Warren Demands Health and Human Services Nominee Erase Ethics Conflicts with Pharmaceutical, Biotech Companies

As RFK Jr.’s Deputy, O’Neill would have insight and influence over FDA approvals
“Your relationships with biomedical companies regulated by HHS will raise concerns about your impartiality in this role”
Text of Letter (PDF)
Washington, D.C. —U.S. Senator Elizabeth Warren (D-Mass.) wrote to Mr. James O’Neill, nominee for Deputy Secretary of the Department of Health and Human Services (HHS), asking him to recuse himself from matters involving companies he has worked with, given many of those companies may seek the Food and Drug Administration’s (FDA) regulatory approval during his tenure. Senator Warren also asked Mr. O’Neill to commit not to take a job in the industries regulated by HHS for at least four years after leaving office and not to lobby HHS for at least four years after leaving office. The Senate Finance Committee will vote on advancing O’Neill’s nomination on Thursday, May 15, 2025.
O’Neill, a “close ally” of Trump-backer Peter Thiel, once managed one of Thiel’s venture capital firms, Mithril Capital Management, where he invested in biotech companies developing medical robots, diabetes treatments, antibody technologies, and more.Some of these companiesare nowseeking FDA approval. After O’Neill left the company, the Federal Bureau of Investigationinvestigatedthe firm for potentially defrauding its investors.
As Deputy HHS Secretary, O’Neill would have insight into and influence over the FDA’s approvals process and could potentially sway HHS’s decision-making to favor companies with which he has worked. O’Neill advises and serves on the board of ADvantage Therapeutics, a pharmaceutical company developing an Alzheimer’s drug that will require FDA approval. He has agreed to recuse from matters related to ADvantage for one year (or two years if he receives a bonus from the company), but “after just one or two years, [his] relationship with the company will remain fresh enough to raise serious impartiality concerns.” Given that,Senator Warren urged, “To mitigate even the appearance of a conflict of interest, you should agree to recuse forfour yearsfrom [matters related to the company].”
Former HHS officials, includingformer FDA Commissioner Robert CaliffandNIH Director Monica Bertagnolli, agreed to recuse themselves from their former clients’ matters for four years — beyond the two-year recusal required by the Biden administration.
O’Neill’s ties to the pharmaceutical industry also raise concerns about his post-government employment prospects. As a result, Senator Warren asked him to commit not to work for any company he regulates or otherwise interacts with during his time at HHS for four years after leaving government service.
If O’Neill were to take a job in the industry, “the public would reasonably question whether the decisions [he] made in office were influenced by the prospect of future compensation from a company [he] regulated,”said Senator Warren.
“The public may also question whether you were cashing in on your executive-branch connections and government expertise to help your new company benefit from insider information to skirt rules that you helped oversee or to curry favor with HHS and/or its subagencies,”the senator continued.
Senator Warren reminded O’Neill that both former FDA Commissioner Califf and former NIH Director Monica Bertagnolli agreed to these post-government employment restrictions. Even HHS Secretary Robert F. Kennedy Jr., who refused to give up some of his egregious conflicts, stillagreed not to work fora drug company after leaving office.
Finally, to mitigate concerns about the revolving door of former government officials lobbying the agencies they once led, Senator Warren pushed O’Neill to commit not to lobby HHS for four years after leaving office, similar to the agreements made by multiple Biden appointees, including Defense Secretary Lloyd Austin, Internal Revenue Service Chief Counsel Marjorie Rollinson, and Treasury Assistant Secretary for Investment Security Paul Rosen.
“The rampant revolving door of former government leaders lobbying the agencies they once led, while their government relationships remain fresh, erodes Americans’ faith in the federal government,”said Senator Warren.
Senator Warren asked O’Neill to answer these ethics commitment requests on the record, including whether he plans to accept any future payment from the companies he’s tied to, by May 14, 2025.
Senator Warren has been a leader on enforcing government ethics standards and pressing nominees to address conflicts of interest:
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