Experts say RFK Jr. could play big role in Trump 2.0, FDA leadership to face scrutiny

The changes discussed by President-elect Trump and his supporters during and after the election could fundamentally change the way the US Food and Drug Administration (FDA) operates, experts said in interviews with Focus.

“I think the big difference this time is [President-elect Trump and his supporters] are much more explicitly talking about FDA changes in sweeping ways in terms of personnel, in terms of radical policy changes, at least different from the past,” Daniel Kracov, a partner at Arnold & Porter and chair of its global life sciences industry group,told Focus. “That opens up our historical assumptions about FDA and its role and what it does and so forth.”

President-elect Trump has long railed against what he calls “the deep state” and has sought to shrink the size of the federal government. According to Kracov, that could impact the number of people working at the FDA, the agency’s ability to hire and retain talent, and its oversight of products coming to market. He also said he expects a lot more top-down management of the agency from the White House and Department of Health and Human Services (HHS).

“I suspect that the leadership at FDA is going to be very vulnerable at all levels,” said Kracov. “I think it's going to also be difficult to recruit and retain people if the FDA is under attack.”

He said FDA may face a “brain drain” if staff feel the agency is under attack and its norms are not being respected. “It's going to be an interesting dynamic in terms of people leaving and people being pushed out,” he added.

Former presidential candidate Robert Kennedy Jr. has been touted as a potential advisor to Trump on healthcare matters, and recently told MSNBC News that “entire departments” at FDA “have to go.” In particular, he singled out FDA’s “nutrition department” for not protecting children.

Kracov said that Kennedy could have a significant impact on FDA under a Trump Administration. “It sounds pretty fundamental the way they’re talking, and we'll see what actually happens,” he said. “My sense is he may play more of a presidential council type of role, more of an advisor type of role, where he is placing his influence throughout the infrastructure… He’s a disruptor, and that’s the role he’ll likely want to play.”

Cybil Roehrenbeck, a partner at Hogan Lovells who leads its health care lobbying practice, and other Hogan Lovells attorneys presented a list of potential Trump cabinet officials and senior staff based on what they've been hearing during a webinar on 11 November. In addition to Kennedy, they listed Florida Surgeon General Joseph Ladapo, who has questioned the safety of COVID-19 vaccines; and Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, who has advocated for leadership change at FDA and voiced concerns about certain aspects of vaccination for children. They also noted that past Trump officials, such as Demetrios Kouzoukas, who served at the Centers for Medicare and Medicaid Services; Brian Blaze, who served on the National Economic Council; and Joe Grogan, who served on the Domestic Policy Council; could return in the new administration.

Mahnu Davar, another partner at Arnold & Porter, told Focus that during Trump’s first presidency, his administration proposed structural reforms to weaken the civil service in general because the administration argued many decisions were being made by people who were embedded within government.

“Those things were largely set aside by [the Biden Administration], and I would imagine that in terms of some of the levers that a new administration could pull even without congressional action could be looking at the way that FDA is structured and who makes decisions, particularly final decisions on science in certain areas like food, like vaccines, like other areas in public health,” said Davar.

There are several key FDA-specific reforms that the Hogan Lovells attorneys said they expect, including a review of FDA officials' roles in product approvals, more transparency in how products are approved, and new measures to preclude FDA officials from being employed at FDA-regulated companies and vice-versa.

Despite changes the Trump Administration may want to implement, Kracov said the medical products industry wants a strong FDA and will likely support maintaining current regulatory processes and rigor. He added that the modern biomedical industry is based on the regulatory bar set by FDA, which means they and payors can rely on the safety and efficacy of products that get to market.

“It’s extremely valuable to have an arbiter like FDA, and people in the industry understand that even though they complain about FDA sometimes,” said Kracov. “It gives them certainty, a process, and standards, and their competitors have to follow the same process and standards, and payors will recognize that standard as producing data that warrants payment for the product.”

Davar agreed and noted that there are business reasons to ensure FDA continues to operate the way it has.

“For medical products in particular, that FDA review is tied to other important legal concepts and protections, in some cases exclusivity, in some cases patents, in some cases affirmative defenses that can be raised in product liability actions, which are not under the control of the FDA or the executive branch,” he said. “Particularly in the medical product area… I think there will be an interest in having a rule of reason at least applied to changes that are made.”

Kracov said some Biden Administration executive orders, specifically the executive order on artificial intelligence (AI), will probably be rescinded. He noted that the Trump team has already said they have their own thoughts on AI policy that focuses on supporting innovation and promoting free speech. He also added that major campaign donors and advisers to Trump, including Elon Musk and venture capitalist Peter Thiel, could have a big influence on the administration’s AI policy.

Kracov also said another key figure to watch is Vivek Ramaswamy, an early presidential contender who founded the pharmaceutical company Roivant Sciences, and is seen as a close Trump adviser.

“He’s obviously familiar with the FDA approval process and has some views on that… that really could change the process,” he said.

One of the most controversial issues FDA has tackled, especially over the past couple of years, is finalizing a rule to phase in oversight of laboratory-developed tests (LDT). While the agency is concerned about the efficacy of the tests, which have traditionally been under the purview of the Clinical Laboratory Improvement Amendments (CLIA), the clinical laboratory industry has pushed back on the issue as government overreach and is suing FDA to prevent it from implementing the rule.

Davar expects the Trump Administration to be willing to withdraw the rule, which means the lawsuits will be vacated. However, that will not solve the overarching question of how to regulate LDTs and could spur some modest regulatory oversight of testing.

“I don’t think that there’s going to be an administration interest in certainly keeping or expanding any of FDA’s proposals in that area at this point,” he said. “But it’s hard to venture to guess what happens with the whole LDT issue.”

Members of Congress have tried for years to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act to create a regulatory framework for in-vitro diagnostics (IVD) and institute a new pathway for LDT oversight. The bill came very close to passing in December 2022, but failed after opposition from Rep. Cathy McMorris Rodgers, R-WA, chair of the House Energy and Commerce Committee.

Kracov said diagnostics reform may be back on the plate and has a better chance of passing, especially since Sen. Bill Cassidy, R-LA, is slated to take over as the chair of the Health, Energy, Labor, and Pensions (HELP) Committee, and has already given his support for the VALID Act.

Davar agreed that Congress may pass some version of the VALID Act, but it will depend on whether stakeholders continue to fear FDA oversight of LDTs, which initially drove support for the bill. If stakeholders do not fear FDA oversight of LDTs over the next four years, there may be competing priorities, such as deregulation, that puts diagnostics reform on the back burner.

“It’s a wait-and-see issue for sure,” said Davar. “The LDT rule is unlikely to survive in its current form.”

Davar said there could be unprecedented opportunities to shape the FDA’s priorities and thinking. While the industry wants certainty, stakeholders could have the opportunity to proffer new solutions that would not have been well received in previous administrations.
Roehrenbeck said that she expects the Trump Administration to use the Congressional Review Act (CRA) to overturn some federal rules promulgated within 60 legislative days of the new Congress starting. To rescind the most recent rules, the new Congress must pass a disapproval resolution with a simple majority.

She noted that historically, the CRA has not been used extensively, but when Trump became president in 2016, Congress used the law to undo several Obama regulations. She also added that government agencies knew the claw back was a possibility, which is likely why the Biden Administration hasn’t published significant regulations recently.

"One thing that we've been doing, and I know the transition team and folks on the Hill are doing, is looking at what regulations were finalized during that period of time," said Roehrenbeck. "Essentially, from the late summer on, anything that was finalized could be subject to the CRA claw back if it's something that the new Congress and the administration feels should be clawed back."

Experts say RFK Jr. could play big role in Trump 2.0, FDA leadership to face scrutiny

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