US Senate News:
Source: United States Senator for Massachusetts – Elizabeth Warren
May 13, 2025
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 companies are now seeking FDA approval. After O’Neill left the company, the Federal Bureau of Investigation investigated the 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 for four years from [matters related to the company].”
Former HHS officials, including former FDA Commissioner Robert Califf and NIH 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, still agreed not to work for a 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:
In March 2025, Senator Elizabeth Warren wrote to Marty Makary and Jay Bhattacharya, nominees to lead the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), respectively, asking them to address their conflicts of interest ahead of their confirmation hearings.
In February 2025, Senator Elizabeth Warren and Tim Kaine (D-Va.) called on Mr. Robert F. Kennedy Jr. to recuse himself from former clients’ and employers’ particular matters and commit to not lobbying HHS after his tenure as Secretary.
In February 2025, following the Senate Finance Committee vote to advance the nomination of Mr. Robert F. Kennedy Jr. for Secretary of Health and Human Services, Senator Elizabeth Warren gave remarks regarding the nominee’s continued conflicts of interest.
In February 2025, Senators Warren and Ron Wyden (D-Ore.), Ranking Member on the Senate Finance Committee, wrote to Mr. Robert F. Kennedy Jr., pressing him to urgently resolve his serious conflicts of interest before the committee vote Wednesday morning.
In January 2025, following pressure from Senate Democrats, Mr. Robert F. Kennedy Jr. agreed to amend his flawed ethics agreement (see Warren QFRs at the end of Part 2 and start of Part 3).
In January 2025, at a hearing of the Senate Finance Committee, Senator Elizabeth Warren questioned Mr. Robert F. Kennedy Jr., nominee for Secretary of Health and Human Services, about his dangerous conflicts of interest and record of profiting from anti-vaccine conspiracies.
In January 2025, ahead of Mr. Robert F. Kennedy Jr.’s confirmation hearing for Secretary of Health and Human Services, Senator Elizabeth Warren sent a 34-page letter detailing her concerns with his nomination and asked him to answer 175 questions ahead of his hearing before the Finance Committee.
In January 2025, Senator Elizabeth Warren wrote to Trump Transition Co-Chairs Howard Lutnick and Linda McMahon, urging them to make the White House’s ethics pledge for incoming appointees as strong as possible and outlining specific provisions to do so. The letter came at the end of the first week of confirmation hearings for President-elect Trump’s cabinet nominees, many of whom have been found to have serious conflicts of interest and massive wealth.
In December 2024, Senators Elizabeth Warren, Ron Wyden (D-Ore.), Dick Durbin (D-Ill.), Jeff Merkley (D-Ore.), and Representative Lloyd Doggett (D-Texas) wrote to Dr. Mehmet Oz, President-elect Donald Trump’s pick to lead the Centers for Medicare & Medicaid Services, raising stark concerns about his advocacy to eliminate traditional Medicare and his deep financial ties to the private health insurers that would benefit from that move.
In November 2024, in response to the news that President-elect Donald Trump selected Robert F. Kennedy Jr. to serve as Secretary of Health and Human Services, Senator Elizabeth Warren released a statement calling him a “danger to public health, scientific research, medicine, and health care coverage for millions of Americans.”
In January 2022, Senator Elizabeth Warren secured a commitment from then-FDA Commissioner nominee Dr. Robert Califf to recuse himself from matters involving his former employers and clients for four years, two years longer than what was required in the Biden administration’s Ethics Pledge. He also agreed not to seek employment with or compensation, including as a result of board service, from any pharmaceutical or medical device company that he interacts with during his tenure as FDA Commissioner for four years after completing his government service.
In December 2020, Senator Elizabeth Warren and Representative Jayapal introduced the Anti-Corruption and Public Integrity Act, the most ambitious anti-corruption legislation since Watergate, which would outlaw corrupt revolving-door schemes so that public servants are serving the public – not the financial interests of themselves or giant corporations.
In March 2020, President Trump signed the bipartisan Presidential Transition Enhancement Act into law, which included major provisions of Sen. Warren’s (D-Mass.) Transition Team Ethics Improvement Act.
In September 2019, the Senate passed a key provision of the Transition Team Ethics Improvement Act introduced by Senators Warren and Tom Carper (D-Del.) to enhance the ethics requirements that govern presidential transitions.
In November 2016, as President Trump prepared to take office, Senator Elizabeth Warren and Chairman Cummings requested a GAO investigation of the chaotic Trump transition. In September 2017, Government Accountability Office (GAO) released the results of the investigation, finding that the Trump transition team ignored advice from the Office of Government Ethics and failed to follow past precedents regarding ethics and presidential transitions.
