[Senate Hearing 119-89]
[From the U.S. Government Publishing Office]
S. Hrg. 119-89
NOMINATION OF JAMES O'NEILL
TO SERVE AS DEPUTY SECRETARY
OF HEALTH AND HUMAN SERVICES
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED NINETEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE NOMINATION OF JAMES O'NEILL, OF CALIFORNIA, TO BE DEPUTY
SECRETARY OF HEALTH AND HUMAN SERVICES
__________
MAY 8, 2025
__________
Printed for the use of the Committee on Health, Education, Labor, and Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
60-599 PDF WASHINGTON : 2026
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
BILL CASSIDY, M.D., Louisiana, Chairman
RAND PAUL, M.D., Kentucky BERNIE SANDERS (I), Vermont,
SUSAN M. COLLINS, Maine Ranking Member
LISA MURKOWSKI, Alaska PATTY MURRAY, Washington
MARKWAYNE MULLIN, Oklahoma TAMMY BALDWIN, Wisconsin
ROGER MARSHALL, M.D., Kansas CHRISTOPHER MURPHY, Connecticut
TIM SCOTT, South Carolina TIM KAINE, Virginia
JOSH HAWLEY, Missouri MAGGIE HASSAN, New Hampshire
TOMMY TUBERVILLE, Alabama JOHN HICKENLOOPER, Colorado
JIM BANKS, Indiana ED MARKEY, Massachusetts
JON HUSTED, Ohio ANDY KIM, New Jersey
ASHLEY MOODY, Florida LISA BLUNT ROCHESTER, Delaware
ANGELA ALSOBROOKS, Maryland
Matthew Gallivan, Majority Staff Director
Danielle Janowski, Majority Deputy Staff Director
Warren Gunnels, Minority Staff Director
Zain Rizvi, Minority Deputy Staff Director
C O N T E N T S
----------
STATEMENTS
THURSDAY, MAY 8, 2025
Page
Committee Members
Cassidy, Hon. Bill, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Baldwin, Hon. Tammy, U.S. Senator from the State of Wisconsin,
statement...................................................... 2
Alsobrooks, Hon. Angela, U.S. Senator from the State of Maryland,
Opening statement.............................................. 2
Thompson, Hon. Tommy G., Former Governor of the State of
Wisconsin, statement........................................... 4
Witnesses
O'Neill, James, Tiburon, CA...................................... 4
Prepared statement........................................... 6
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Hassan, Hon. Maggie
State of Maryland's complaint against Mr. Geier.............. 27
QUESTIONS FOR THE RECORD
Response by James O'Neill to questions of:
Senator Cassidy.............................................. 82
Senator Hawley............................................... 82
NOMINATION OF JAMES O'NEILL
TO SERVE AS DEPUTY SECRETARY
OF HEALTH AND HUMAN SERVICES
----------
Thursday, May 8, 2025
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:02 a.m., in
room SD-430, Dirksen Senate Office Building, Hon. Bill Cassidy,
presiding.
Present: Senators Cassidy [presiding], Marshall, Hawley,
Husted, Moody, Alsobrooks, Murray, Baldwin, Kaine, Hassan, and
Hickenlooper.
OPENING STATEMENT OF SENATOR CASSIDY
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will come to order. This morning, we're
having a hearing on the nomination of Mr. James O'Neill to
serve as the Deputy Secretary of Health and Human Services.
Actually, Senator Alsobrook, is substituting for Ranking
Member Sanders, she and I will both have opening statements.
Then former Wisconsin Governor and HHS Secretary Tommy
Thompson, will introduce our witness, although I think we're
going to have Senator Baldwin introduce Governor Thompson. Then
Mr. O'Neill will have 5 minutes for his opening statements and
Senators will then each have 5 minutes for questions.
Thank you, Mr. O'Neill, for being here and for your
willingness to serve. The Nation faces enormous health threats,
including rising healthcare costs, mental health and substance
use disorder crisis, a breakdown in public trust in healthcare
institutions, two high levels of chronic disease, and a
preventable measles outbreak, which has taken three lives and
hospitalized many others.
I will note that from 2000 to 2024, the United States saw a
total of three measles death. Now we've had three measles
deaths in just 4 months of this current outbreak. We should be
incredibly troubled.
The American people want solutions to make their lives
easier. They want results and not excuses. President Trump
working with Secretary of Health and Human Services, Kennedy,
has laid out a bold vision to make healthcare more affordable
and to make America healthy again. To do this, he needs
officials with the expertise and vision to carry out his agenda
while also increasing transparency, restoring trust, and
ensuring that science, not politics, drives decision-making.
This is why this nomination is so important.
If confirmed as Deputy HHS Secretary, Mr. O'Neill will be
responsible for implementing the President's agenda at HHS,
under Secretary Kennedy's leadership. He will help steer a ship
going through massive changes. The Deputy Secretary needs to be
someone whom Americans can trust to make science-based
decisions to strengthen HHS and to make America healthier.
I look forward to hearing your plans and vision to
accomplish this. Thank you for coming before this Committee and
being willing to serve. I look forward to discussing how we can
fulfill the vision of making America healthy again.
Senator Alsobrooks is not here, so walking in right now--
I'm looking out there and I don't see him walking in right now.
So, would you like to introduce the Hon. Governor?
Senator Baldwin. I'd be honored.
The Chairman. Please.
STATEMENT OF SENATOR TAMMY BALDWIN
Senator Baldwin. We have here today to introduce our
witness, Governor Tommy G. Thompson, the longest serving
Wisconsin Governor and one who prioritized the issues that this
Committee focuses on: health, education, labor, and pensions.
Not only did he serve his country as the Secretary of
Health and Human Services, and I remember fondly a dinner we
had together with Diana DeGette when I was in the house to
focus on biomedical research. But following that incredible
tenure of service, Tommy G. Thompson filled in as President of
our University of Wisconsin system, during a time of great
challenge, the pandemic, and was a champion once again of our
university system.
I'm just delighted to have you here. And would defer back
to the Chairman of the Committee to introduce our Ranking
Member for her opening statement.
The Chairman. Senator Alsobrooks.
OPENING STATEMENT OF SENATOR ANGELA ALSOBROOKS
Senator Alsobrooks. Thank you so much, Chairman Cassidy.
And for those who are wondering, I am not Bernie Sanders. I am
Angela Alsobrooks. Ranking Member Sanders is unable to be here
this morning, but I'd like to say a few words on behalf of the
Minority.
Today we are considering President Trump's nominee to be
the Deputy Secretary of Health and Human Services, Jim O'Neill.
We were also going to consider the President's nominee to be
the next Surgeon General of the United States, Dr. Janette
Nesheiwat, a Fox News medical contributor, and a graduate of
medical school, but for whatever reason, President Trump
abruptly withdrew her nomination yesterday afternoon.
As we all know; this is the second time that President
Trump has withdrawn a nominee within our Committee's
jurisdiction. In March, he withdrew the nomination of Dave
Weldon, who spent years lying about the safety and efficacy of
vaccines to head the CDC about an hour before his hearing was
set to begin.
At any rate, Mr. O'Neill, thank you so much, sir, for being
here today. And Mr. Chairman, I'd like to say that in America
today, we have a healthcare system that is broken, outrageously
expensive, and horrifically cruel. We also spend twice as much
per capita on healthcare as any other country on earth, over
$14,500 per year. And despite these huge expenditures, we
remain the only major country on earth not to guarantee
healthcare to all people as a human right.
Over 85 million Americans are still either uninsured or
underinsured. The result: over 60,000 people in our Country die
each year because they cannot afford to go to a doctor when
they should. More than half a million Americans go bankrupt due
to medically related debt, and one out of four Americans cannot
afford to buy the medicine their doctors prescribe.
Sadly, as dysfunctional as our current healthcare system in
America is, this Administration and many of my Republican
colleagues are actively working to make it worse. As we speak,
Republicans in Congress are writing a ``Reconciliation bill''
that would decimate Medicaid and throw millions of Americans
off the healthcare that they have in order to give huge tax
breaks to the wealthiest people and most profitable
corporations in America.
Let's be clear, when some of our Republican colleagues talk
about cutting Medicaid by up to $880 billion dollars, they are
talking about making devastating cuts to community health
centers, which rely on Medicaid for 43 percent of their
revenue, mostly children, and provide primary healthcare to 32
million people. They're also talking about cutting funding for
nursing homes, which depend on Medicaid for some two thirds of
their revenue.
Further, since the President has been in office, 20,000
employees at the Department of Health and Human Services have
been terminated or forced out, threatening the healthcare and
well-being of millions of Americans who rely on Head Start, the
Older Americans Act, Medicare, Medicaid, and LIHEAP.
My home State of Maryland has been reeling from these cuts.
Not only do we have over 150,000 dedicated Federal civil
servants in Maryland, but we are home to Federal health
agencies like NIH, FDA, SAMHSA, CMS, the Health Resources and
Services Administration, and AHRQ.
We need a Deputy Secretary of Health and Human Services who
will speak out against these devastating cuts and strongly
oppose decimating Medicaid. All of us want to make the
government more efficient, but we don't do this by slashing the
agency in charge of the health and well-being of tens of
millions of seniors, children, people with disabilities,
working families, and the most vulnerable people in our
Country.
We need a Deputy Secretary of Health and Human Services who
will fight, to continue healthcare as a human right, not as a
privilege, regardless of whether you are poor, working class or
wealthy.
Mr. O'Neill I have carefully reviewed your record and
background, and unfortunately, it is very clear to me that you,
sir, are not that person. And I'm concerned that you will be
just another rubber stamp for Donald Trump's rapid movement
toward the destabilization of our healthcare system. Thank you,
Mr. Chairman.
The Chairman. Thank you, Senator Alsobrooks. And now I
recognize Governor Thompson to introduce our nominee.
STATEMENT OF HON. TOMMY G. THOMPSON, FORMER GOVERNOR OF THE
STATE OF WISCONSIN
Honorable Thompson. Senator Cassidy, thank you very much
for allowing me to speak shortly and quickly about an
outstanding individual, my friend Jim O'Neill. I would like to
quickly add, that thank you for the very kind words from
Senator Baldwin, and I appreciate it very much. The good
Senator and I go back a long time with different political
parties, but we're still very close friends, and I thank you
very much for your very kind words. Appreciate it.
To all the distinguished Senators, thank you for giving me
this opportunity. Members of the HELP Committee, it's my
pleasure to introduce Jim O'Neill, President Trump's nominee to
be Deputy Secretary of the United States Department of the
Health and Human Services. I had the privilege of having Jim
work with me and for me when I was secretary of HHS. And based
on my experience, I can tell you that he's an excellent choice
to help manage this department.
He is a hard worker, a good listener, a brilliant thinker
and at HHS, he took the time to really learn the department,
and he gained a deep understanding of how HHS works. I can also
tell you that Jim is a compassionate person who cares deeply
about the mission of HHS. He's an evidence-based decision-
maker, and he cares and believes in good science.
Since his time in government, Jim has become an
entrepreneurial leader and a manager of complex businesses. He
has worked with and learned from some of the best and brightest
minds in business and in technology. He has a deep respect for
innovation and new ideas. He likes to make things work.
As the distinguished Members of this Committee know all too
well, our health system is broken, costs are too high, and
people are too sick. We need a health system that produces
better results for patients. And with all of these challenges
in mind, and Jim's highly relevant experience, I can tell you
and testify with great certainty that Jim O'Neill is an
outstanding choice for Deputy Secretary of HHS and will do the
job well, and you will all be proud of his effort.
Thank you very much, all of you.
The Chairman. Mr. O'Neill, you are recognized for your
statement.
STATEMENT OF JAMES O'NEILL, TIBURON, CA
Mr. O'Neill. Thank you so much, Governor. You've always
been a wonderful mentor and role model, and if confirmed, I
hope to live up to your record.
Good morning. Chairman Cassidy, Senator Alsobrooks,
distinguished Members of this Committee: thank you so much for
inviting me to talk with you today.
Imagine every American waking up, vibrant, energetic, and
free of disease. That's President Trump's vision to make
America healthy again. And I'm honored to be nominated to help
turn it into reality. I'm grateful to Secretary Kennedy for his
bold leadership and for his trust in my experience to deliver
results. My children, Eve, Sebastian, and Cecily, are in school
in California today, but they're why I'm here: I want them and
every child to inherit a healthier nation.
Mr. Chairman, I believe that all Americans deserve to be
healthy, happy, and prosperous. Most families try to make
healthy choices, but our food system pushes ultra processed
foods. Our official nutrition advice creates confusion. Our
healthcare system is difficult to navigate, and it prioritizes
pills over prevention.
Providers spend too much time clicking through pop-up
screens and fighting with insurance companies, instead of
looking patients in the eye. Federal policies can empower
people to break this cycle. If confirmed, I'll help reform
outdated rules, pursue transparency in gold standard science,
and champion healthy lifestyles and prevention so Americans can
thrive.
For three decades, I've worked to improve healthcare. As a
Senate staffer in the 1990's, I helped Senators shape
bipartisan reforms, including HIPAA-collaborating with
lawmakers to protect patient privacy.
During the Bush administration, I had the pleasure of
working at HHS for 6 years with Secretary Thompson, Secretary
Mike Leavitt, and thousands of talented career and appointed
colleagues. I'm proud of my work there, and I learned a great
deal about the responsibility structures and dedicated
professionals of each of the operating divisions of the
department, and how those divisions can best serve the American
people and improve their health and welfare.
At HHS, I helped Congress pass the Medicare Modernization
Act, modernize FDA, and strengthen food safety. I improved
preparedness for avian influenza and hurricanes by helping
establish the Administration for Strategic Preparedness and
Response after it was authorized by Congress. I conducted
health diplomacy, by visiting allied countries and working with
ministers of health. I served on the President's Management
Council and led HHS to earn the highest possible management
score.
Most recently in California, I've partnered with
entrepreneurs to advance cutting edge research, technologies,
and therapies. And this experience has reinforced my conviction
that government must support, not hinder innovators to deliver
effective and affordable results that get better every year.
I've seen what happens when you pair the brightest minds with
the best tools and data, and we must bring that same dynamism
into government.
Sadly, America's health is in crisis. Three quarters of
Americans are overweight or obese, leading to chronic diseases
like diabetes, high blood pressure, and over time heart attacks
and kidney failure. Diabetes alone costs us $400 billion every
year, and has exploded in prevalence tenfold since 1960.
Fentanyl ravages our cities and our countryside. Addiction
and mental health are urgent unsolved problems. Since 2000,
suicide has increased by 37 percent. Medicare hospital
insurance is headed toward insolvency. Families struggle to
afford individual insurance. We spend $4.7 trillion on
healthcare-double the OECD average, yet our life expectancy is
actually shorter than it was in 2010. These aren't just
numbers. There are a call to action. Overall, what we're doing
is just not working.
That's why I'm so grateful to President Trump and Secretary
Kennedy for taking on these challenges and promoting a vision
for change. Mr. Chairman, we have a century scale opportunity
to act. If confirmed, I'm eager to rejoin HHS and: reform our
food system to prioritize health for our children and parents,
pursue gold standard basic and translational research that
replicates, use science, economics, and artificial intelligence
to improve the quality and affordability of healthcare, and
accelerate development and access to lifesaving and health
extending treatments.
I'm ready to work with this Committee, to make a
generational change in our Nation's health. For my children,
for our families, and for every American, I pledge to fight for
a future where everyone can enjoy a long, vigorous, and
prosperous life. I look forward to your questions.
[The prepared statement of Mr. O'Neill follows.]
prepared statement of james o'neill
Good morning. Chairman Cassidy, Ranking Member Sanders, and
distinguished Members of this Committee: thank you for inviting me to
appear before you today.
Imagine every American waking up vibrant, energetic, and free of
disease. That's President Trump's vision to make America healthy again,
and I'm honored to be nominated to help turn it into reality.
I'm grateful to Secretary Kennedy for his bold leadership and for
his trust in my experience to deliver results.
My children Eve, Sebastian, and Cecily are in school in California
today, but they're why I'm here: I want them, and every child, to
inherit a healthier nation.
Mr. Chairman, I believe that all Americans deserve to be healthy,
happy, and prosperous. Most families try to make healthy choices, but
our food system pushes ultra-processed foods, our official nutrition
advice creates confusion, our health care system is difficult to
navigate and it prioritizes pills over prevention. Providers spend too
much time clicking through popup screens and fighting with insurance
companies instead of looking patients in the eye. Federal policies can
empower people to break this cycle. If confirmed, I'll help reform
outdated rules, pursue transparency and gold standard science, and
champion healthy lifestyles and prevention so Americans can thrive.
For three decades, I've worked to improve health care. As a Senate
staffer in the 1990's, I helped Senators shape bipartisan reforms
including HIPAA--collaborating with lawmakers to protect patient
privacy.
During the Bush administration, I had the pleasure of working at
HHS for 6 years with Secretary Tommy Thompson, Secretary Mike Leavitt,
and thousands of talented career and appointed colleagues. I am proud
of my work there, and I learned a great deal about the
responsibilities, structures, and dedicated professionals of each of
the operating divisions of the Department, and how those divisions can
best serve the American people and improve their health and welfare.
At HHS, I helped pass the Medicare Modernization Act, modernize the
FDA, and strengthen food safety. I improved preparedness for avian
influenza and hurricanes by helping establish the Administration for
Strategic Preparedness and Response after it was authorized by
Congress. I conducted health diplomacy by visiting allied countries and
working with ministers of health. I served on the President's
Management Council and led HHS to earn the highest possible management
score.
Most recently, in California, I've partnered with entrepreneurs to
advance cutting-edge research, technologies, and therapies, and this
experience has reinforced my conviction that government must support,
not hinder, innovators to deliver effective and affordable results that
get better every year. I've seen what happens when you pair the
brightest minds with the best tools and data, and we must bring that
same dynamism into government.
Sadly, America's health is in crisis. Three quarters of Americans
are overweight or obese, leading to chronic diseases like diabetes,
high blood pressure, and over time, heart attacks and kidney failure.
Diabetes alone costs us $400 billion every year, and it has exploded in
prevalence tenfold since 1960. Fentanyl ravages our cities and our
countryside. Addiction and mental health are urgent unsolved problems.
Since 2000, suicide has increased by 37 percent. Medicare hospital
insurance is headed toward insolvency. Families struggle to afford
individual insurance. We spend $4.1 trillion on health care--double the
OECD average--yet our life expectancy is actually shorter than it was
in 2010. These aren't just numbers; they're a call to action. Overall,
what we've been doing is just not working.
That's why I am so grateful to President Trump and Secretary
Kennedy for taking on these challenges and promoting a vision for
change.
Mr. Chairman, we have a century-scale opportunity to act. If
confirmed, I'm eager to rejoin HHS and:
reform our food system to prioritize health for our
children and parents;
pursue gold-standard basic and translational research
that replicates;
use science, economics, and artificial intelligence
to improve the quality and affordability of health care; and
accelerate development and access to life-saving and
health-extending treatments.
I'm ready to work with this Committee to make a generational change
in our Nation's health.
For my children, for our families, and for every American, I pledge
to fight for a future where everyone can enjoy a long, vigorous, and
prosperous life.
I look forward to your questions.
______
The Chairman. Thank you, sir. I'll start. You worked on
HIPAA in your previous work. I think HIPAA needs to be updated.
AI, I think has the ability to exploit. Can you have any
thoughts on that or how would you potentially work with us--
what are your thoughts along those lines, please?
Mr. O'Neill. Yes. Thank you. So, I was at HHS during the
promulgation of the HIPAA privacy rule, which was led by the
Office of Civil Rights. I was not at the center of that
discussion, but I was on the periphery. I definitely strongly
support the principle of medical privacy. Patients' private
health data needs to remain private, needs to only be shared
with people that they consent to be sharing to.
AI, as I said, has tremendous potential to improve
healthcare across the board and improve the functions of the
department. But yes, of course, we need to periodically review
the HIPAA privacy rule and make sure that it is not leaving
patient data open to threats because of AI.
The Chairman. It does seem like AI could do a lot of
things, for example, my search history or my watch. Because
I've had legislation regarding that-bipartisan, which would be
very impactful upon somebody deciding whether to hire me.
Should we have a broader definition of what is protected health
information?
Mr. O'Neill. That seems like a reasonable thing to consider
as we look at the privacy rule. I'm not sure the privacy rule--
Well, you might know more than I do, I don't think employers
have any current legal access to health records.
The Chairman. Not only health records, but I was told once
by someone who is a headhunter that he can somehow access
people's search history. And if someone is looking for in vitro
fertilization, for example, would tell the potential employer,
oh, this person's investigating IVF, she may be--you see where
I'm going with that.
Mr. O'Neill. That does sound like a significant concern.
And if confirmed, I'd be happy to make sure that the HIPAA
privacy rule is up to date with regard to AI and, and whatever
is necessary, both legally and technologically, to ensure that
patient's data is not shared anywhere without their consent, as
well as search history and other related things.
The Chairman. You and I have discussed immunization
mandates, and you've mentioned that you--am I correctly
characterizing your view, you support immunization, but you
don't think the Federal Government should mandate rather, that
decision should be held to localities?
Mr. O'Neill. Yes. Senator.
The Chairman. Right now, for someone who wishes to become a
permanent resident in the United States, it is mandated that
they be up to date on CDC recommended vaccines. Frankly, we
don't mandate for that, for those people who come across the
border illegally, and are then transmitted into the interior of
the country. And I've gathered that a lot of the measles that
we're seeing right now, for example, in my state in New
Orleans, is coming from people coming to our Country from
elsewhere and bringing measles with them.
First, do you agree that the Federal Government should
mandate that if someone becomes a U.S. citizen, that they'd be
up to date on their immunizations?
Mr. O'Neill. Senator, as you know, I'm very strongly
practicing pro-vaccine. I'm an advisor to a vaccine company. I
support the CDC vaccine schedule. I mean, I think by
definition, illegal immigrants are not passing through any kind
of checkpoint that could check for their vaccine.
The Chairman. But when they're arrested, if you will,
detained, they're brought to an area which HHS has a role in,
and they receive medical services, screened for tuberculosis,
that sort of thing, and then passed through. So, there is a
role that HHS has in making sure that these folks are safe. And
yet we see measles being introduced in our Country by people
who are from outside our Country.
First, would you accept a mandate? Do you agree with the
mandate which currently exists, that if somebody wishes to
become a legal resident, that they'd be up to date on their
immunizations as per recommended by CDC?
Mr. O'Neill. I haven't looked into the immigration law
aspect of this, but I do support the CDC schedule and that rule
seems reasonable.
The Chairman. This is about the mandate?
Mr. O'Neill. Yes, I understand. I said that rule seems
reasonable to me.
The Chairman. Then what about those who are coming? Because
frankly, since we have measles coming to our Country, from
people from outside, it seems relevant to me. I would like to
say, wait a second. If you're coming to our Country, we don't
expect you to bring disease, and we expect you therefore to be
up to date on your immunizations.
Does your opposition to mandates on a Federal level, would
it extend to that sort of--would you oppose that sort of
mandate? Because if you come here legally, you got to get it
right. The crazy thing is if you come here illegally, you don't
have to get it, which just doesn't make sense to me.
Mr. O'Neill. Senator, I think President Trump's been very
successful at controlling the border at significantly----
The Chairman. Yes. But there'll be a future President.
Mr. O'Neill. Sure.
The Chairman. We're establishing law now for future
Presidents, not just our own.
Mr. O'Neill. Well, I think future Presidents could not only
change border enforcement, they could also change the rules for
naturalization and for what kind of medical requirements are
put on legal and Illegal records.
The Chairman. I'll come back to that maybe at the very end.
Mr. O'Neill. Okay. Sure. Thank You, Senator.
The Chairman. Senator Alsobrooks----
Senator Murray.
Senator Murray. Thank you very much, and thank you for the
accommodation. And Mr. Chairman, I just want you to know, the
Trump administration fired many of the CDC Port Health Station
staff. In fact, at SeaTac in my state, there used to be four.
They are the persons that screen travelers at the ports of any
entry. So, if we don't have people there to screen, even a
mandate would make it very difficult to assure that. So, I
share your concern, but I also think we have to have personnel
there to do it.
With that, Mr. O'Neill we know right now that at HHS,
they're undertaking a massive reorganization, firing staff,
canceling, and terminating thousands of grants and contracts
worth billions of dollars, delaying sending that grant funding
out, including, by the way, for lifesaving biomedical research.
Meanwhile, HHS is currently, and I know you're not there
yet, but they're refusing to provide basic answers to many of
our straightforward questions. They're canceling longstanding
briefings, and they're telling Congress and virtually the
American public nothing about these dramatic, unprecedented
changes.
Last week, HHS submitted an operating plan for fiscal year
25 required by law, and it leaves it blank. The funding levels
for 530 programs were left blank. The department is effectively
telling us, it doesn't have to tell us or the American people
anything, about how it is going to spend tens of billions of
dollars, taxpayer dollars across hundreds of programs. And that
is really stunning to me.
In my time in Congress, I have never seen an Administration
less transparent than this one. I've also never seen an
Administration so insistent on pretending they are transparent
while going out of their way to hide basic information that we
require.
Mr. O'Neill. I want to ask you, if you are confirmed, will
you commit to prioritizing real transparency and sharing
information with Congress and the American public about what
HHS is doing?
Mr. O'Neill. Thank you for the questions, Senator. It's
lovely to see you. I was a Senate staffer in the 1990's. We had
a few pleasant interactions. I don't expect you to remember.
But yes, I have a kind of visceral sense that it's Congress
that authorizes all the programs at HHS, it's Congress that
appropriates the money for HHS. Congress absolutely deserves to
have prompt and accurate information, both proactively about
future plans and also in reply to questions, whether it's
testimony or written questions.
Yes, I commit if confirmed to ensure that the whole
department takes seriously its obligation to provide good,
transparent, accurate, prompt information to Congress.
Senator Murray. Well, I appreciate that answer. I'm not
holding my breath because I haven't seen it happen yet. But Mr.
Chairman, I want you to know I am focused on real transparency
here. This department is not above Congressional oversight. And
we have a responsibility and a need to hold all the agencies
accountable. So, this is something I'm tracking very closely.
I wanted to ask you quickly too about women's health. The
plan to gut HHS is a disaster for health and safety, but it is
based, it seems to me, on a total lack of understanding about
how different agencies across the department work. For example,
Senator Kennedy, seems to think we shouldn't have more than one
office that covers women's health. Well, women's health
requires dedicated focus in different areas, for example;
workforce training at HRSA, cancer prevention at CDC,
scientific research at NIH. Those are separate and distinct
efforts addressing women's health, which has long been
underfunded. But because of Congress's dedicated bipartisan
investments, we've been able to make progress.
If you are confirmed, will you commit to restoring women's
health functions across HHS, and directing the department to
spend appropriated funds for women's health as directed by
Congress?
Mr. O'Neill. Thank you for the question, Senator.
Obviously, women's health will continue to be a critical issue.
It is distinct from Men's health in many significant ways.
The principles of the secretary outlined for the proposed
reorg, said that any reorg would be based on preserving all the
central functions of the department, ensuring that they
continue and that they're executed on well as mandated by
statute, and also the principle that two functions make more
sense to be conducted within the same agency or office, that
could make sense. It also makes sense to me that if functions
are closely similar, perhaps we should consider putting them in
the same office.
Senator Murray. Well, I would just say, Mr. Chairman,
women's health isn't just one little corner. We are affected--
women are affected in many different ways, including, as I
said, through workforce training, through cancer prevention,
through scientific research, different agencies. Those offices
all do very different things. There's a reason why Congress
passed funding for each one of them. Ignoring that means
ignoring the law. Thank you, Mr. Chairman.
The Chairman. Senator Moody.
Senator Moody. Thank you, sir. Thank you for being here.
And if I might just say thank you to your family. Senator
Houston and I are the two newest Members of the U.S. Senate,
and our families are also serving. It is certainly a family
sacrifice, and I'm so grateful you're willing to come back in
to public service using all that you have acquired both in your
government service and your private experience to benefit
Americans and their health. So, thank you very much.
As Deputy Secretary, you will oversee the operations of the
department, from the FDA to Office of Refugee Resettlement,
including many actions related to the regulatory side of the
department. I wanted to talk to you about some issues certainly
as a mother and as the former Attorney General of Florida that
I saw not handled well at all in, in fact, it was a disaster
under the Biden administration.
I wanted to get your take on how you might approach making
sure that it can never happen again, and any regulations or
oversight is considered and modified within the agency to make
sure it never happens again.
Specifically, we saw that when Biden opened up the border
and destroyed any semblance of security, we saw many, many
young minor children smuggled into our Country, pushed into
states throughout. The office of Refugee Resettlement was
supposed to oversee this. It got so bad that they lost tens of
thousands of children.
In Florida, we could get no information from the Biden
administration on who these children were, where they were
being placed, how they were being taken care of. Even though
the states have a primary responsibility of dealing with
neglected, abandoned, abused children, no information was
shared.
In order to remedy that, we went so far as to launch a
grand jury investigation. And when we asked for Administration
officials to come down and testify or share information, they
refused to do so, they said that it was hard to see how it
would benefit the agency. When all we cared about was the
interest of those children who not only were smuggled into the
United States. Our grand jury report showed that they had been,
some had been sent to strip clubs, empty lots next to container
facilities, dozens placed with the same sponsor, many unvetted,
it was inviting trafficking. In fact, many children in the
United States were found to have been in trafficking that had
been smuggled over the border.
I believe and I believe the Grand Jury report shows that
this obfuscation, or refusal to provide information or
witnesses was to shield the fact they knew these kids were not
being supervised, being put in dangerous situations, and they
were, in fact, the Administration, in fact, was facilitating
trafficking.
What will you do, knowing that the Office of Refugee
Resettlement is going to be in terms of operations, is going to
be under your purview? What will you do to ensure--Now again,
we know that in the first 100 days, President Trump has
basically shut down the border. We're seeing nothing like the
numbers we saw last year. My hope is that this stops. The
purposeful smuggling of children into our Nation being put into
dangerous situations, that we shut this down.
What can you do to ensure that this never happens again? As
a mother, but certainly as the Attorney General that was
working with agencies desperately trying to promote safeguards
for children, not getting any information, law enforcement was
begging for it. Child Services was begging for it. What will
you do to ensure that this can't happen again?
Mr. O'Neill. Thank you for the excellent question, Senator
Moody. So, in the Bush administration, I worked very closely
with the Office of Refugee Resettlement, especially to fight
human trafficking. I was the HHS representative on the
government wide senior policy and operating group to fight
human trafficking. I'm very proud of the work that we did with
ORR at that time. The focus ORR was a little bit different
then, the human trafficking fight was not as focused on the
border as it obviously has been in the last 5 years.
It is absolutely a priority, and I believe the Secretary
has set it as a priority for him to find all the missing
children and make sure that they're safe. And if confirmed, I
look forward to working with him and the Office of Refugee
Resettlement, as well as other parts of government to ensure
that all children are safe.
Senator Moody. Well, again, remember, it's not just finding
these children. There are regulations in place that facilitated
the government basically becoming traffickers of children. Can
you go in and work immediately to remedy any of those that
either promoted or allowed for these children to be
disseminated across the United States, many never to be heard
from again, placed in incredibly dangerous situations?
Mr. O'Neill. Yes, I can. So traditionally, the role of
Deputy Secretary is heavily focused on regulations, on making
sure that regulations are up to date and appropriate and making
modifications when necessary. And I will absolutely review all
the regulations pertaining to ORR or any other areas that could
affect trafficking or missing children and make sure that
they're appropriate. Thank you,
The Chairman. Senator, Alsobrooks.
Senator Alsobrooks. Thank you so much. Thank you so much
Mr. O'Neill for being here today. And for your Interview, 20
years ago, that there were studies looking at how much lasting
value Head Start gave to children. And I quote that you said
you don't have an updated view on how efficacious it is. You
said also that you didn't have a view on the Head Start program
at this time.
I have to tell you, Mr. O'Neill, that's a really concerning
answer from the person who is interviewing to be leader at the
department, and whose purview will not only be health programs,
but the Human Services program that serve our children's, our
Nation's children, and families. As the Deputy Secretary, you
will be responsible for helping develop the budget request for
programs like Head Start, which is an extremely important
program for so many children and their families and divisions
like the Administration for Children and Families.
My first question is, given your remarks just this last
past week on Friday, regarding not having an updated view on
Head Start. Have you now today, do you have a more--have you
familiarized yourself with the Head Start Program since that
discussion? And do you know how many children are even served
by the Head Start program?
Mr. O'Neill. Thank you for the question, Senator. And by
the way, I really enjoyed our conversation in your office a few
weeks ago. I have not had any input into any discussions about
reorganizations or budget. If confirmed, of course, I would be
happy to, and responsible for digging into every element of
reorganization and budget around all HHS programs. Currently,
I'm a private citizen.
Regarding measles, Senator, as you know, the measles
outbreak began before Secretary Kennedy took office. Since he's
taken office, he has recommended the MMR vaccine to parents,
multiple occasions, including on television. He's also deployed
a CDC task force to Texas and other locations, to take charge
of the measles outbreak. I think both of these actions are
extremely appropriate. I think he's taking measles seriously as
he should. And I support all of that. I support the MMR
vaccine, I support deploying----
Senator Alsobrooks. With all due respect, I only have
another minute. Let me just ask you, Mr. O'Neill, I'm going to
be able to talk to the secretary, I hope next week. I don't
agree that he's taking Measles seriously at all. But I needed
an answer from you. It's important for us to know what you
think about Head Start. And so, I'd just like you to tell me
whether or not you still believe, you're not sure, whether or
not Head Start it's efficacious as you put it.
Mr. O'Neill. Senator, it's essential that children in early
childhood have good appropriate care and cognitive development.
I don't know the best way to do that. It may well be Head
Start. I have not been involved in any discussions around
reorganizing it or moving it or anything like that. If
confirmed, of course, I would be.
Senator Alsobrooks. Okay. And again, this program is so
important, and when the Administration first announced its
funding freezes, Head Start providers were locked out of a
portal. This is of course, devastating. And many didn't know if
they'd be able to even make payroll or continued to operate.
If confirmed, can you commit that the department will send
all Head Start Awards to providers on time, and that this sort
of chaos won't continue to resurface regarding Head Start? We
just need a clear answer about what you intend to do with Head
Start.
Mr. O'Neill. Senator, I've never been a fan of chaos. I
intend to do my best if confirmed to ensure that there's no
chaos in the department or in any part of the department.
Payroll should be always paid on time. And if the department
has made any mistakes, of course it should correct them.
Senator Alsobrooks. Would that include reinstating the
staff who administer the Head Start program and reopen the
closed regional offices that are responsible for overseeing
Head Start programs?
Mr. O'Neill. Senator, I haven't been involved in any of
those discussions. I would say that making sure there's the
right number of people with the right skills in every division
of HHS would be a responsibility.
Senator Alsobrooks. Thank you. Thank you, Mr. Chairman.
The Chairman. Senator Husted.
Senator Husted. Thank you, Mr. Chairman. Thank you, Mr.
O'Neill, for your willingness to serve and provide testimony
today and answer our questions. I look forward to working with
you and the Secretary to improve health outcomes. You do a very
important job.
President Trump recently issued an executive order this
week that would prohibit Federal funding for potentially
dangerous life science research, such as gain-of-function
research, in adversarial countries of concern. For example,
China, which is home of the Wuhan Institute of Virology, and
the SARS-CoV-2 coronavirus that killed people around the world,
closed schools, cost this government at least $5 trillion and
left a wake of devastation behind it. Sometimes small things
can cause big problems, and this is certainly a case where it
did.
I applaud the Administration for these efforts, I think
it's an excellent step to keep Americans and the world safe and
prevent the next pandemic. And I am concerned about
unsupervised high-risk research right here at home though.
Specifically, I am concerned about what we can do to
protect against the misuse of desktop gene synthesizers. I am a
fan of innovation in technology and healthcare. It can do
amazing things, and these devices have the potential to do good
to advance research. They could also though, provide genes for
deadly pandemics, either to state actors or terrorists, and
could be used as a bio weapon. And unlike most commercial gene
sequence providers, a terrorist group or state actor could
synthesize a deadly pathogen with no screen or safeguards in
place.
Looking at this issue through your role and through the
Department of Health and Human Services, what can you say to us
today that can provide some reassurance or guidance on the
framework for how nucleic acid screening captures of a desktop
gene synthesis and researching, occurring outside of the
commercial gene census providers, how will you help make sure
that this is done safely and responsibly in the United States?
Mr. O'Neill. Thank you for the excellent question, Senator.
Gain-and-function research imposes risks on the entire world.
And so, it is not a simple matter of if the money could better
be spent elsewhere. It is a matter of should this research be
done at all, and how to account for the fact that it might be
conducted in other countries that we have little influence
over. Of course, it's appropriate to research on viruses and
microbes so that we are ready to respond to a pandemic
regardless of whether it's naturally occurring or manmade.
But extending that research into gain-of-function research
is a totally different level of risk. My understanding is that
there was an NIH ban on gain-of-function research that I
believe the Obama administration lifted or weakened during its
last weeks before leaving.
Obviously, there's evidence that efforts were made by
various scientists to evade even the rules that existed. It
does look like NIH money made its way into some gain-of-
function research. And if so, that strikes me as completely
inappropriate and something we should work on.
You also mentioned desktop generation of genes. That is a
concern. Overall, I think sophisticated technology is mostly
going to be very beneficial. Artificial intelligence, machine
learning, large language models, neural networks. But of
course, there is potential danger as well, regulation might be
appropriate. One thing I've noticed with regulation of cutting-
edge science is the regulation struggles to be as up to date as
the technology.
I would like to recruit very excellent technologists into
the department in all divisions to ensure that anything we do
to address the risks of gain-of-function research has an up-to-
date technology side as well as regulatory side.
Senator Husted. Thank you. And I'll just add this. With
quantum computing, AI essentially 3D printing types of
technologies that are going to allow us to do some amazing
research on health solutions. I just ask that we make sure
we're doing all that is possible to ensure that it's not used
for nefarious purposes, because we have seen what happens when
either through sinister reasons or through incompetency, it can
definitely have a major impact on our world. Thank you, Mr.
Chairman.
Mr. O'Neill. Thank you, Senator.
The Chairman. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman. And Mr. O'Neill,
thank you for our opportunity to speak prior to this hearing. I
share the deep concern expressed about Health and Human
Services submitting an operating plan, otherwise known as a
spend plan to Congress that includes asterisks, rather than
planned funding levels for over 530 different programs. This is
effectively the Department of Health and Human Services saying
that it doesn't need to tell Congress and the American
taxpayers how it is spending tons of billions of dollars.
With that, we are left to assume that the Department of
Health and Human Services is intentionally hiding what it's
doing, and the results of a massive proposed reorganization,
firing of tens of thousands of employees, terminating billions
of dollars in grants and actively delaying billions of dollars
in funding.
During our meeting, we discussed the importance of
transparency. Secretary Kennedy has pledged what he called
radical transparency, and that is absolutely not what we have
seen. So, Mr. O'Neill, do you think that the Department of
Health and Human Services should tell Congress and the American
public how it is spending taxpayer dollars that we have already
appropriated, yes or no?
Mr. O'Neill. Thank you for the question, Senator. I also
enjoyed our meeting. So, I've not seen this plan that you're
referring to with the asterisk----
Senator Baldwin. I can tell you that it was a long page
asterisks, asterisks, asterisks, no dollar amount, except for a
handful of programs. That is not radical transparency in my
book. Should the Department of Health and Human Services tell
Congress and the American public, if it is, for example,
cutting funding for services through the 988 Suicide and Crisis
Lifeline, yes, or no?
Mr. O'Neill. Senator, I'm a former Senate staffer. I, I
know that it's Congress that authorizes all the programs at
HHS, it's Congress that appropriates the money for HHS,
Congress absolutely deserves prompt and transparent and
accurate information. I stress the prompt part.
Senator Baldwin. What about how many employees have been
fired and the functions that those employees were carrying out,
should that be reported to Congress and the American taxpayers?
Mr. O'Neill. Senator, my understanding of the--is that it
was the decisions of who to lay off were, I think I read, made
by the heads of the operating divisions who are closer----
Senator Baldwin. Should that be reported to Congress?
Mr. O'Neill. Senator, yes. I think so.
Senator Baldwin. Okay. Should the Department of Health and
Human Services tell Congress if it fired, for example,
employees administering clinical trials at NIHs clinical
Center? Yes, or no?
Mr. O'Neill. Senator, I think every significant thing the
department does should be available to Congress.
Senator Baldwin. Mr. O'Neill, if you are confirmed, I will
certainly be following up to ensure that Health and Human
Services makes good on the commitment to transparency. And if
these changes would actually enhance the health and well-being
of Americans, HHS should be eager to explain how and why
instead of what it's doing, which is hiding this information.
HHS has delayed funding for research on treatments for
deadly diseases and for Head Start and childcare programs. It's
decimated offices responsible for carrying out critical
activities, including addressing lead poisoning in children.
Let me just give you an example of how HHS firings are
impacting communities in Wisconsin. The city of Milwaukee
requested assistance through the CDC's Childhood Lead Poisoning
Prevention Surveillance Branch, to help respond to lead
poisoning cases tied to several public-school facilities. The
request for assistance was denied because of a lack of staff
capacity after the entire childhood lead poisoning branch was
fired. This is a clear example of HHS firing affecting critical
program operations.
Without the support, Milwaukee faces lasting implications
of health and well-being of children in the city. If you are
confirmed, I will be following up with you on this, as I have
yet to receive a response from Secretary Kennedy.
The Chairman. Senator Marshall.
Senator Marshall. Thank you, Chairman. And welcome Mr.
O'Neill. It's good to see you again. I was excited yesterday to
see the nomination for President Trump of Dr. Casey Means to be
the Surgeon General, and certainly she is an expert on all
things MAHA and nutrition and metabolism importance of
mitochondria. And I want to relate that to what you mentioned
in your testimony that you're anxious to reform our food system
to prioritize health. And just kind of tell me what that vision
looks like and how can you work with Dr. Means and the other
folks there at HHS?
Mr. O'Neill. Thank you so much for the question, Senator.
And I really enjoyed our meeting a few weeks ago. I note that
you mentioned the word mitochondria. I've noticed that 3 years
ago people didn't know anything about that, they remember from
high school biology. Oh, yes. Mitochondria, the powerhouse of
the cell. But in the past few years thanks to a lot of smart
people talking about metabolism much more than the past, people
are starting to be interested.
Infectious disease is still a very serious challenge to a
lot of people. But metabolism metabolic disorders, chronic
diseases are getting more attention and I think that's
wonderful. I hope they continue to get attention from
researchers, from physicians, from patients.
Regarding the food system, the unfortunate situation today
is that a lot of families really try hard to be healthier and
have healthier habits and it's not easy. They go to the grocery
store; junk food is much cheaper than healthy food. They're not
even sure which food is healthy. Nutrition labels can be
confusing. Official government nutrition advice, the dietary
guidelines that two departments issue every 5 years often seem
to lag by decades. Actual nutrition science, real nutrition
science is so hard to do, because there's so many stakeholders
with an interest in particular outcomes.
I think it's essential that we have good nutrition research
that is free from outside influence. There's a metabolism lab
at NIH that I visited, where you lock people in a room with
their consent for days, measure every calorie that goes in and
goes out, exercise. We need more of that. There was talk a year
ago of shutting that down, I think we should have more of that.
Senator Marshall. Okay. You also mentioned prioritize
health for children and I'm going to just focus for a second on
mental health. I'm not sure if you had the opportunity to read
the book, the Anxious Generation, but if you haven't, I surely
would recommend that you do that. What role do you think social
media apps have played in the mental health of our children and
young adults?
Mr. O'Neill. Thank you, Senator. That's a great concern.
So, companies that develop apps have an interest in maximizing
the amount of time that users spend on the apps. The amount of
engagement, try to hook them into it, that's expected given
that they're trying to grow their business. But that's not
necessarily what's best for users, especially young users.
There's more and more awareness that social media can be an
addiction, and that it especially could have a profound lasting
influence on young, developing brains. Brains seem to keep
developing until age 25. So, people that don't even think of
themselves as children could still be, well, adults could also
suffer negatively. So yes, that is a concern that HHS should
have a role in researching and communicating best practices.
Senator Marshall. Great. Certainly, adds to the loneliness
as well. Maybe the little time we have left, I just want to
emphasize the importance of replicating previous studies.
Again, you mentioned that in your testimony. Over 20 years ago
in NIH study on Alzheimer's took us down in the wrong
direction. And that study was never replicated. So, what does
that look like? I mean, you don't want your best buddy to do
the replication of that surgery. It needs to be another non-
biased person. So how do you implement that plan?
Mr. O'Neill. Absolutely. So, there's two ways a study could
lead us down the wrong road. One is outright fraud, which has
happened in Alzheimer's research. And the other it's kind of
bad luck. You do one study, there was no intention of fraud,
but the results were an unusual combination. The stars were in
a certain alignment, and it's also not going to replicate. So
there's a lot of talk about the replication crisis in all of
science about 10 years ago, and it's still an unsolved problem.
I think NIH should devote--and the problem is no one has a
financial interest in replicating studies. So, NIH should do
that. And I think that would be something that NIH can do best,
whether that should be conducted operationally as one whole
division of NIH focused on replication, or whether there should
be a replication branch in each institute. I'm open to
arguments both ways.
The Chairman. Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chairman and good
morning, Mr. O'Neill. It's good to see you again. Secretary
Kennedy has stated that one of his top priorities is to end the
Fentanyl crisis, which has devastated countless families in New
Hampshire and as you know and all across the country. One
critical tool we have when we are fighting fentanyl is an
overdose reversal medication called Naloxone. Do you agree that
it is important for first responders to have access to
Naloxone?
Mr. O'Neill. Thank you. Lovely to see you again, Senator.
I've very publicly advocated the approval and legalization of
Naloxone for years. And yes, I believe that you never really
know when it's going to be needed. When it is needed, you need
it right there. And yes, I think first responders having it
makes a lot of sense.
Senator Hassan. President Trump has proposed to eliminate a
critical program that arms and trains first responders in my
state and across the country with Naloxone. So, you've just
made the case for why they need to have it. If confirmed, will
you use your position to urge Secretary Kennedy and President
Trump to reverse their cuts to Naloxone funding for first
responders?
Mr. O'Neill. Senator, there are probably a lot of ways to
ensure that Naloxone is deployed locally. I'm not really sure
what the best way to do that is.
Senator Hassan. I can tell you as a former Governor, whose
state was devastated when the fentanyl crisis first began to
hit, that it was absolutely critical to have that Federal
partnership to help fund Naloxone for first responders. State
budgets can be sparse, and this is a really important tool. So,
I hope you will urge Secretary Kennedy to reverse that, or at
least work with states in a transparent way to find out what a
different way of supporting Naloxone supply is. But just to end
it without a plan moving forward, I think will really harm
people and may cost us lives.
Now, I also wanted to turn to another issue that I'm deeply
concerned about, which is Secretary Kennedy's decision to hire
David Geier, an individual with a track record of harming
children. Mr. Geier was disciplined for practicing medicine
without a license, on children who have autism. And now,
secretary Kennedy is paying Mr. Geier with taxpayer funds to
conduct a study at HHS. Mr. O'Neill, if confirmed, would you
advise the Secretary to fire David Geier?
Mr. O'Neill. Senator, thank you for the question. I've
never had any communication with this person. I don't know him.
I would say that all research and research funding decisions
and analysis research, should involve multiple people, ideally
with different backgrounds who are allowed to disagree with
each other.
Senator Hassan. I appreciate that. This is by the way, the
department's Web site that post Mr. Geier as an employee. Do
you have concerns about the Secretary employing an individual
who has been found responsible for harming children?
Mr. O'Neill. Senator, I think that the Secretary is an
excellent judge of personnel and character. He trusted me and I
hope to not let him down if confirmed. And I don't know this
person, so I can't really commit to----
Senator Hassan. Well, what I would like to do is submit by
unanimous consent for the record, this is the State of
Maryland's complaint against Mr. Geier for practicing medicine
without a license on children with autism, including injecting
an 8-year-old with a testosterone suppressant, as some kind of
treatment for autism. So, it is really concerning, and I hope
you will turn your attention to Mr. Geier because----
The Chairman. Was that a request to put it in the record?
Senator Hassan. Yes, it was a request to put in the record.
The Chairman. Without objection.
[The following information can be found on page 27 in
Additional Material:]
Senator Hassan. Last, I guess I'll just finish up this way.
I really hope you will look at Mr. Geier's record, look at the
allegations that were proven in this complaint. He was
disciplined for practicing medicine without a license on
children with autism, and it is deeply, deeply concerning. I
believe he has no place at the country's Premier Health Agency.
Secretary Kennedy also recently made troubling comments
about children with autism. His comments reflected that he
understands very little about people who are living with
disabilities. Instead of taking the time to listen to
individuals with disabilities and their families, Secretary
Kennedy has moved to shut down programs and fire staff who
provide critical support for these families and these
individuals with disabilities.
For example, Secretary Kennedy fired staff that run the
National Family Caregiver Support Program, a critical resource
for people who care for family members with disabilities. Mr.
O'Neill, will the Secretary's actions to gut caregiver support
help children with disabilities?
Mr. O'Neill. Senator as you may know, the Secretary has
made it a priority to research autism. We don't know what
causes autism. We don't know what causes the recent rise in
autism. We don't know the best way. We Actually have----
Senator Hassan. Excuse me, I'm running out of time. We
actually have some really good studies that are leading us to
understand the multiple causes of autism, but doing away with
caregiving for these families and these children is not going
to help them in the way they need. And I hope the Secretary
will reverse course and listen to families. Thank you, Mr.
Chairman.
Mr. O'Neill. Thank you, Senator.
The Chairman. We want to take a 2-minute break. We will
return subject to the call of the Chair.
[Recess.]
The Chairman. The Committee will be back in session, and
Senator Hawley is next.
Senator Hawley. Thank you very much, Mr. Chairman. Mr.
O'Neill, nice to see you. I enjoyed our conversation, our visit
the other day. Let me just start with this. You're familiar, I
think, with the recent insurance claim study regarding
Mifepristone. Is that correct?
Mr. O'Neill. Yes, Senator, I've not read the study, but I'm
familiar with it.
Senator Hawley. This is a study of 865,727 prescribed
Mifepristone abortions, chemical abortions between 2017 and
2023. It's the largest such study of Mifepristone ever
conducted. The only major study conducted now in years. And as
I think the results were really quite startling.
They showed that 10.93 percent of women who use the
chemical abortion drug experience a major serious adverse
health event, like sepsis, infection, hemorrhaging, often
necessitating emergency room visits, often leading to life-
threatening situations. The dramatic result of this, I mean, I
think the takeaway of this is that this is a much, much higher
rate of serious adverse health events than what the FDA
currently reports, 22 times higher than what the FDA has
currently reported.
My question is, in light of this new data, and it is truly
an enormous data set, just an enormous data set, isn't it time
for the FDA No. 1, to put back in place the reporting
requirements of serious adverse health events? As you know, in
2016, the FDA eliminated at the behest of the Obama
administration, eliminated the requirement that physicians and
others report, non-life threatening, but yet serious health
adverse health events. Shouldn't we put those back in place in
light of this data?
Mr. O'Neill. Senator, FDA has a responsibility to ensure
that all drugs are safe and effective. And sometimes new data
comes in and it needs a review. Mifepristone actually has a
REMS, meaning it's been designated for a long time as something
that needs periodic review of safety data. The Secretary's
pledged to do a safety review of Mifepristone and I strongly
support that review.
Senator Hawley. Good. And you'll help him carry out that
review, that safety review.
Mr. O'Neill. Absolutely.
Senator Hawley. This study that, is out just this last
week, just underscores the need for ongoing safety review. And
for a look, I think a fresh look at all the data. Would you
agree with that?
Mr. O'Neill. It does look that way.
Senator Hawley. Would you also agree that it's time for the
FDA as part of that thorough top to bottom review, to think
about reinstating the other longstanding safety protocols on
this drug?
Until the Biden administration eliminated them,
Mifepristone for 20-plus years, had always required physician
dispensing, in-person dispensing, physician follow-up visits,
the Biden administration eliminated all of those things. Now,
telehealth providers, you don't even have to be in this country
now to send this drug, to prescribe it, ``you don't have to be
a doctor.'' You don't have to see your patient. You don't have
to be in America. You can mail it into states regardless of
state law, what state law is, and this is one of the reasons
we're seeing such incredibly high adverse health events, don't
you think it's time to reconsider and to revisit imposing,
putting back in place those longstanding safety protocols?
Mr. O'Neill. Senator, a lot of patients have a lot of
trouble getting prescriptions filled across state lines, even
medicines that have much less safety concerns than this drug.
And of course, every approval that FDA does or reviews can
state the appropriate and inappropriate ways of prescribing or
dispensing a drug. And so that all of that should be subject to
review. Absolutely.
Senator Hawley. Okay, good. All of it is subject to review.
The Secretary was very clear on this that he will conduct a
full-scale safety review. He's required to by law, as you
pointed out. But I think what this latest study shows is that
the information that is coming into HHS, it's time that you
take a serious look at the scope of that information, because,
again, the FDA in 2016 eliminated the requirement to report
much of this. This is why this study is so significant, because
it looks at all insurance claims, 865,000 of them between 2017
and 2023.
Just to be clear, your commitment is you will do a safety
review, you will look at this top to bottom, you will take this
data into account. Do I have that right?
Mr. O'Neill. I believe the Secretary has already committed
to that, and I will promise you to fully support that.
Senator Hawley. Good, Okay. Let me ask you about your work
on conscience protections in an earlier Administration. I think
in one of the Bush administrations, the Bush 43rd
administration, you worked on conscience protection rules for
healthcare providers. Do I have that correct?
Mr. O'Neill. Yes, that's correct. Senator.
Senator Hawley. Would you support reinstating and fully
implementing conscience protections for healthcare providers?
Mr. O'Neill. That would be up to the Secretary and the
President. But if they decide to go in that direction, I would
know exactly how to do it.
Senator Hawley. Would you advise them to do so?
Mr. O'Neill. I believe I already have Senator.
Senator Hawley. Good. And that should be easy because the
Secretary, when he sat right where you were sitting, said
unequivocally, that he supported conscience protections, that
he would put them back into place. The President said he
supports conscience protections. In fact, the President had
them in place in his first Administration. So, I'm glad to hear
that. We'll hold you to that.
Let me talk to you for just a second here. Well, actually,
I'll write Mr. Chairman, I see that I am out of time, and I'm
always so good about obeying my time limits, aren't I, Senator
Kaine?
[Laughter.]
Senator Hawley. I'll have a few--that's a joke. I'll have a
few more questions for you for the record. Mr. O'Neill, thank
you, Mr. Chairman.
The Chairman. What's the Definition of prevarication?
[Laughter.]
The Chairman. My Ivy League trained colleague, Senator
Kaine.
Senator Kaine. Thank you. I appreciate my fellow Rockhurst
High School alum, Josh Hawley for ceding time to me and not
going over. There are two high schools in America that have two
U.S. Senators, James Madison High School in Brooklyn, Bernie
Sanders and Chuck Schumer and Rockhurst High School in Kansas
City, Missouri, Josh Hawley, and Tim Kaine. And I think it
tells us something about the value of a small Catholic
education that a Josh Hawley and Tim Kaine could both be
graduates of Rockhurst High School.
The elephant in the room, before I have a question or two
for you, Mr. O'Neill. I'm concerned and confused that you're
sitting alone at the table today. This was a hearing that was
originally noticed to include the surgeon general nominee, the
circumstances under which she is now not appearing and has had
a nomination withdrawn is puzzling. I don't know whether it was
the behest of the Committee, the White House, or some
combination of both.
But some news accounts suggest that her nomination was
withdrawn because she positively commented about the COVID
vaccine, that it was a blessing from God. The COVID vaccine
development in the first Trump administration was a huge
accomplishment. Operation Warp Speed. The development of that
vaccine in such short time relative to other vaccine
developments at a time when it was critically needed, was a
real plus in my view.
The thought that because she praised it at the time, that
would be a reason to withdraw her nomination troubles me. I
don't know if that was the reason or it was something else, but
that's being mentioned as a reason for the withdrawal. And that
will obviously lead to a lot of questions when the new nominee
is before us.
Mr. O'Neill, you told the Finance Committee the other day
that you supported focusing Medicaid on the populations it was
created to support in the 1960's, and I think everyone on the
Committee believes that. But that opens up a pretty big
question, which is how about folks who have Medicaid because of
the Affordable Care Act and Medicaid expansion.
20-plus million Americans, including more than 670,000
Virginians have Medicaid because of the Medicaid expansion
component of the Affordable Care Act. As you know, Medicaid
expansion is a state option. I think 41 of the 50 states have
embraced Medicaid expansion. Have you made statements in the
past in opposition to the Affordable Care Act?
Mr. O'Neill. I'm not sure Senator.
Senator Kaine. Can you recall whether you've ever advocated
in opposition to the Affordable Care Act?
Mr. O'Neill. I don't recall, Senator.
Senator Kaine. Can you recall whether you've ever stated a
position about the Medicaid expansion part of the Affordable
Care Act?
Mr. O'Neill. I don't believe I have, Senator.
Senator Kaine. Would you agree with me that if there were a
proposal to eliminate the Affordable Care Act, including
Medicaid expansion, that would be a massive and dramatic cut to
Medicaid?
Mr. O'Neill. I don't know, Senator. I haven't looked at the
numbers. There was obviously a lot of discussion in President
Trump's first term about repealing and replacing the Affordable
Care Act.
Senator Kaine. Repealing, we had a vote on a repeal without
a replace. And it failed in the Senate because both Republicans
and Democrats opposed repeal of the Affordable Act without a
replacement. But you acknowledge that 41 states have embraced
Medicaid expansion. States that have Republican Governors and
Democratic Governors, Republican legislatures, and Democratic
legislatures, you acknowledge that, correct?
Mr. O'Neill. I believe that's accurate. Senator.
Senator Kaine. You would not challenge me when I say more
than 20 million Americans have health insurance through
Medicaid expansion. Does that number sound generally in the
right range to you?
Mr. O'Neill. I believe you, Senator.
Senator Kaine. Have you had conversations either with
Secretary Kennedy, President Trump, or any other members of the
Trump administration about repeal of the Affordable Care Act in
a second Trump Presidential term?
Mr. O'Neill. I don't believe I have, Senator.
Senator Kaine. Have you had conversations with anyone in
the Trump administration, including Secretary Kennedy, about
reductions or repeal of the Medicaid expansion part of the
Affordable Care Act?
Mr. O'Neill. Perhaps very briefly, but I don't recall
anything in specific.
Senator Kaine. Would it have been full repeal, partial
repeal, reduction of the subsidies enabling families to afford
Medicaid expansion? Or do you recall?
Mr. O'Neill. I recall general discussions about preserving
the core populations of Medicaid and how that's essential, and
how any changes that Congress might like to make to the
structure of Medicare would be up to Congress, and it would be
HHS's responsibility to implement whatever Congress legislates.
Senator Kaine. Well, I want to dispute the notion that
there is a core recipient of Medicaid and a non-core recipient
of Medicaid. If you're a struggling family, and the only way
that you can afford health insurance for your family and kids
is through Medicaid expansion, that's part of the Affordable
Care Act. You're not a non-core recipient of Medicaid. Medicaid
is helping you and your family, and that to me is a core
responsibility. I yield back, Mr. Chairman.
Mr. O'Neill. Senator, my opening statement, I did point out
that many families struggle to afford health insurance. That is
a continuing problem. And that's what I'd like to address, and
there are probably multiple ways to address it.
The Chairman. For the record, Republicans did have a
replace plan, I helped co-author it. So, for the record.
Senator Hickenlooper.
Senator Hickenlooper. Thank you, Mr. Chairman. Thank you,
Mr. O'Neill, for being here. Thank you for your willingness to
go deeper into public service. You have experience with
companies that are focused on age related diseases and
conditions, Alzheimer's being prominent. And certainly, I share
that interest and been particularly interested in some of the
research around sugar and ultra processed foods that could be
connected to dementia, different types of dementia in later
life.
As you may know, the Trump administration's, NIH funding
cuts and delays have led to a large amount of confusion, some
would call it chaos, particularly at the Alzheimer's Disease
Research Centers. And I mean, let's put it this way, are you
still interested in further research and understanding into the
causes of and possible treatments of Alzheimer's and if so,
will you figure out some way to restore funding to the
Alzheimer's disease research projects being done at NIH?
Mr. O'Neill. Senator, that does absolutely remain an
interest. There are multiple causes of dementia, Alzheimer's,
and Parkinson's, and Lewy bodies are perhaps the three most
well-known. There could be others. There could be others that
we don't know about.
I think it's an open scientific question of how much we
should focus research money more downstream, specifically
Alzheimer's for these dollars, specifically Parkinson's for
these dollars, specifically Lewy bodies for these dollars. And
versus how much we should focus research dollars more upstream
on what potential common factors and common causes, all kinds
of dementia and all kinds of aging damage has. I don't have a
specific answer for that, but it is an area of like
intellectual and operational interest for me and I would love
to engage in that.
Senator Hickenlooper. Good. Glad to hear that. In Colorado
and in a lot of states we worked hard to make access to green
spaces, a natural outdoor environment, recreational
opportunity. It was both an economic priority for outdoor
recreation is a big part of most of the Western states, I'd say
all the Western states, but also as a public health benefit.
And making sure that those who work in outdoor spaces are safe,
I think is a responsibility for all of us and for the Federal
Government.
Nearly all the workers at the National Institute of
Occupational Safety and Health have been laid off, equally at
the same office in Denver. The office in Denver, specifically
focused on occupational health hazards experienced often
uniquely in the West, such as wildfire. If you're fighting
wildfires, what does that particulate and all those noxious
smoke and fumes that you inhale, what are the consequences of
that.
If you're confirmed Mr. O'Neill, how will you prioritize
occupational safety and health, particularly in the West, with
a severely feeble staff? In other words, the, Federal office
has been not quite just destroyed, but significantly reduced.
Mr. O'Neill. Thank you, Senator. That is a huge concern. As
someone who's lived in Marin County, California for the last 14
years, I've had a lot of negative experience with smoke from
wildfires. I stocked up on N95 masks before the Covid pandemic.
I recall trying to understand the distinction between the N95
masks that were approved by FDA versus the ones that were
approved by NIOSH. They seem very similar. I think they are
pretty similar. Of course, it's important that all parts of
government, including state governments, do their best to
prevent wildfires and respond to them and HHS, of course, has a
role.
Senator Hickenlooper. I'm fine with that. And I guess my
question is really, are you going to fight like hell to make
sure you get enough funding so you can do some of that basic
research because it is ongoing and critical.
Last question, and then I'll let you go. As you know, the
National Institutes of Health are the largest funders of
biomedical research on earth. Basic research often informs the
next big discovery, often done in-house at NIH. Many biomedical
companies are not incentivized to do this nuts-and-bolts
research that translates into the big deal. And yet we all
depend on that research.
If confirmed as Deputy Secretary, how are you going to
incentivize private companies and institutions to conduct
research that historically they have depended on NIH for, but
now they are going to have to do on their own?
Mr. O'Neill. I think I agree with the whole premise of your
question very strongly, Senator. Companies have a financial
incentive to do late-stage translational research. They don't
have an incentive to do basic research, which is also harder to
patent. It's important that NIH do very extensive basic
research because almost no one else will.
Senator Hickenlooper. You're going to have a lot of work to
do. Thank you very much.
Mr. O'Neill. Thank you, Senator.
Senator Hickenlooper. I yield.
The Chairman. Mr. O'Neill just a follow-up. In my question,
I asked regarding, there's a current effective mandate of CDC,
if somebody wishes to become a permanent resident of the United
States legally, it is effectively mandated that they receive
vaccines. Would knowing your opposition to mandates, would you
attempt to rescind that?
Mr. O'Neill. Senator, I share a concern about either legal
immigrants or illegal immigrants coming into the country with
an infectious disease or without recommended vaccinations. I've
not had a chance to discuss. I've been focused on most of the
vaccine questions on rules for citizens and advice to citizens.
I haven't had a chance to discuss rules for legal immigrants
with the Secretary. But I would be happy if confirmed to dig in
on that issue.
The Chairman. Well, I will have that as my question for the
record, if you could respond to that before next week. And for
any other senator wishing to ask additional questions,
questions for the record will be due at 5 p.m. tomorrow, May
9th. Thank you, again, to Mr. O'Neill for being here.
The Committee stands adjourned.
ADDITIONAL MATERIAL
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
QUESTIONS FOR THE RECORD
Responses by James O'Neill to Questions of Senator Cassidy
senator cassidy
Vaccine Requirements
Question 1. Currently, refugees resettling to the U.S. are not
statutorily required to be vaccinated. However, CDC ``strongly
recommend[s]'' that refugees receive routine vaccinations before travel
to the U.S. ``to protect health, prevent morbidity and travel delays
due to disease outbreaks, and to facilitate earlier school enrollment
for children after arrival.''
Do you support requiring refugees, prior to their arrival in the
U.S., to receive the same vaccines against vaccine-preventable diseases
that are statutorily required for aliens lawfully seeking admission as
an immigrant or seeking adjustment of immigration status to become a
lawful permanent resident under Section 212(a)(1)(A)(ii) of the
Immigration and Nationality Act? Alternatively, do you support
requiring refugees to receive these vaccines within 1 year of their
arrival to the U.S. to continue to maintain their lawful refugee
status?
Question 2. Currently, illegal aliens are not required to be
vaccinated even if they are detained by immigration enforcement
authorities. Therefore, unvaccinated illegal aliens who are released
from detention into the U.S. are at risk of spreading infectious
diseases.
Do you support requiring illegal aliens detained and in the custody
of Immigration and Customs Enforcement or Customs and Border Protection
to receive the same vaccines against vaccine-preventable diseases
outlined in question 1 prior to their release from detention?
Answer 1-2. I support and will follow the law. I share your desire
to ensure illegal immigrants are not bringing diseases into our country
and, if confirmed, will evaluate applicable HHS policies and legal
authorities. President Trump explicitly acknowledged this threat in his
January 20, 2025 Executive Order entitled ``Guaranteeing the States
Protection Against Invasion, and I commit to working with you and the
Department of Homeland Security to ensure that aliens--whether legal or
illegal--in no way threaten the health of the American people.
______
Responses by James O'Neill to Questions of Senator Hawley
senator hawley
Question 1. In his first term, President Trump issued his ``most
favored Nation'' prescription drug pricing rule to prevent Medicare
from paying prices multiple times higher than what other countries pay.
He is reportedly planning to revive this policy.
(a). If confirmed, will you fully implement the President's
drug pricing agenda, including his ``most favored Nation''
policy?
(b). If confirmed, will you commit to using every tool at your
disposal to deliver the best drug prices possible for
Americans?
Answer 1(a)-(b). The President has committed to lowering the price
of drugs for all Americans. If confirmed, I look forward to working
with you to ensure that all the dollars in the American healthcare
system are devoted to working for the patient--including lowering the
price of drugs by ensuring transparency in costs, providing
accountability to middlemen, looking for innovative ways to provide
high-cost drugs at low prices, and making sure other countries pay
their fair share for prescription drugs.
Question 2. Do you support restoring the first Trump
administration's Title X rule--known as the Protect Life rule--which
bars Title X dollars from going to organizations like Planned
Parenthood that promote abortion?
Answer 2. I would fully implement President Trump's agenda on the
issue of life. That includes President Trump's Executive Order on
Enforcing the Hyde Amendment to stop taxpayer dollars from funding or
promoting abortion. If confirmed, I will also carry out the Protecting
Life in Global Health Assistance policy and work to strengthen
enforcement of Federal conscience laws.
Question 3. If confirmed, how do you plan to use your position to
limit consolidation in the healthcare industry, which often harms rural
providers?
Answer 3. If confirmed, I look forward to working with Congress and
the FTC to evaluate and address market consolidation issues and ensure
high quality care and good prices for American patients.
______
[Whereupon, at 11:22 a.m., the hearing was adjourned.]
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