. Senate,117       Committee on Health, Education, Labor, and Pensions,118                                                    Washington, DC.119    The Committee met, pursuant to notice, at 10:02 a.m., in120room SD-430, Dirksen Senate Office Building, Hon. Bill Cassidy,121presiding.122123    Present: Senators Cassidy [presiding], Marshall, Hawley,124Husted, Moody, Alsobrooks, Murray, Baldwin, Kaine, Hassan, and125Hickenlooper.126127                  OPENING STATEMENT OF SENATOR CASSIDY128129    The Chairman. The Senate Committee on Health, Education,130Labor, and Pensions will come to order. This morning, we're131having a hearing on the nomination of Mr. James O'Neill to132serve as the Deputy Secretary of Health and Human Services.133134    Actually, Senator Alsobrook, is substituting for Ranking135Member Sanders, she and I will both have opening statements.136Then former Wisconsin Governor and HHS Secretary Tommy137Thompson, will introduce our witness, although I think we're138going to have Senator Baldwin introduce Governor Thompson. Then139Mr. O'Neill will have 5 minutes for his opening statements and140Senators will then each have 5 minutes for questions.141142    Thank you, Mr. O'Neill, for being here and for your143willingness to serve. The Nation faces enormous health threats,144including rising healthcare costs, mental health and substance145use disorder crisis, a breakdown in public trust in healthcare146institutions, two high levels of chronic disease, and a147preventable measles outbreak, which has taken three lives and148hospitalized many others.149150    I will note that from 2000 to 2024, the United States saw a151total of three measles death. Now we've had three measles152deaths in just 4 months of this current outbreak. We should be153incredibly troubled.154155    The American people want solutions to make their lives156easier. They want results and not excuses. President Trump157working with Secretary of Health and Human Services, Kennedy,158has laid out a bold vision to make healthcare more affordable159and to make America healthy again. To do this, he needs160officials with the expertise and vision to carry out his agenda161while also increasing transparency, restoring trust, and162ensuring that science, not politics, drives decision-making.163This is why this nomination is so important.164165    If confirmed as Deputy HHS Secretary, Mr. O'Neill will be166responsible for implementing the President's agenda at HHS,167under Secretary Kennedy's leadership. He will help steer a ship168going through massive changes. The Deputy Secretary needs to be169someone whom Americans can trust to make science-based170decisions to strengthen HHS and to make America healthier.171172    I look forward to hearing your plans and vision to173accomplish this. Thank you for coming before this Committee and174being willing to serve. I look forward to discussing how we can175fulfill the vision of making America healthy again.176177    Senator Alsobrooks is not here, so walking in right now--178I'm looking out there and I don't see him walking in right now.179So, would you like to introduce the Hon. Governor?180181    Senator Baldwin. I'd be honored.182183    The Chairman. Please.184185               STATEMENT OF SENATOR TAMMY BALDWIN186187    Senator Baldwin. We have here today to introduce our188witness, Governor Tommy G. Thompson, the longest serving189Wisconsin Governor and one who prioritized the issues that this190Committee focuses on: health, education, labor, and pensions.191192    Not only did he serve his country as the Secretary of193Health and Human Services, and I remember fondly a dinner we194had together with Diana DeGette when I was in the house to195focus on biomedical research. But following that incredible196tenure of service, Tommy G. Thompson filled in as President of197our University of Wisconsin system, during a time of great198challenge, the pandemic, and was a champion once again of our199university system.200201    I'm just delighted to have you here. And would defer back202to the Chairman of the Committee to introduce our Ranking203Member for her opening statement.204205    The Chairman. Senator Alsobrooks.206207             OPENING STATEMENT OF SENATOR ANGELA ALSOBROOKS208209    Senator Alsobrooks. Thank you so much, Chairman Cassidy.210And for those who are wondering, I am not Bernie Sanders. I am211Angela Alsobrooks. Ranking Member Sanders is unable to be here212this morning, but I'd like to say a few words on behalf of the213Minority.214215    Today we are considering President Trump's nominee to be216the Deputy Secretary of Health and Human Services, Jim O'Neill.217We were also going to consider the President's nominee to be218the next Surgeon General of the United States, Dr. Janette219Nesheiwat, a Fox News medical contributor, and a graduate of220medical school, but for whatever reason, President Trump221abruptly withdrew her nomination yesterday afternoon.222223    As we all know; this is the second time that President224Trump has withdrawn a nominee within our Committee's225jurisdiction. In March, he withdrew the nomination of Dave226Weldon, who spent years lying about the safety and efficacy of227vaccines to head the CDC about an hour before his hearing was228set to begin.229230    At any rate, Mr. O'Neill, thank you so much, sir, for being231here today. And Mr. Chairman, I'd like to say that in America232today, we have a healthcare system that is broken, outrageously233expensive, and horrifically cruel. We also spend twice as much234per capita on healthcare as any other country on earth, over235$14,500 per year. And despite these huge expenditures, we236remain the only major country on earth not to guarantee237healthcare to all people as a human right.238239    Over 85 million Americans are still either uninsured or240underinsured. The result: over 60,000 people in our Country die241each year because they cannot afford to go to a doctor when242they should. More than half a million Americans go bankrupt due243to medically related debt, and one out of four Americans cannot244afford to buy the medicine their doctors prescribe.245246    Sadly, as dysfunctional as our current healthcare system in247America is, this Administration and many of my Republican248colleagues are actively working to make it worse. As we speak,249Republicans in Congress are writing a ``Reconciliation bill''250that would decimate Medicaid and throw millions of Americans251off the healthcare that they have in order to give huge tax252breaks to the wealthiest people and most profitable253corporations in America.254255    Let's be clear, when some of our Republican colleagues talk256about cutting Medicaid by up to $880 billion dollars, they are257talking about making devastating cuts to community health258centers, which rely on Medicaid for 43 percent of their259revenue, mostly children, and provide primary healthcare to 32260million people. They're also talking about cutting funding for261nursing homes, which depend on Medicaid for some two thirds of262their revenue.263264    Further, since the President has been in office, 20,000265employees at the Department of Health and Human Services have266been terminated or forced out, threatening the healthcare and267well-being of millions of Americans who rely on Head Start, the268Older Americans Act, Medicare, Medicaid, and LIHEAP.269270    My home State of Maryland has been reeling from these cuts.271Not only do we have over 150,000 dedicated Federal civil272servants in Maryland, but we are home to Federal health273agencies like NIH, FDA, SAMHSA, CMS, the Health Resources and274Services Administration, and AHRQ.275276    We need a Deputy Secretary of Health and Human Services who277will speak out against these devastating cuts and strongly278oppose decimating Medicaid. All of us want to make the279government more efficient, but we don't do this by slashing the280agency in charge of the health and well-being of tens of281millions of seniors, children, people with disabilities,282working families, and the most vulnerable people in our283Country.284285    We need a Deputy Secretary of Health and Human Services who286will fight, to continue healthcare as a human right, not as a287privilege, regardless of whether you are poor, working class or288wealthy.289290    Mr. O'Neill I have carefully reviewed your record and291background, and unfortunately, it is very clear to me that you,292sir, are not that person. And I'm concerned that you will be293just another rubber stamp for Donald Trump's rapid movement294toward the destabilization of our healthcare system. Thank you,295Mr. Chairman.296297    The Chairman. Thank you, Senator Alsobrooks. And now I298recognize Governor Thompson to introduce our nominee.299300  STATEMENT OF HON. TOMMY G. THOMPSON, FORMER GOVERNOR OF THE301                       STATE OF WISCONSIN302303    Honorable Thompson. Senator Cassidy, thank you very much304for allowing me to speak shortly and quickly about an305outstanding individual, my friend Jim O'Neill. I would like to306quickly add, that thank you for the very kind words from307Senator Baldwin, and I appreciate it very much. The good308Senator and I go back a long time with different political309parties, but we're still very close friends, and I thank you310very much for your very kind words. Appreciate it.311312    To all the distinguished Senators, thank you for giving me313this opportunity. Members of the HELP Committee, it's my314pleasure to introduce Jim O'Neill, President Trump's nominee to315be Deputy Secretary of the United States Department of the316Health and Human Services. I had the privilege of having Jim317work with me and for me when I was secretary of HHS. And based318on my experience, I can tell you that he's an excellent choice319to help manage this department.320321    He is a hard worker, a good listener, a brilliant thinker322and at HHS, he took the time to really learn the department,323and he gained a deep understanding of how HHS works. I can also324tell you that Jim is a compassionate person who cares deeply325about the mission of HHS. He's an evidence-based decision-326maker, and he cares and believes in good science.327328    Since his time in government, Jim has become an329entrepreneurial leader and a manager of complex businesses. He330has worked with and learned from some of the best and brightest331minds in business and in technology. He has a deep respect for332innovation and new ideas. He likes to make things work.333334    As the distinguished Members of this Committee know all too335well, our health system is broken, costs are too high, and336people are too sick. We need a health system that produces337better results for patients. And with all of these challenges338in mind, and Jim's highly relevant experience, I can tell you339and testify with great certainty that Jim O'Neill is an340outstanding choice for Deputy Secretary of HHS and will do the341job well, and you will all be proud of his effort.342343    Thank you very much, all of you.344345    The Chairman. Mr. O'Neill, you are recognized for your346statement.347348            STATEMENT OF JAMES O'NEILL, TIBURON, CA349350    Mr. O'Neill. Thank you so much, Governor. You've always351been a wonderful mentor and role model, and if confirmed, I352hope to live up to your record.353354    Good morning. Chairman Cassidy, Senator Alsobrooks,355distinguished Members of this Committee: thank you so much for356inviting me to talk with you today.357358    Imagine every American waking up, vibrant, energetic, and359free of disease. That's President Trump's vision to make360America healthy again. And I'm honored to be nominated to help361turn it into reality. I'm grateful to Secretary Kennedy for his362bold leadership and for his trust in my experience to deliver363results. My children, Eve, Sebastian, and Cecily, are in school364in California today, but they're why I'm here: I want them and365every child to inherit a healthier nation.366367    Mr. Chairman, I believe that all Americans deserve to be368healthy, happy, and prosperous. Most families try to make369healthy choices, but our food system pushes ultra processed370foods. Our official nutrition advice creates confusion. Our371healthcare system is difficult to navigate, and it prioritizes372pills over prevention.373374    Providers spend too much time clicking through pop-up375screens and fighting with insurance companies, instead of376looking patients in the eye. Federal policies can empower377people to break this cycle. If confirmed, I'll help reform378outdated rules, pursue transparency in gold standard science,379and champion healthy lifestyles and prevention so Americans can380thrive.381382    For three decades, I've worked to improve healthcare. As a383Senate staffer in the 1990's, I helped Senators shape384bipartisan reforms, including HIPAA-collaborating with385lawmakers to protect patient privacy.386387    During the Bush administration, I had the pleasure of388working at HHS for 6 years with Secretary Thompson, Secretary389Mike Leavitt, and thousands of talented career and appointed390colleagues. I'm proud of my work there, and I learned a great391deal about the responsibility structures and dedicated392professionals of each of the operating divisions of the393department, and how those divisions can best serve the American394people and improve their health and welfare.395396    At HHS, I helped Congress pass the Medicare Modernization397Act, modernize FDA, and strengthen food safety. I improved398preparedness for avian influenza and hurricanes by helping399establish the Administration for Strategic Preparedness and400Response after it was authorized by Congress. I conducted401health diplomacy, by visiting allied countries and working with402ministers of health. I served on the President's Management403Council and led HHS to earn the highest possible management404score.405406    Most recently in California, I've partnered with407entrepreneurs to advance cutting edge research, technologies,408and therapies. And this experience has reinforced my conviction409that government must support, not hinder innovators to deliver410effective and affordable results that get better every year.411I've seen what happens when you pair the brightest minds with412the best tools and data, and we must bring that same dynamism413into government.414415    Sadly, America's health is in crisis. Three quarters of416Americans are overweight or obese, leading to chronic diseases417like diabetes, high blood pressure, and over time heart attacks418and kidney failure. Diabetes alone costs us $400 billion every419year, and has exploded in prevalence tenfold since 1960.420421    Fentanyl ravages our cities and our countryside. Addiction422and mental health are urgent unsolved problems. Since 2000,423suicide has increased by 37 percent. Medicare hospital424insurance is headed toward insolvency. Families struggle to425afford individual insurance. We spend $4.7 trillion on426healthcare-double the OECD average, yet our life expectancy is427actually shorter than it was in 2010. These aren't just428numbers. There are a call to action. Overall, what we're doing429is just not working.430431    That's why I'm so grateful to President Trump and Secretary432Kennedy for taking on these challenges and promoting a vision433for change. Mr. Chairman, we have a century scale opportunity434to act. If confirmed, I'm eager to rejoin HHS and: reform our435food system to prioritize health for our children and parents,436pursue gold standard basic and translational research that437replicates, use science, economics, and artificial intelligence438to improve the quality and affordability of healthcare, and439accelerate development and access to lifesaving and health440extending treatments.441442    I'm ready to work with this Committee, to make a443generational change in our Nation's health. For my children,444for our families, and for every American, I pledge to fight for445a future where everyone can enjoy a long, vigorous, and446prosperous life. I look forward to your questions.447448    [The prepared statement of Mr. O'Neill follows.]449450                  prepared statement of james o'neill451    Good morning. Chairman Cassidy, Ranking Member Sanders, and452distinguished Members of this Committee: thank you for inviting me to453appear before you today.454455    Imagine every American waking up vibrant, energetic, and free of456disease. That's President Trump's vision to make America healthy again,457and I'm honored to be nominated to help turn it into reality.458459    I'm grateful to Secretary Kennedy for his bold leadership and for460his trust in my experience to deliver results.461462    My children Eve, Sebastian, and Cecily are in school in California463today, but they're why I'm here: I want them, and every child, to464inherit a healthier nation.465466    Mr. Chairman, I believe that all Americans deserve to be healthy,467happy, and prosperous. Most families try to make healthy choices, but468our food system pushes ultra-processed foods, our official nutrition469advice creates confusion, our health care system is difficult to470navigate and it prioritizes pills over prevention. Providers spend too471much time clicking through popup screens and fighting with insurance472companies instead of looking patients in the eye. Federal policies can473empower people to break this cycle. If confirmed, I'll help reform474outdated rules, pursue transparency and gold standard science, and475champion healthy lifestyles and prevention so Americans can thrive.476477    For three decades, I've worked to improve health care. As a Senate478staffer in the 1990's, I helped Senators shape bipartisan reforms479including HIPAA--collaborating with lawmakers to protect patient480privacy.481482    During the Bush administration, I had the pleasure of working at483HHS for 6 years with Secretary Tommy Thompson, Secretary Mike Leavitt,484and thousands of talented career and appointed colleagues. I am proud485of my work there, and I learned a great deal about the486responsibilities, structures, and dedicated professionals of each of487the operating divisions of the Department, and how those divisions can488best serve the American people and improve their health and welfare.489490    At HHS, I helped pass the Medicare Modernization Act, modernize the491FDA, and strengthen food safety. I improved preparedness for avian492influenza and hurricanes by helping establish the Administration for493Strategic Preparedness and Response after it was authorized by494Congress. I conducted health diplomacy by visiting allied countries and495working with ministers of health. I served on the President's496Management Council and led HHS to earn the highest possible management497score.498499    Most recently, in California, I've partnered with entrepreneurs to500advance cutting-edge research, technologies, and therapies, and this501experience has reinforced my conviction that government must support,502not hinder, innovators to deliver effective and affordable results that503get better every year. I've seen what happens when you pair the504brightest minds with the best tools and data, and we must bring that505same dynamism into government.506507    Sadly, America's health is in crisis. Three quarters of Americans508are overweight or obese, leading to chronic diseases like diabetes,509high blood pressure, and over time, heart attacks and kidney failure.510Diabetes alone costs us $400 billion every year, and it has exploded in511prevalence tenfold since 1960. Fentanyl ravages our cities and our512countryside. Addiction and mental health are urgent unsolved problems.513Since 2000, suicide has increased by 37 percent. Medicare hospital514insurance is headed toward insolvency. Families struggle to afford515individual insurance. We spend $4.1 trillion on health care--double the516OECD average--yet our life expectancy is actually shorter than it was517in 2010. These aren't just numbers; they're a call to action. Overall,518what we've been doing is just not working.519520    That's why I am so grateful to President Trump and Secretary521Kennedy for taking on these challenges and promoting a vision for522change.523524    Mr. Chairman, we have a century-scale opportunity to act. If525confirmed, I'm eager to rejoin HHS and:526527          reform our food system to prioritize health for our528        children and parents;529530          pursue gold-standard basic and translational research531        that replicates;532533          use science, economics, and artificial intelligence534        to improve the quality and affordability of health care; and535536          accelerate development and access to life-saving and537        health-extending treatments.538539    I'm ready to work with this Committee to make a generational change540in our Nation's health.541542    For my children, for our families, and for every American, I pledge543to fight for a future where everyone can enjoy a long, vigorous, and544prosperous life.545546    I look forward to your questions.547                                 ______548549    The Chairman. Thank you, sir. I'll start. You worked on550HIPAA in your previous work. I think HIPAA needs to be updated.551AI, I think has the ability to exploit. Can you have any552thoughts on that or how would you potentially work with us--553what are your thoughts along those lines, please?554555    Mr. O'Neill. Yes. Thank you. So, I was at HHS during the556promulgation of the HIPAA privacy rule, which was led by the557Office of Civil Rights. I was not at the center of that558discussion, but I was on the periphery. I definitely strongly559support the principle of medical privacy. Patients' private560health data needs to remain private, needs to only be shared561with people that they consent to be sharing to.562563    AI, as I said, has tremendous potential to improve564healthcare across the board and improve the functions of the565department. But yes, of course, we need to periodically review566the HIPAA privacy rule and make sure that it is not leaving567patient data open to threats because of AI.568569    The Chairman. It does seem like AI could do a lot of570things, for example, my search history or my watch. Because571I've had legislation regarding that-bipartisan, which would be572very impactful upon somebody deciding whether to hire me.573Should we have a broader definition of what is protected health574information?575576    Mr. O'Neill. That seems like a reasonable thing to consider577as we look at the privacy rule. I'm not sure the privacy rule--578Well, you might know more than I do, I don't think employers579have any current legal access to health records.580581    The Chairman. Not only health records, but I was told once582by someone who is a headhunter that he can somehow access583people's search history. And if someone is looking for in vitro584fertilization, for example, would tell the potential employer,585oh, this person's investigating IVF, she may be--you see where586I'm going with that.587588    Mr. O'Neill. That does sound like a significant concern.589And if confirmed, I'd be happy to make sure that the HIPAA590privacy rule is up to date with regard to AI and, and whatever591is necessary, both legally and technologically, to ensure that592patient's data is not shared anywhere without their consent, as593well as search history and other related things.594595    The Chairman. You and I have discussed immunization596mandates, and you've mentioned that you--am I correctly597characterizing your view, you support immunization, but you598don't think the Federal Government should mandate rather, that599decision should be held to localities?600601    Mr. O'Neill. Yes. Senator.602603    The Chairman. Right now, for someone who wishes to become a604permanent resident in the United States, it is mandated that605they be up to date on CDC recommended vaccines. Frankly, we606don't mandate for that, for those people who come across the607border illegally, and are then transmitted into the interior of608the country. And I've gathered that a lot of the measles that609we're seeing right now, for example, in my state in New610Orleans, is coming from people coming to our Country from611elsewhere and bringing measles with them.612613    First, do you agree that the Federal Government should614mandate that if someone becomes a U.S. citizen, that they'd be615up to date on their immunizations?616617    Mr. O'Neill. Senator, as you know, I'm very strongly618practicing pro-vaccine. I'm an advisor to a vaccine company. I619support the CDC vaccine schedule. I mean, I think by620definition, illegal immigrants are not passing through any kind621of checkpoint that could check for their vaccine.622623    The Chairman. But when they're arrested, if you will,624detained, they're brought to an area which HHS has a role in,625and they receive medical services, screened for tuberculosis,626that sort of thing, and then passed through. So, there is a627role that HHS has in making sure that these folks are safe. And628yet we see measles being introduced in our Country by people629who are from outside our Country.630631    First, would you accept a mandate? Do you agree with the632mandate which currently exists, that if somebody wishes to633become a legal resident, that they'd be up to date on their634immunizations as per recommended by CDC?635636    Mr. O'Neill. I haven't looked into the immigration law637aspect of this, but I do support the CDC schedule and that rule638seems reasonable.639640    The Chairman. This is about the mandate?641642    Mr. O'Neill. Yes, I understand. I said that rule seems643reasonable to me.644645    The Chairman. Then what about those who are coming? Because646frankly, since we have measles coming to our Country, from647people from outside, it seems relevant to me. I would like to648say, wait a second. If you're coming to our Country, we don't649expect you to bring disease, and we expect you therefore to be650up to date on your immunizations.651652    Does your opposition to mandates on a Federal level, would653it extend to that sort of--would you oppose that sort of654mandate? Because if you come here legally, you got to get it655right. The crazy thing is if you come here illegally, you don't656have to get it, which just doesn't make sense to me.657658    Mr. O'Neill. Senator, I think President Trump's been very659successful at controlling the border at significantly----660661    The Chairman. Yes. But there'll be a future President.662663    Mr. O'Neill. Sure.664665    The Chairman. We're establishing law now for future666Presidents, not just our own.667668    Mr. O'Neill. Well, I think future Presidents could not only669change border enforcement, they could also change the rules for670naturalization and for what kind of medical requirements are671put on legal and Illegal records.672673    The Chairman. I'll come back to that maybe at the very end.674675    Mr. O'Neill. Okay. Sure. Thank You, Senator.676677    The Chairman. Senator Alsobrooks----678679    Senator Murray.680681    Senator Murray. Thank you very much, and thank you for the682accommodation. And Mr. Chairman, I just want you to know, the683Trump administration fired many of the CDC Port Health Station684staff. In fact, at SeaTac in my state, there used to be four.685They are the persons that screen travelers at the ports of any686entry. So, if we don't have people there to screen, even a687mandate would make it very difficult to assure that. So, I688share your concern, but I also think we have to have personnel689there to do it.690691    With that, Mr. O'Neill we know right now that at HHS,692they're undertaking a massive reorganization, firing staff,693canceling, and terminating thousands of grants and contracts694worth billions of dollars, delaying sending that grant funding695out, including, by the way, for lifesaving biomedical research.696697    Meanwhile, HHS is currently, and I know you're not there698yet, but they're refusing to provide basic answers to many of699our straightforward questions. They're canceling longstanding700briefings, and they're telling Congress and virtually the701American public nothing about these dramatic, unprecedented702changes.703704    Last week, HHS submitted an operating plan for fiscal year70525 required by law, and it leaves it blank. The funding levels706for 530 programs were left blank. The department is effectively707telling us, it doesn't have to tell us or the American people708anything, about how it is going to spend tens of billions of709dollars, taxpayer dollars across hundreds of programs. And that710is really stunning to me.711712    In my time in Congress, I have never seen an Administration713less transparent than this one. I've also never seen an714Administration so insistent on pretending they are transparent715while going out of their way to hide basic information that we716require.717718    Mr. O'Neill. I want to ask you, if you are confirmed, will719you commit to prioritizing real transparency and sharing720information with Congress and the American public about what721HHS is doing?722723    Mr. O'Neill. Thank you for the questions, Senator. It's724lovely to see you. I was a Senate staffer in the 1990's. We had725a few pleasant interactions. I don't expect you to remember.726But yes, I have a kind of visceral sense that it's Congress727that authorizes all the programs at HHS, it's Congress that728appropriates the money for HHS. Congress absolutely deserves to729have prompt and accurate information, both proactively about730future plans and also in reply to questions, whether it's731testimony or written questions.732733    Yes, I commit if confirmed to ensure that the whole734department takes seriously its obligation to provide good,735transparent, accurate, prompt information to Congress.736737    Senator Murray. Well, I appreciate that answer. I'm not738holding my breath because I haven't seen it happen yet. But Mr.739Chairman, I want you to know I am focused on real transparency740here. This department is not above Congressional oversight. And741we have a responsibility and a need to hold all the agencies742accountable. So, this is something I'm tracking very closely.743744    I wanted to ask you quickly too about women's health. The745plan to gut HHS is a disaster for health and safety, but it is746based, it seems to me, on a total lack of understanding about747how different agencies across the department work. For example,748Senator Kennedy, seems to think we shouldn't have more than one749office that covers women's health. Well, women's health750requires dedicated focus in different areas, for example;751workforce training at HRSA, cancer prevention at CDC,752scientific research at NIH. Those are separate and distinct753efforts addressing women's health, which has long been754underfunded. But because of Congress's dedicated bipartisan755investments, we've been able to make progress.756757    If you are confirmed, will you commit to restoring women's758health functions across HHS, and directing the department to759spend appropriated funds for women's health as directed by760Congress?761762    Mr. O'Neill. Thank you for the question, Senator.763Obviously, women's health will continue to be a critical issue.764It is distinct from Men's health in many significant ways.765766    The principles of the secretary outlined for the proposed767reorg, said that any reorg would be based on preserving all the768central functions of the department, ensuring that they769continue and that they're executed on well as mandated by770statute, and also the principle that two functions make more771sense to be conducted within the same agency or office, that772could make sense. It also makes sense to me that if functions773are closely similar, perhaps we should consider putting them in774the same office.775776    Senator Murray. Well, I would just say, Mr. Chairman,777women's health isn't just one little corner. We are affected--778women are affected in many different ways, including, as I779said, through workforce training, through cancer prevention,780through scientific research, different agencies. Those offices781all do very different things. There's a reason why Congress782passed funding for each one of them. Ignoring that means783ignoring the law. Thank you, Mr. Chairman.784785    The Chairman. Senator Moody.786787    Senator Moody. Thank you, sir. Thank you for being here.788And if I might just say thank you to your family. Senator789Houston and I are the two newest Members of the U.S. Senate,790and our families are also serving. It is certainly a family791sacrifice, and I'm so grateful you're willing to come back in792to public service using all that you have acquired both in your793government service and your private experience to benefit794Americans and their health. So, thank you very much.795796    As Deputy Secretary, you will oversee the operations of the797department, from the FDA to Office of Refugee Resettlement,798including many actions related to the regulatory side of the799department. I wanted to talk to you about some issues certainly800as a mother and as the former Attorney General of Florida that801I saw not handled well at all in, in fact, it was a disaster802under the Biden administration.803804    I wanted to get your take on how you might approach making805sure that it can never happen again, and any regulations or806oversight is considered and modified within the agency to make807sure it never happens again.808809    Specifically, we saw that when Biden opened up the border810and destroyed any semblance of security, we saw many, many811young minor children smuggled into our Country, pushed into812states throughout. The office of Refugee Resettlement was813supposed to oversee this. It got so bad that they lost tens of814thousands of children.815816    In Florida, we could get no information from the Biden817administration on who these children were, where they were818being placed, how they were being taken care of. Even though819the states have a primary responsibility of dealing with820neglected, abandoned, abused children, no information was821shared.822823    In order to remedy that, we went so far as to launch a824grand jury investigation. And when we asked for Administration825officials to come down and testify or share information, they826refused to do so, they said that it was hard to see how it827would benefit the agency. When all we cared about was the828interest of those children who not only were smuggled into the829United States. Our grand jury report showed that they had been,830some had been sent to strip clubs, empty lots next to container831facilities, dozens placed with the same sponsor, many unvetted,832it was inviting trafficking. In fact, many children in the833United States were found to have been in trafficking that had834been smuggled over the border.835836    I believe and I believe the Grand Jury report shows that837this obfuscation, or refusal to provide information or838witnesses was to shield the fact they knew these kids were not839being supervised, being put in dangerous situations, and they840were, in fact, the Administration, in fact, was facilitating841trafficking.842843    What will you do, knowing that the Office of Refugee844Resettlement is going to be in terms of operations, is going to845be under your purview? What will you do to ensure--Now again,846we know that in the first 100 days, President Trump has847basically shut down the border. We're seeing nothing like the848numbers we saw last year. My hope is that this stops. The849purposeful smuggling of children into our Nation being put into850dangerous situations, that we shut this down.851852    What can you do to ensure that this never happens again? As853a mother, but certainly as the Attorney General that was854working with agencies desperately trying to promote safeguards855for children, not getting any information, law enforcement was856begging for it. Child Services was begging for it. What will857you do to ensure that this can't happen again?858859    Mr. O'Neill. Thank you for the excellent question, Senator860Moody. So, in the Bush administration, I worked very closely861with the Office of Refugee Resettlement, especially to fight862human trafficking. I was the HHS representative on the863government wide senior policy and operating group to fight864human trafficking. I'm very proud of the work that we did with865ORR at that time. The focus ORR was a little bit different866then, the human trafficking fight was not as focused on the867border as it obviously has been in the last 5 years.868869    It is absolutely a priority, and I believe the Secretary870has set it as a priority for him to find all the missing871children and make sure that they're safe. And if confirmed, I872look forward to working with him and the Office of Refugee873Resettlement, as well as other parts of government to ensure874that all children are safe.875876    Senator Moody. Well, again, remember, it's not just finding877these children. There are regulations in place that facilitated878the government basically becoming traffickers of children. Can879you go in and work immediately to remedy any of those that880either promoted or allowed for these children to be881disseminated across the United States, many never to be heard882from again, placed in incredibly dangerous situations?883884    Mr. O'Neill. Yes, I can. So traditionally, the role of885Deputy Secretary is heavily focused on regulations, on making886sure that regulations are up to date and appropriate and making887modifications when necessary. And I will absolutely review all888the regulations pertaining to ORR or any other areas that could889affect trafficking or missing children and make sure that890they're appropriate. Thank you,891892    The Chairman. Senator, Alsobrooks.893894    Senator Alsobrooks. Thank you so much. Thank you so much895Mr. O'Neill for being here today. And for your Interview, 20896years ago, that there were studies looking at how much lasting897value Head Start gave to children. And I quote that you said898you don't have an updated view on how efficacious it is. You899said also that you didn't have a view on the Head Start program900at this time.901902    I have to tell you, Mr. O'Neill, that's a really concerning903answer from the person who is interviewing to be leader at the904department, and whose purview will not only be health programs,905but the Human Services program that serve our children's, our906Nation's children, and families. As the Deputy Secretary, you907will be responsible for helping develop the budget request for908programs like Head Start, which is an extremely important909program for so many children and their families and divisions910like the Administration for Children and Families.911912    My first question is, given your remarks just this last913past week on Friday, regarding not having an updated view on914Head Start. Have you now today, do you have a more--have you915familiarized yourself with the Head Start Program since that916discussion? And do you know how many children are even served917by the Head Start program?918919    Mr. O'Neill. Thank you for the question, Senator. And by920the way, I really enjoyed our conversation in your office a few921weeks ago. I have not had any input into any discussions about922reorganizations or budget. If confirmed, of course, I would be923happy to, and responsible for digging into every element of924reorganization and budget around all HHS programs. Currently,925I'm a private citizen.926927    Regarding measles, Senator, as you know, the measles928outbreak began before Secretary Kennedy took office. Since he's929taken office, he has recommended the MMR vaccine to parents,930multiple occasions, including on television. He's also deployed931a CDC task force to Texas and other locations, to take charge932of the measles outbreak. I think both of these actions are933extremely appropriate. I think he's taking measles seriously as934he should. And I support all of that. I support the MMR935vaccine, I support deploying----936937    Senator Alsobrooks. With all due respect, I only have938another minute. Let me just ask you, Mr. O'Neill, I'm going to939be able to talk to the secretary, I hope next week. I don't940agree that he's taking Measles seriously at all. But I needed941an answer from you. It's important for us to know what you942think about Head Start. And so, I'd just like you to tell me943whether or not you still believe, you're not sure, whether or944not Head Start it's efficacious as you put it.945946    Mr. O'Neill. Senator, it's essential that children in early947childhood have good appropriate care and cognitive development.948I don't know the best way to do that. It may well be Head949Start. I have not been involved in any discussions around950reorganizing it or moving it or anything like that. If951confirmed, of course, I would be.952953    Senator Alsobrooks. Okay. And again, this program is so954important, and when the Administration first announced its955funding freezes, Head Start providers were locked out of a956portal. This is of course, devastating. And many didn't know if957they'd be able to even make payroll or continued to operate.958959    If confirmed, can you commit that the department will send960all Head Start Awards to providers on time, and that this sort961of chaos won't continue to resurface regarding Head Start? We962just need a clear answer about what you intend to do with Head963Start.964965    Mr. O'Neill. Senator, I've never been a fan of chaos. I966intend to do my best if confirmed to ensure that there's no967chaos in the department or in any part of the department.968Payroll should be always paid on time. And if the department969has made any mistakes, of course it should correct them.970971    Senator Alsobrooks. Would that include reinstating the972staff who administer the Head Start program and reopen the973closed regional offices that are responsible for overseeing974Head Start programs?975976    Mr. O'Neill. Senator, I haven't been involved in any of977those discussions. I would say that making sure there's the978right number of people with the right skills in every division979of HHS would be a responsibility.980981    Senator Alsobrooks. Thank you. Thank you, Mr. Chairman.982983    The Chairman. Senator Husted.984985    Senator Husted. Thank you, Mr. Chairman. Thank you, Mr.986O'Neill, for your willingness to serve and provide testimony987today and answer our questions. I look forward to working with988you and the Secretary to improve health outcomes. You do a very989important job.990991    President Trump recently issued an executive order this992week that would prohibit Federal funding for potentially993dangerous life science research, such as gain-of-function994research, in adversarial countries of concern. For example,995China, which is home of the Wuhan Institute of Virology, and996the SARS-CoV-2 coronavirus that killed people around the world,997closed schools, cost this government at least $5 trillion and998left a wake of devastation behind it. Sometimes small things999can cause big problems, and this is certainly a case where it1000did.10011002    I applaud the Administration for these efforts, I think1003it's an excellent step to keep Americans and the world safe and1004prevent the next pandemic. And I am concerned about1005unsupervised high-risk research right here at home though.10061007    Specifically, I am concerned about what we can do to1008protect against the misuse of desktop gene synthesizers. I am a1009fan of innovation in technology and healthcare. It can do1010amazing things, and these devices have the potential to do good1011to advance research. They could also though, provide genes for1012deadly pandemics, either to state actors or terrorists, and1013could be used as a bio weapon. And unlike most commercial gene1014sequence providers, a terrorist group or state actor could1015synthesize a deadly pathogen with no screen or safeguards in1016place.10171018    Looking at this issue through your role and through the1019Department of Health and Human Services, what can you say to us1020today that can provide some reassurance or guidance on the1021framework for how nucleic acid screening captures of a desktop1022gene synthesis and researching, occurring outside of the1023commercial gene census providers, how will you help make sure1024that this is done safely and responsibly in the United States?10251026    Mr. O'Neill. Thank you for the excellent question, Senator.1027Gain-and-function research imposes risks on the entire world.1028And so, it is not a simple matter of if the money could better1029be spent elsewhere. It is a matter of should this research be1030done at all, and how to account for the fact that it might be1031conducted in other countries that we have little influence1032over. Of course, it's appropriate to research on viruses and1033microbes so that we are ready to respond to a pandemic1034regardless of whether it's naturally occurring or manmade.10351036    But extending that research into gain-of-function research1037is a totally different level of risk. My understanding is that1038there was an NIH ban on gain-of-function research that I1039believe the Obama administration lifted or weakened during its1040last weeks before leaving.10411042    Obviously, there's evidence that efforts were made by1043various scientists to evade even the rules that existed. It1044does look like NIH money made its way into some gain-of-1045function research. And if so, that strikes me as completely1046inappropriate and something we should work on.10471048    You also mentioned desktop generation of genes. That is a1049concern. Overall, I think sophisticated technology is mostly1050going to be very beneficial. Artificial intelligence, machine1051learning, large language models, neural networks. But of1052course, there is potential danger as well, regulation might be1053appropriate. One thing I've noticed with regulation of cutting-1054edge science is the regulation struggles to be as up to date as1055the technology.10561057    I would like to recruit very excellent technologists into1058the department in all divisions to ensure that anything we do1059to address the risks of gain-of-function research has an up-to-1060date technology side as well as regulatory side.10611062    Senator Husted. Thank you. And I'll just add this. With1063quantum computing, AI essentially 3D printing types of1064technologies that are going to allow us to do some amazing1065research on health solutions. I just ask that we make sure1066we're doing all that is possible to ensure that it's not used1067for nefarious purposes, because we have seen what happens when1068either through sinister reasons or through incompetency, it can1069definitely have a major impact on our world. Thank you, Mr.1070Chairman.10711072    Mr. O'Neill. Thank you, Senator.10731074    The Chairman. Senator Baldwin.10751076    Senator Baldwin. Thank you, Mr. Chairman. And Mr. O'Neill,1077thank you for our opportunity to speak prior to this hearing. I1078share the deep concern expressed about Health and Human1079Services submitting an operating plan, otherwise known as a1080spend plan to Congress that includes asterisks, rather than1081planned funding levels for over 530 different programs. This is1082effectively the Department of Health and Human Services saying1083that it doesn't need to tell Congress and the American1084taxpayers how it is spending tons of billions of dollars.10851086    With that, we are left to assume that the Department of1087Health and Human Services is intentionally hiding what it's1088doing, and the results of a massive proposed reorganization,1089firing of tens of thousands of employees, terminating billions1090of dollars in grants and actively delaying billions of dollars1091in funding.10921093    During our meeting, we discussed the importance of1094transparency. Secretary Kennedy has pledged what he called1095radical transparency, and that is absolutely not what we have1096seen. So, Mr. O'Neill, do you think that the Department of1097Health and Human Services should tell Congress and the American1098public how it is spending taxpayer dollars that we have already1099appropriated, yes or no?11001101    Mr. O'Neill. Thank you for the question, Senator. I also1102enjoyed our meeting. So, I've not seen this plan that you're1103referring to with the asterisk----11041105    Senator Baldwin. I can tell you that it was a long page1106asterisks, asterisks, asterisks, no dollar amount, except for a1107handful of programs. That is not radical transparency in my1108book. Should the Department of Health and Human Services tell1109Congress and the American public, if it is, for example,1110cutting funding for services through the 988 Suicide and Crisis1111Lifeline, yes, or no?11121113    Mr. O'Neill. Senator, I'm a former Senate staffer. I, I1114know that it's Congress that authorizes all the programs at1115HHS, it's Congress that appropriates the money for HHS,1116Congress absolutely deserves prompt and transparent and1117accurate information. I stress the prompt part.11181119    Senator Baldwin. What about how many employees have been1120fired and the functions that those employees were carrying out,1121should that be reported to Congress and the American taxpayers?11221123    Mr. O'Neill. Senator, my understanding of the--is that it1124was the decisions of who to lay off were, I think I read, made1125by the heads of the operating divisions who are closer----11261127    Senator Baldwin. Should that be reported to Congress?11281129    Mr. O'Neill. Senator, yes. I think so.11301131    Senator Baldwin. Okay. Should the Department of Health and1132Human Services tell Congress if it fired, for example,1133employees administering clinical trials at NIHs clinical1134Center? Yes, or no?11351136    Mr. O'Neill. Senator, I think every significant thing the1137department does should be available to Congress.11381139    Senator Baldwin. Mr. O'Neill, if you are confirmed, I will1140certainly be following up to ensure that Health and Human1141Services makes good on the commitment to transparency. And if1142these changes would actually enhance the health and well-being1143of Americans, HHS should be eager to explain how and why1144instead of what it's doing, which is hiding this information.11451146    HHS has delayed funding for research on treatments for1147deadly diseases and for Head Start and childcare programs. It's1148decimated offices responsible for carrying out critical1149activities, including addressing lead poisoning in children.11501151    Let me just give you an example of how HHS firings are1152impacting communities in Wisconsin. The city of Milwaukee1153requested assistance through the CDC's Childhood Lead Poisoning1154Prevention Surveillance Branch, to help respond to lead1155poisoning cases tied to several public-school facilities. The1156request for assistance was denied because of a lack of staff1157capacity after the entire childhood lead poisoning branch was1158fired. This is a clear example of HHS firing affecting critical1159program operations.11601161    Without the support, Milwaukee faces lasting implications1162of health and well-being of children in the city. If you are1163confirmed, I will be following up with you on this, as I have1164yet to receive a response from Secretary Kennedy.11651166    The Chairman. Senator Marshall.11671168    Senator Marshall. Thank you, Chairman. And welcome Mr.1169O'Neill. It's good to see you again. I was excited yesterday to1170see the nomination for President Trump of Dr. Casey Means to be1171the Surgeon General, and certainly she is an expert on all1172things MAHA and nutrition and metabolism importance of1173mitochondria. And I want to relate that to what you mentioned1174in your testimony that you're anxious to reform our food system1175to prioritize health. And just kind of tell me what that vision1176looks like and how can you work with Dr. Means and the other1177folks there at HHS?11781179    Mr. O'Neill. Thank you so much for the question, Senator.1180And I really enjoyed our meeting a few weeks ago. I note that1181you mentioned the word mitochondria. I've noticed that 3 years1182ago people didn't know anything about that, they remember from1183high school biology. Oh, yes. Mitochondria, the powerhouse of1184the cell. But in the past few years thanks to a lot of smart1185people talking about metabolism much more than the past, people1186are starting to be interested.11871188    Infectious disease is still a very serious challenge to a1189lot of people. But metabolism metabolic disorders, chronic1190diseases are getting more attention and I think that's1191wonderful. I hope they continue to get attention from1192researchers, from physicians, from patients.11931194    Regarding the food system, the unfortunate situation today1195is that a lot of families really try hard to be healthier and1196have healthier habits and it's not easy. They go to the grocery1197store; junk food is much cheaper than healthy food. They're not1198even sure which food is healthy. Nutrition labels can be1199confusing. Official government nutrition advice, the dietary1200guidelines that two departments issue every 5 years often seem1201to lag by decades. Actual nutrition science, real nutrition1202science is so hard to do, because there's so many stakeholders1203with an interest in particular outcomes.12041205    I think it's essential that we have good nutrition research1206that is free from outside influence. There's a metabolism lab1207at NIH that I visited, where you lock people in a room with1208their consent for days, measure every calorie that goes in and1209goes out, exercise. We need more of that. There was talk a year1210ago of shutting that down, I think we should have more of that.12111212    Senator Marshall. Okay. You also mentioned prioritize1213health for children and I'm going to just focus for a second on1214mental health. I'm not sure if you had the opportunity to read1215the book, the Anxious Generation, but if you haven't, I surely1216would recommend that you do that. What role do you think social1217media apps have played in the mental health of our children and1218young adults?12191220    Mr. O'Neill. Thank you, Senator. That's a great concern.1221So, companies that develop apps have an interest in maximizing1222the amount of time that users spend on the apps. The amount of1223engagement, try to hook them into it, that's expected given1224that they're trying to grow their business. But that's not1225necessarily what's best for users, especially young users.12261227    There's more and more awareness that social media can be an1228addiction, and that it especially could have a profound lasting1229influence on young, developing brains. Brains seem to keep1230developing until age 25. So, people that don't even think of1231themselves as children could still be, well, adults could also1232suffer negatively. So yes, that is a concern that HHS should1233have a role in researching and communicating best practices.12341235    Senator Marshall. Great. Certainly, adds to the loneliness1236as well. Maybe the little time we have left, I just want to1237emphasize the importance of replicating previous studies.1238Again, you mentioned that in your testimony. Over 20 years ago1239in NIH study on Alzheimer's took us down in the wrong1240direction. And that study was never replicated. So, what does1241that look like? I mean, you don't want your best buddy to do1242the replication of that surgery. It needs to be another non-1243biased person. So how do you implement that plan?12441245    Mr. O'Neill. Absolutely. So, there's two ways a study could1246lead us down the wrong road. One is outright fraud, which has1247happened in Alzheimer's research. And the other it's kind of1248bad luck. You do one study, there was no intention of fraud,1249but the results were an unusual combination. The stars were in1250a certain alignment, and it's also not going to replicate. So1251there's a lot of talk about the replication crisis in all of1252science about 10 years ago, and it's still an unsolved problem.12531254    I think NIH should devote--and the problem is no one has a1255financial interest in replicating studies. So, NIH should do1256that. And I think that would be something that NIH can do best,1257whether that should be conducted operationally as one whole1258division of NIH focused on replication, or whether there should1259be a replication branch in each institute. I'm open to1260arguments both ways.12611262    The Chairman. Senator Hassan.12631264    Senator Hassan. Well, thank you, Mr. Chairman and good1265morning, Mr. O'Neill. It's good to see you again. Secretary1266Kennedy has stated that one of his top priorities is to end the1267Fentanyl crisis, which has devastated countless families in New1268Hampshire and as you know and all across the country. One1269critical tool we have when we are fighting fentanyl is an1270overdose reversal medication called Naloxone. Do you agree that1271it is important for first responders to have access to1272Naloxone?12731274    Mr. O'Neill. Thank you. Lovely to see you again, Senator.1275I've very publicly advocated the approval and legalization of1276Naloxone for years. And yes, I believe that you never really1277know when it's going to be needed. When it is needed, you need1278it right there. And yes, I think first responders having it1279makes a lot of sense.12801281    Senator Hassan. President Trump has proposed to eliminate a1282critical program that arms and trains first responders in my1283state and across the country with Naloxone. So, you've just1284made the case for why they need to have it. If confirmed, will1285you use your position to urge Secretary Kennedy and President1286Trump to reverse their cuts to Naloxone funding for first1287responders?12881289    Mr. O'Neill. Senator, there are probably a lot of ways to1290ensure that Naloxone is deployed locally. I'm not really sure1291what the best way to do that is.12921293    Senator Hassan. I can tell you as a former Governor, whose1294state was devastated when the fentanyl crisis first began to1295hit, that it was absolutely critical to have that Federal1296partnership to help fund Naloxone for first responders. State1297budgets can be sparse, and this is a really important tool. So,1298I hope you will urge Secretary Kennedy to reverse that, or at1299least work with states in a transparent way to find out what a1300different way of supporting Naloxone supply is. But just to end1301it without a plan moving forward, I think will really harm1302people and may cost us lives.13031304    Now, I also wanted to turn to another issue that I'm deeply1305concerned about, which is Secretary Kennedy's decision to hire1306David Geier, an individual with a track record of harming1307children. Mr. Geier was disciplined for practicing medicine1308without a license, on children who have autism. And now,1309secretary Kennedy is paying Mr. Geier with taxpayer funds to1310conduct a study at HHS. Mr. O'Neill, if confirmed, would you1311advise the Secretary to fire David Geier?13121313    Mr. O'Neill. Senator, thank you for the question. I've1314never had any communication with this person. I don't know him.1315I would say that all research and research funding decisions1316and analysis research, should involve multiple people, ideally1317with different backgrounds who are allowed to disagree with1318each other.13191320    Senator Hassan. I appreciate that. This is by the way, the1321department's Web site that post Mr. Geier as an employee. Do1322you have concerns about the Secretary employing an individual1323who has been found responsible for harming children?13241325    Mr. O'Neill. Senator, I think that the Secretary is an1326excellent judge of personnel and character. He trusted me and I1327hope to not let him down if confirmed. And I don't know this1328person, so I can't really commit to----13291330    Senator Hassan. Well, what I would like to do is submit by1331unanimous consent for the record, this is the State of1332Maryland's complaint against Mr. Geier for practicing medicine1333without a license on children with autism, including injecting1334an 8-year-old with a testosterone suppressant, as some kind of1335treatment for autism. So, it is really concerning, and I hope1336you will turn your attention to Mr. Geier because----13371338    The Chairman. Was that a request to put it in the record?13391340    Senator Hassan. Yes, it was a request to put in the record.13411342    The Chairman. Without objection.13431344    [The following information can be found on page 27 in1345Additional Material:]13461347    Senator Hassan. Last, I guess I'll just finish up this way.1348I really hope you will look at Mr. Geier's record, look at the1349allegations that were proven in this complaint. He was1350disciplined for practicing medicine without a license on1351children with autism, and it is deeply, deeply concerning. I1352believe he has no place at the country's Premier Health Agency.13531354    Secretary Kennedy also recently made troubling comments1355about children with autism. His comments reflected that he1356understands very little about people who are living with1357disabilities. Instead of taking the time to listen to1358individuals with disabilities and their families, Secretary1359Kennedy has moved to shut down programs and fire staff who1360provide critical support for these families and these1361individuals with disabilities.13621363    For example, Secretary Kennedy fired staff that run the1364National Family Caregiver Support Program, a critical resource1365for people who care for family members with disabilities. Mr.1366O'Neill, will the Secretary's actions to gut caregiver support1367help children with disabilities?13681369    Mr. O'Neill. Senator as you may know, the Secretary has1370made it a priority to research autism. We don't know what1371causes autism. We don't know what causes the recent rise in1372autism. We don't know the best way. We Actually have----13731374    Senator Hassan. Excuse me, I'm running out of time. We1375actually have some really good studies that are leading us to1376understand the multiple causes of autism, but doing away with1377caregiving for these families and these children is not going1378to help them in the way they need. And I hope the Secretary1379will reverse course and listen to families. Thank you, Mr.1380Chairman.13811382    Mr. O'Neill. Thank you, Senator.13831384    The Chairman. We want to take a 2-minute break. We will1385return subject to the call of the Chair.13861387    [Recess.]13881389    The Chairman. The Committee will be back in session, and1390Senator Hawley is next.13911392    Senator Hawley. Thank you very much, Mr. Chairman. Mr.1393O'Neill, nice to see you. I enjoyed our conversation, our visit1394the other day. Let me just start with this. You're familiar, I1395think, with the recent insurance claim study regarding1396Mifepristone. Is that correct?13971398    Mr. O'Neill. Yes, Senator, I've not read the study, but I'm1399familiar with it.14001401    Senator Hawley. This is a study of 865,727 prescribed1402Mifepristone abortions, chemical abortions between 2017 and14032023. It's the largest such study of Mifepristone ever1404conducted. The only major study conducted now in years. And as1405I think the results were really quite startling.14061407    They showed that 10.93 percent of women who use the1408chemical abortion drug experience a major serious adverse1409health event, like sepsis, infection, hemorrhaging, often1410necessitating emergency room visits, often leading to life-1411threatening situations. The dramatic result of this, I mean, I1412think the takeaway of this is that this is a much, much higher1413rate of serious adverse health events than what the FDA1414currently reports, 22 times higher than what the FDA has1415currently reported.14161417    My question is, in light of this new data, and it is truly1418an enormous data set, just an enormous data set, isn't it time1419for the FDA No. 1, to put back in place the reporting1420requirements of serious adverse health events? As you know, in14212016, the FDA eliminated at the behest of the Obama1422administration, eliminated the requirement that physicians and1423others report, non-life threatening, but yet serious health1424adverse health events. Shouldn't we put those back in place in1425light of this data?14261427    Mr. O'Neill. Senator, FDA has a responsibility to ensure1428that all drugs are safe and effective. And sometimes new data1429comes in and it needs a review. Mifepristone actually has a1430REMS, meaning it's been designated for a long time as something1431that needs periodic review of safety data. The Secretary's1432pledged to do a safety review of Mifepristone and I strongly1433support that review.14341435    Senator Hawley. Good. And you'll help him carry out that1436review, that safety review.14371438    Mr. O'Neill. Absolutely.14391440    Senator Hawley. This study that, is out just this last1441week, just underscores the need for ongoing safety review. And1442for a look, I think a fresh look at all the data. Would you1443agree with that?14441445    Mr. O'Neill. It does look that way.14461447    Senator Hawley. Would you also agree that it's time for the1448FDA as part of that thorough top to bottom review, to think1449about reinstating the other longstanding safety protocols on1450this drug?14511452    Until the Biden administration eliminated them,1453Mifepristone for 20-plus years, had always required physician1454dispensing, in-person dispensing, physician follow-up visits,1455the Biden administration eliminated all of those things. Now,1456telehealth providers, you don't even have to be in this country1457now to send this drug, to prescribe it, ``you don't have to be1458a doctor.'' You don't have to see your patient. You don't have1459to be in America. You can mail it into states regardless of1460state law, what state law is, and this is one of the reasons1461we're seeing such incredibly high adverse health events, don't1462you think it's time to reconsider and to revisit imposing,1463putting back in place those longstanding safety protocols?14641465    Mr. O'Neill. Senator, a lot of patients have a lot of1466trouble getting prescriptions filled across state lines, even1467medicines that have much less safety concerns than this drug.1468And of course, every approval that FDA does or reviews can1469state the appropriate and inappropriate ways of prescribing or1470dispensing a drug. And so that all of that should be subject to1471review. Absolutely.14721473    Senator Hawley. Okay, good. All of it is subject to review.1474The Secretary was very clear on this that he will conduct a1475full-scale safety review. He's required to by law, as you1476pointed out. But I think what this latest study shows is that1477the information that is coming into HHS, it's time that you1478take a serious look at the scope of that information, because,1479again, the FDA in 2016 eliminated the requirement to report1480much of this. This is why this study is so significant, because1481it looks at all insurance claims, 865,000 of them between 20171482and 2023.14831484    Just to be clear, your commitment is you will do a safety1485review, you will look at this top to bottom, you will take this1486data into account. Do I have that right?14871488    Mr. O'Neill. I believe the Secretary has already committed1489to that, and I will promise you to fully support that.14901491    Senator Hawley. Good, Okay. Let me ask you about your work1492on conscience protections in an earlier Administration. I think1493in one of the Bush administrations, the Bush 43rd1494administration, you worked on conscience protection rules for1495healthcare providers. Do I have that correct?14961497    Mr. O'Neill. Yes, that's correct. Senator.14981499    Senator Hawley. Would you support reinstating and fully1500implementing conscience protections for healthcare providers?15011502    Mr. O'Neill. That would be up to the Secretary and the1503President. But if they decide to go in that direction, I would1504know exactly how to do it.15051506    Senator Hawley. Would you advise them to do so?15071508    Mr. O'Neill. I believe I already have Senator.15091510    Senator Hawley. Good. And that should be easy because the1511Secretary, when he sat right where you were sitting, said1512unequivocally, that he supported conscience protections, that1513he would put them back into place. The President said he1514supports conscience protections. In fact, the President had1515them in place in his first Administration. So, I'm glad to hear1516that. We'll hold you to that.15171518    Let me talk to you for just a second here. Well, actually,1519I'll write Mr. Chairman, I see that I am out of time, and I'm1520always so good about obeying my time limits, aren't I, Senator1521Kaine?15221523    [Laughter.]15241525    Senator Hawley. I'll have a few--that's a joke. I'll have a1526few more questions for you for the record. Mr. O'Neill, thank1527you, Mr. Chairman.15281529    The Chairman. What's the Definition of prevarication?15301531    [Laughter.]15321533    The Chairman. My Ivy League trained colleague, Senator1534Kaine.15351536    Senator Kaine. Thank you. I appreciate my fellow Rockhurst1537High School alum, Josh Hawley for ceding time to me and not1538going over. There are two high schools in America that have two1539U.S. Senators, James Madison High School in Brooklyn, Bernie1540Sanders and Chuck Schumer and Rockhurst High School in Kansas1541City, Missouri, Josh Hawley, and Tim Kaine. And I think it1542tells us something about the value of a small Catholic1543education that a Josh Hawley and Tim Kaine could both be1544graduates of Rockhurst High School.15451546    The elephant in the room, before I have a question or two1547for you, Mr. O'Neill. I'm concerned and confused that you're1548sitting alone at the table today. This was a hearing that was1549originally noticed to include the surgeon general nominee, the1550circumstances under which she is now not appearing and has had1551a nomination withdrawn is puzzling. I don't know whether it was1552the behest of the Committee, the White House, or some1553combination of both.15541555    But some news accounts suggest that her nomination was1556withdrawn because she positively commented about the COVID1557vaccine, that it was a blessing from God. The COVID vaccine1558development in the first Trump administration was a huge1559accomplishment. Operation Warp Speed. The development of that1560vaccine in such short time relative to other vaccine1561developments at a time when it was critically needed, was a1562real plus in my view.15631564    The thought that because she praised it at the time, that1565would be a reason to withdraw her nomination troubles me. I1566don't know if that was the reason or it was something else, but1567that's being mentioned as a reason for the withdrawal. And that1568will obviously lead to a lot of questions when the new nominee1569is before us.15701571    Mr. O'Neill, you told the Finance Committee the other day1572that you supported focusing Medicaid on the populations it was1573created to support in the 1960's, and I think everyone on the1574Committee believes that. But that opens up a pretty big1575question, which is how about folks who have Medicaid because of1576the Affordable Care Act and Medicaid expansion.15771578    20-plus million Americans, including more than 670,0001579Virginians have Medicaid because of the Medicaid expansion1580component of the Affordable Care Act. As you know, Medicaid1581expansion is a state option. I think 41 of the 50 states have1582embraced Medicaid expansion. Have you made statements in the1583past in opposition to the Affordable Care Act?15841585    Mr. O'Neill. I'm not sure Senator.15861587    Senator Kaine. Can you recall whether you've ever advocated1588in opposition to the Affordable Care Act?15891590    Mr. O'Neill. I don't recall, Senator.15911592    Senator Kaine. Can you recall whether you've ever stated a1593position about the Medicaid expansion part of the Affordable1594Care Act?15951596    Mr. O'Neill. I don't believe I have, Senator.15971598    Senator Kaine. Would you agree with me that if there were a1599proposal to eliminate the Affordable Care Act, including1600Medicaid expansion, that would be a massive and dramatic cut to1601Medicaid?16021603    Mr. O'Neill. I don't know, Senator. I haven't looked at the1604numbers. There was obviously a lot of discussion in President1605Trump's first term about repealing and replacing the Affordable1606Care Act.16071608    Senator Kaine. Repealing, we had a vote on a repeal without1609a replace. And it failed in the Senate because both Republicans1610and Democrats opposed repeal of the Affordable Act without a1611replacement. But you acknowledge that 41 states have embraced1612Medicaid expansion. States that have Republican Governors and1613Democratic Governors, Republican legislatures, and Democratic1614legislatures, you acknowledge that, correct?16151616    Mr. O'Neill. I believe that's accurate. Senator.16171618    Senator Kaine. You would not challenge me when I say more1619than 20 million Americans have health insurance through1620Medicaid expansion. Does that number sound generally in the1621right range to you?16221623    Mr. O'Neill. I believe you, Senator.16241625    Senator Kaine. Have you had conversations either with1626Secretary Kennedy, President Trump, or any other members of the1627Trump administration about repeal of the Affordable Care Act in1628a second Trump Presidential term?16291630    Mr. O'Neill. I don't believe I have, Senator.16311632    Senator Kaine. Have you had conversations with anyone in1633the Trump administration, including Secretary Kennedy, about1634reductions or repeal of the Medicaid expansion part of the1635Affordable Care Act?16361637    Mr. O'Neill. Perhaps very briefly, but I don't recall1638anything in specific.16391640    Senator Kaine. Would it have been full repeal, partial1641repeal, reduction of the subsidies enabling families to afford1642Medicaid expansion? Or do you recall?16431644    Mr. O'Neill. I recall general discussions about preserving1645the core populations of Medicaid and how that's essential, and1646how any changes that Congress might like to make to the1647structure of Medicare would be up to Congress, and it would be1648HHS's responsibility to implement whatever Congress legislates.16491650    Senator Kaine. Well, I want to dispute the notion that1651there is a core recipient of Medicaid and a non-core recipient1652of Medicaid. If you're a struggling family, and the only way1653that you can afford health insurance for your family and kids1654is through Medicaid expansion, that's part of the Affordable1655Care Act. You're not a non-core recipient of Medicaid. Medicaid1656is helping you and your family, and that to me is a core1657responsibility. I yield back, Mr. Chairman.16581659    Mr. O'Neill. Senator, my opening statement, I did point out1660that many families struggle to afford health insurance. That is1661a continuing problem. And that's what I'd like to address, and1662there are probably multiple ways to address it.16631664    The Chairman. For the record, Republicans did have a1665replace plan, I helped co-author it. So, for the record.16661667    Senator Hickenlooper.16681669    Senator Hickenlooper. Thank you, Mr. Chairman. Thank you,1670Mr. O'Neill, for being here. Thank you for your willingness to1671go deeper into public service. You have experience with1672companies that are focused on age related diseases and1673conditions, Alzheimer's being prominent. And certainly, I share1674that interest and been particularly interested in some of the1675research around sugar and ultra processed foods that could be1676connected to dementia, different types of dementia in later1677life.16781679    As you may know, the Trump administration's, NIH funding1680cuts and delays have led to a large amount of confusion, some1681would call it chaos, particularly at the Alzheimer's Disease1682Research Centers. And I mean, let's put it this way, are you1683still interested in further research and understanding into the1684causes of and possible treatments of Alzheimer's and if so,1685will you figure out some way to restore funding to the1686Alzheimer's disease research projects being done at NIH?16871688    Mr. O'Neill. Senator, that does absolutely remain an1689interest. There are multiple causes of dementia, Alzheimer's,1690and Parkinson's, and Lewy bodies are perhaps the three most1691well-known. There could be others. There could be others that1692we don't know about.16931694    I think it's an open scientific question of how much we1695should focus research money more downstream, specifically1696Alzheimer's for these dollars, specifically Parkinson's for1697these dollars, specifically Lewy bodies for these dollars. And1698versus how much we should focus research dollars more upstream1699on what potential common factors and common causes, all kinds1700of dementia and all kinds of aging damage has. I don't have a1701specific answer for that, but it is an area of like1702intellectual and operational interest for me and I would love1703to engage in that.17041705    Senator Hickenlooper. Good. Glad to hear that. In Colorado1706and in a lot of states we worked hard to make access to green1707spaces, a natural outdoor environment, recreational1708opportunity. It was both an economic priority for outdoor1709recreation is a big part of most of the Western states, I'd say1710all the Western states, but also as a public health benefit.1711And making sure that those who work in outdoor spaces are safe,1712I think is a responsibility for all of us and for the Federal1713Government.17141715    Nearly all the workers at the National Institute of1716Occupational Safety and Health have been laid off, equally at1717the same office in Denver. The office in Denver, specifically1718focused on occupational health hazards experienced often1719uniquely in the West, such as wildfire. If you're fighting1720wildfires, what does that particulate and all those noxious1721smoke and fumes that you inhale, what are the consequences of1722that.17231724    If you're confirmed Mr. O'Neill, how will you prioritize1725occupational safety and health, particularly in the West, with1726a severely feeble staff? In other words, the, Federal office1727has been not quite just destroyed, but significantly reduced.17281729    Mr. O'Neill. Thank you, Senator. That is a huge concern. As1730someone who's lived in Marin County, California for the last 141731years, I've had a lot of negative experience with smoke from1732wildfires. I stocked up on N95 masks before the Covid pandemic.1733I recall trying to understand the distinction between the N951734masks that were approved by FDA versus the ones that were1735approved by NIOSH. They seem very similar. I think they are1736pretty similar. Of course, it's important that all parts of1737government, including state governments, do their best to1738prevent wildfires and respond to them and HHS, of course, has a1739role.17401741    Senator Hickenlooper. I'm fine with that. And I guess my1742question is really, are you going to fight like hell to make1743sure you get enough funding so you can do some of that basic1744research because it is ongoing and critical.17451746    Last question, and then I'll let you go. As you know, the1747National Institutes of Health are the largest funders of1748biomedical research on earth. Basic research often informs the1749next big discovery, often done in-house at NIH. Many biomedical1750companies are not incentivized to do this nuts-and-bolts1751research that translates into the big deal. And yet we all1752depend on that research.17531754    If confirmed as Deputy Secretary, how are you going to1755incentivize private companies and institutions to conduct1756research that historically they have depended on NIH for, but1757now they are going to have to do on their own?17581759    Mr. O'Neill. I think I agree with the whole premise of your1760question very strongly, Senator. Companies have a financial1761incentive to do late-stage translational research. They don't1762have an incentive to do basic research, which is also harder to1763patent. It's important that NIH do very extensive basic1764research because almost no one else will.17651766    Senator Hickenlooper. You're going to have a lot of work to1767do. Thank you very much.17681769    Mr. O'Neill. Thank you, Senator.17701771    Senator Hickenlooper. I yield.17721773    The Chairman. Mr. O'Neill just a follow-up. In my question,1774I asked regarding, there's a current effective mandate of CDC,1775if somebody wishes to become a permanent resident of the United1776States legally, it is effectively mandated that they receive1777vaccines. Would knowing your opposition to mandates, would you1778attempt to rescind that?17791780    Mr. O'Neill. Senator, I share a concern about either legal1781immigrants or illegal immigrants coming into the country with1782an infectious disease or without recommended vaccinations. I've1783not had a chance to discuss. I've been focused on most of the1784vaccine questions on rules for citizens and advice to citizens.1785I haven't had a chance to discuss rules for legal immigrants1786with the Secretary. But I would be happy if confirmed to dig in1787on that issue.17881789    The Chairman. Well, I will have that as my question for the1790record, if you could respond to that before next week. And for1791any other senator wishing to ask additional questions,1792questions for the record will be due at 5 p.m. tomorrow, May17939th. Thank you, again, to Mr. O'Neill for being here.17941795    The Committee stands adjourned.17961797                          ADDITIONAL MATERIAL17981799[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]18001801                        QUESTIONS FOR THE RECORD18021803       Responses by James O'Neill to Questions of Senator Cassidy1804                            senator cassidy1805                          Vaccine Requirements18061807    Question 1. Currently, refugees resettling to the U.S. are not1808statutorily required to be vaccinated. However, CDC ``strongly1809recommend[s]'' that refugees receive routine vaccinations before travel1810to the U.S. ``to protect health, prevent morbidity and travel delays1811due to disease outbreaks, and to facilitate earlier school enrollment1812for children after arrival.''18131814    Do you support requiring refugees, prior to their arrival in the1815U.S., to receive the same vaccines against vaccine-preventable diseases1816that are statutorily required for aliens lawfully seeking admission as1817an immigrant or seeking adjustment of immigration status to become a1818lawful permanent resident under Section 212(a)(1)(A)(ii) of the1819Immigration and Nationality Act? Alternatively, do you support1820requiring refugees to receive these vaccines within 1 year of their1821arrival to the U.S. to continue to maintain their lawful refugee1822status?18231824    Question 2. Currently, illegal aliens are not required to be1825vaccinated even if they are detained by immigration enforcement1826authorities. Therefore, unvaccinated illegal aliens who are released1827from detention into the U.S. are at risk of spreading infectious1828diseases.18291830    Do you support requiring illegal aliens detained and in the custody1831of Immigration and Customs Enforcement or Customs and Border Protection1832to receive the same vaccines against vaccine-preventable diseases1833outlined in question 1 prior to their release from detention?18341835    Answer 1-2. I support and will follow the law. I share your desire1836to ensure illegal immigrants are not bringing diseases into our country1837and, if confirmed, will evaluate applicable HHS policies and legal1838authorities. President Trump explicitly acknowledged this threat in his1839January 20, 2025 Executive Order entitled ``Guaranteeing the States1840Protection Against Invasion, and I commit to working with you and the1841Department of Homeland Security to ensure that aliens--whether legal or1842illegal--in no way threaten the health of the American people.1843                                 ______18441845       Responses by James O'Neill to Questions of Senator Hawley1846                             senator hawley1847    Question 1. In his first term, President Trump issued his ``most1848favored Nation'' prescription drug pricing rule to prevent Medicare1849from paying prices multiple times higher than what other countries pay.1850He is reportedly planning to revive this policy.18511852        (a). If confirmed, will you fully implement the President's1853        drug pricing agenda, including his ``most favored Nation''1854        policy?18551856        (b). If confirmed, will you commit to using every tool at your1857        disposal to deliver the best drug prices possible for1858        Americans?18591860    Answer 1(a)-(b). The President has committed to lowering the price1861of drugs for all Americans. If confirmed, I look forward to working1862with you to ensure that all the dollars in the American healthcare1863system are devoted to working for the patient--including lowering the1864price of drugs by ensuring transparency in costs, providing1865accountability to middlemen, looking for innovative ways to provide1866high-cost drugs at low prices, and making sure other countries pay1867their fair share for prescription drugs.18681869    Question 2. Do you support restoring the first Trump1870administration's Title X rule--known as the Protect Life rule--which1871bars Title X dollars from going to organizations like Planned1872Parenthood that promote abortion?18731874    Answer 2. I would fully implement President Trump's agenda on the1875issue of life. That includes President Trump's Executive Order on1876Enforcing the Hyde Amendment to stop taxpayer dollars from funding or1877promoting abortion. If confirmed, I will also carry out the Protecting1878Life in Global Health Assistance policy and work to strengthen1879enforcement of Federal conscience laws.18801881    Question 3. If confirmed, how do you plan to use your position to1882limit consolidation in the healthcare industry, which often harms rural1883providers?18841885    Answer 3. If confirmed, I look forward to working with Congress and1886the FTC to evaluate and address market consolidation issues and ensure1887high quality care and good prices for American patients.1888                                 ______18891890    [Whereupon, at 11:22 a.m., the hearing was adjourned.]18911892                                 [all]