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47 Groups Urge Senators to Oppose O’Neill’s Nomination

March 2024

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Dear Senator,

President-elect Donald Trump has nominated Jim O’Neill to be deputy secretary of the Department of Health and Human Services (HHS), a position subject to Senate confirmation. The undersigned organizations believe O’Neill’s attitudes and prior experience make him a dangerous pick and urge you to vote against his confirmation.[1]

If confirmed, O’Neill would be the second-in-command of a department tasked with ensuring and enhancing the health and well-being of every American. HHS and its subagencies play a critical role in protecting public health through the provision of health care coverage, the regulation of food, tobacco, drugs and other medical products, the prevention and control of infectious and chronic diseases, and more. O’Neill is a long-time venture capital investor with concerning views that reflect his significant financial ties to the for-profit biomedical sector.

Although O’Neill does not have an extensive public record on public health, he has made shocking and extremist statements that should disqualify him for the HHS deputy secretary position. He has disparaged the core work and principles of the Food and Drug Administration (FDA). He has wrongly stated that “regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy.”[2] In fact, the FDA plays a crucial role in preventing dangerous and ineffective drugs and devices from coming to market. When functioning properly, the FDA benefits consumers and manufacturers alike by scientifically evaluating the safety and effectiveness of medical products.

Even more disturbingly, O’Neill has said that the FDA should approve drugs after their sponsors have demonstrated safety but not efficacy, and “let people start using them, at their own risk.”[3] Not only would such an approach threaten to reverse a century of progress for drug regulation in the United States, it also indicates a fundamental misunderstanding of the FDA approval process. Pharmaceuticals receive marketing approval based on their risk-benefit profile, which takes into account both safety and a determination that a drug’s benefits for a specific approved use are sufficient to outweigh its adverse effects.

O’Neill has also disparaged the FDA’s essential role in the regulation of diagnostic tests that rely upon computer algorithms. According to reporting from Bloomberg in 2016, O’Neill served in the George W. Bush Administration at HHS and had some oversight over “complex laboratory developed tests.” O’Neill reportedly opposed advancing such regulation, partially clarifying his position with the following statement:[4],[5]

“In order to regulate in this space, FDA had to argue that an algorithm, a series of numbers that match up to things, is a medical device. I found that really astonishing – astonishing that someone could say it with a straight face, and astonishing that someone could claim the ability to shut down companies that were never touching a patient but only accurately matching algorithms.”

Medical devices that use artificial intelligence are now poised to have broad effects on medical practice from the diagnoses and treatment of patients to insurance claim processing.[6] To safeguard the nation’s health, thoughtful and responsible oversight of artificial intelligence is essential for both the FDA and HHS.

O’Neill’s views align with his business interests. After his service at HHS, O’Neill led investment funds that backed for-profit biomedical companies developing pharmaceuticals, software algorithms used within medical devices, and medical robotics, among other health technologies.[7],[8] If O’Neill’s deregulatory views are implemented as HHS regulations and policies, such companies would likely benefit.

If O’Neill becomes the deputy HHS secretary, we are concerned that new drugs, devices and other medical products may reach the market more rapidly, but with insufficient review of their safety and effectiveness.

Moreover, while he has a limited public record of comment on health issues broadly, his dangerous and misinformed views about the workings of the FDA provide deep cause for concern that he will prioritize ideological and corporate profit considerations over the public health mandate of the Department.

Based on the available record, O’Neill would be a bad choice to serve as the deputy HHS secretary. The American people deserve a better qualified nominee with an extensive public record that reflects a commitment to uphold scientific and public health principles. We urge you to vote against O’Neill’s confirmation.

Sincerely,

National Organizations

314 Action
ACA Consumer Advocacy
American Muslim Health Professionals (AMHP)
Autistic Self Advocacy Network
Beta Cell Action
CenterLink: The Community of LGBTQ Centers
Consilium Scientific
Defend Public Health
Doctors for America
Healthcare NOW
Jacobs Institute of Women’s Health
Labor Campaign for Single Payer
Maryknoll Sisters
MomsRising
National Latina Institute for Reproductive Justice
National LGBTQI+ Cancer Network
NBJC
Not Putting on a Shirt
Nurses for America
Oregonizers
People Power United
People’s Action
Popular Democracy in Action
Public Advocacy for Kids (PAK)
Public Citizen
The Center for Science in the Public Interest (CSPI)
Universities Allied for Essential Medicines
Voices for Progress
Voices of Health Care Action

State and Local Organizations
Act for Democracy
AIDS Foundation Chicago
AIDS Resource
Citizen Action/Illinois
Doctors Organized for Health Care Solutions
Equal Hope
Healthcare is a Human Right WA
Indivisible Marin
One Eyed Jacks
Prevention Point Pittsburgh
PSARA (Puget Sound Advocates for Retirement Action)
Public Health Advocates
Rise Up WV
TIP Action
UNC Gillings School of Global Public Health
Unity Fellowship of Christ Church-NYC
VOCAL-NY
Washington Community Action Network

 

[1]Public Citizen. Jim O’Neill: unfit to be the #2 health care leader in America. December 18, 2024. https://www.citizen.org/article/jim-oneill-unfit/

[2]Toward a New Investment Paradigm – Panel Discussion. Rejuvenation Biotechnology 2014 meeting video. Posted by the SENS Researcher Foundation. https://www.youtube.com/watch?v=CinMTzo1i80. (17:30)

[3]Kaplan S. Trump considers naming FDA chief who would radically overhaul the agency. STAT News. Dec. 7, 2016. https://archive.ph/mC88a.

[4]Armstrong D. Trump Team Said to Consider Thiel Associate O’Neill for FDA. Bloomberg. Dec. 7, 2024. https://archive.ph/IXEdX.

[5]Keown A. Peter Thiel touts ally for top job at the FDA or a role at HHS. Biospace. December 8, 2026. https://www.biospace.com/b-peter-thiel-b-touts-ally-for-top-job-at-the-fda-or-a-role-at-b-hhs-b.

[6]Kemp E. Promise and peril: artificial intelligence in health care. November 21, 2024. https://www.citizen.org/article/promise-and-peril-artificial-intelligence-in-health-care/.

[7]Diamond D. Jim O’Neill, Silicon Valley investor, favored for HHS deputy secretary. The Washington Post, November 25, 2024. https://archive.ph/RVM7d.

[8]Mithril Capital Webpage. www.mithril.com.