FDA nominee Overton dodges questions on Trump influence

FDA Commissioner nominee Heidi Overton deflected multiple questions about her willingness to stand up to pressure from President Trump at a Senate hearing in which she was quizzed on a range of issues, including vaccines, the abortion pill, and agency reforms.

Members of the Senate Health, Education, Labour, and Pensions (HELP) committee on both sides of the aisle repeatedly asked the White House aide if she would stand up to Trump if he asked her to do something illegal or that she did not support, to which she replied she would "follow the statutory requirements" of the FDA and give the President her "best advice."

Worryingly, Overton seemed unable to acknowledge that Trump could be wrong on any issue – even though she was present when he asserted that the MMR vaccine was "quite lethal," for example, and also when he said it should be split into three separate shots – raising fears that she may be yet another federal appointee selected for a slavish loyalty to the President.

"It is the president who sets the policy directions, but he works with all of his advisers to get the best information," she hedged, and then promptly contradicted Trump by asserting that the MMR vaccine "is not lethal" and – like all other vaccines currently on the US market – is "safe and effective."

Similarly, Overton said there was no evidence that Tylenol (acetaminophen) was linked to autism, but refused to say that Trump was wrong when he said last year that pregnant women or young children should not take it.

HELP chair Sen Bill Cassidy (R-La), who cast the deciding vote that allowed vaccine sceptic Robert F. Kennedy Jr to become HHS Secretary, said that he would not vote for Overton if she could not say clearly that Trump was wrong. "Kennedy gave me guarantees, and he did not keep them," said Cassidy.

A physician by training, Overton has helped shape the Trump administration's healthcare policies and played an advisory role in the decision to slash the recommended childhood immunisation schedule from 17 to 11 jabs, which was ruled unlawful by a federal judge earlier this year.

Abortion pill views

Several lawmakers asked Overton about her position on the abortion pill mifepristone, access to which has been rolled back in many US states during Trump's second term, with reference to her previous comment that it was "dangerous to women" in a paper published whilst working at the America First Policy Institute.

She declined to say whether she personally believes mifepristone is safe, despite decades of use, and in the past has called for tighter regulation on the drug, describing it as "teleabortion" and "abortion-on-demand."

She would only say that mifepristone "was approved by the FDA as having met its safety and efficacy standard," adding she would not prejudge the findings of an ongoing review at the FDA. Cassidy could be an ally on this issue, as he is among those lawmakers pushing for the reversal of rules that allow mifepristone to be prescribed via telemedicine.

Independent advisory committees

Overton pledged her support for the independent advisory committee process, stating that these panels would remain a critical part of the FDA's regulatory review process, which does run somewhat counter to the recent moves by HHS under Kennedy to scale back or limit the use of these panels, doing away with them altogether in some cases.

Trump's nominee would not, however, commit to restarting advisory committees that have been abandoned – which include panels covering arthritis, medical imaging drugs, pharmaceutical sciences, and patient engagement – or commit to not shutting down any others.

Competition with China

In her opening remarks, Overton said that a key part of her role at the FDA would be to introduce regulatory reforms that would help to counter the rapid emergence of China as a source of new medicines, noting that Trump has instructed her to "go fast" on this to prevent investment "increasingly flowing to China, [which] has found ways to do things faster and cheaper."

"If confirmed as commissioner of food and drugs, I will immediately set my focus to restoring the primacy of American innovation while furthering the core missions of advancing national security, increasing access to affordable treatments, and promoting public health," she told the senators.

If confirmed, Overton would succeed Marty Makary, who stepped down as FDA Commissioner in May. The agency has been led on an acting basis by Kyle Diamantas since Makary resigned, after 13 months in the role.