FDA Science, Vaccine Policy to Face ‘Firm Hand’ in Trump Return

The FDA is susceptible to a reshuffle under President-elect Donald Trump, whose plans to “Make America Healthy Again” would have ramifications for an agency responsible for drug approvals and food and cosmetics safety.

“I expect him to put a firm hand on agencies like the FDA,” said Lawrence Gostin, co-faculty director of the O’Neill Institute for National and Global Health Law. “Trump has made very clear that he wants to influence, if not control, federal health and scientific agencies.”

Trump hasn’t revealed details of his agenda, but his promise to allow vaccine skeptic Robert F. Kennedy Jr. to “go wild” on health care puts the focus on the FDA’s role in vaccine policy, abortion medication access, and even the science that underpins its work.

“His influence and that of a potential RFK Jr. in his inner circle could try to appoint officials at the agency and influence them on key scientific issues, particularly on vaccinations and abortion medications like mifepristone,” Gostin said.

Vaccines, Mifepristone

Kennedy has made remarks signaling major changes to the agency if he were to take leading role, including comments he shared in October on X, formerly known as Twitter.

“FDA’s war on public health is about to end,” he wrote Oct. 25. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”

In his latest comments, made Wednesday during an interview with MSNBC, Kennedy warned that “entire departments” in the FDA “have to go.”

Kennedy’s skeptcism toward vaccines could result in changes in how the agency oversees the products, said Dorit Rubinstein Reiss, professor of law at University of California San Francisco College of the Law.

“The FDA licenses vaccines and can undo licenses. It would require a major change of personnel and could be vulnerable to court challenges, but if Kennedy gets to nominate someone who’s hostile to vaccines at the FDA, maybe they’ll try to revoke some of the licenses of existing vaccines,” she said.

“That would be one action that would really deny people access to vaccines.”

Similarly, Trump’s vague remarks on access to the widely used abortion pill mifepristone set the stage for a policy change in his next term.

The US Supreme Court in June preserved full access to the pill when it held that medical doctors’ challenging the FDA’s loosened restrictions on it didn’t have standing.

“He might try to influence the agency,” Gostin said. “I don’t think to withdraw the approval, but I think withdrawing the expansion of access, such as the use of telemedicine.”

Scientific Work

The agency could also face pressure in its every day practices, according to Richard Hughes, a member at Epstein Becker & Green P.C.

“At FDA, there are things that are set in stone for the Federal Food, Drug, and Cosmetic Act—basic activities that FDA has to carry out,” Hughes said. But “a lot of FDA policy is contained in those nonbinding guidances, which could all be changed very easily.”

“It remains to be seen on what he could do around food and tobacco,” Hughes added. “Also, the potential injection of very subjective views on evidence into an agency that is focused on safety and efficacy of the products it evaluates would be very concerning.”

Regardless of Kennedy’s role with the FDA, health law watchers say the Trump administration is likely to face a difficult road to accomplish some of its goals.

“The FDA is the quintessential scientific agency, and even if he could appoint loyalists that would decide to question vaccines or reduce access to mifepristone, they would need to have some scientific justification for doing it,” Gostin said.

“If the FDA just flipped on a policy issue and they didn’t have good scientific reason to do it, the courts would react negatively.”

It’s also important to remember that Congress plays a key role in what FDA can do, according to Christine P. Bump, a principal at Penn Avenue Law & Policy.

“Trump obviously has communicated very different priorities and different agendas with respect to federal agencies and recently the FDA in particular,” Bump said. “But campaign promises are one thing, and being able to affect change, let alone wholesale change, is very different.”

“Any new authority FDA would want has to be granted to it by Congress,” she said.