Trump may hand control of FDA over to RFK Jr. Here’s what that could mean for FDA and industry

Remarks by former President DONALD TRUMP at campaign events this past weekend indicated he’d be willing to have longtime vaccine skeptic and pharmaceutical industry foe ROBERT F. KENNEDY JR. head up much of his health portfolio. Kennedy has already said that FDA staff should be prepared to “preserve your records” and “pack your bags,” indicating that the regulatory status quo could be significantly disrupted if Trump wins next week’s presidential election.

What Trump has said about Kennedy’s role for FDA

• So far this election cycle, FDA regulatory policy as a topic area has been mostly absent from both the Presidential and Congressional campaigns. While that’s not surprising historically – the FDA rarely ranks as high as pocketbook issues, health insurance coverage or other hot topics like national security – it is a significant departure from the last Presidential campaign, when both candidates were running on platforms intended to bring the Covid-19 pandemic under control. Then-candidate JOE BIDEN ran on, and then implemented, a plan that called for support of (and reforms to) FDA, including the review of variant-specific versions of vaccines and treatments.
• And while there have been scattered mentions of FDA-related policies, such as the agency’s regulation of the abortion drug mifepristone, we hadn’t heard much from candidates on the FDA, its policies, its actions or its leadership.
• That dynamic seems to have changed as of this past weekend, when former President DONALD TRUMP, speaking at two separate campaign events, indicated his willingness to hand over the reins of much of his health policy portfolio to ROBERT F. KENNEDY JR., a longtime skeptic of vaccines and the pharmaceutical industry, a decision that could have significant impacts on the FDA.
• What was said: The first remark took place during an appearance by Trump on The Joe Rogan Experience podcast, where Trump said he told RFK he could “focus on health, you can do whatever you want.” Trump answered in the affirmative when JOE ROGAN asked him if he was “completely committed to have him [Kennedy] as part of your administration.” The next day, at a major campaign rally at Madison Square Garden in New York, Trump expanded on his remarks and articulated the scope of the portfolio he is prepared to offer Kennedy in his second administration. “I’m going to let him go wild on health. I’m going to let him go wild on the food. I’m going to let him go wild on medicines,” Trump said.
• This isn’t the first time that reports have indicated that Kennedy could have control of parts (or all) of Trump’s health policy portfolio. Earlier this year, when Kennedy abandoned his own campaign for President and threw his support behind Trump’s efforts, Kennedy told TUCKER CARLSON that his role in a future Trump administration would be to “help unravel the capture of the agencies by corrupt influence – in other words to drain the swamp.”
• As a member of Trump’s transition committee, Kennedy told Carlson he would have a role in “choosing the people who can run FDA, NIH and CDC in a way that restores public health.” Continued Kennedy: “I’ll bring in people to run those agencies like CALLEY MEANS and CASEY MEANS,” referring to siblings within the Make America Healthy Again (MAHA) movement. Calley Means told Carlson in an Aug. 2024 interview that he favors an executive order directing that the FDA “should stop being funded by pharma[ceutical companies],” referring to user fees, and also favors limits preventing FDA staff from leaving to work for pharmaceutical companies. He also favors making FDA an independent agency.
• Promised control of HHS and FDA: Kennedy offered additional clues about the scope of his control over Trump’s future health care portfolio in remarks made on Tuesday, Oct. 29 – one week before the Presidential election. “The key that I think I’m – you know, that President Trump has promised me is – is control of the public health agencies, which are HHS and its sub-agencies, CDC, FDA, NIH and a few others,” Kennedy said, according to CNN.

For the FDA, this level of control by Kennedy could be deeply concerning for a variety of reasons

• Perhaps the most obvious point to make is Kennedy’s longtime opposition to the way FDA regulates vaccines. During the Covid-19 pandemic, Kennedy was the Board Chair and Chief Litigation Counsel to Children’s Health Defense, a group that petitioned FDA to “revoke all [Emergency Use Authorizations] EUAs and refrain from approving and future EUA, NDA [New Drug Application] or BLA [Biologics License Application] for any Covid vaccine for all demographic groups.” The group also called on the FDA to allow the use of hydroxychloroquine and ivermectin for Covid-19 – two drugs found ineffective in treating persons infected with the SARS-CoV-2 virus. A review of Kennedy’s social media profile on ‘X’ (formerly Twitter) reveals hundreds of posts critical of FDA actions, with most focused on its review of vaccine products. And Kennedy has also discussed the topic of vaccine safety with Trump personally, which he revealed in a since-deleted post on social media.
• Children’s Health Defense has long stood in opposition to many FDA policies. Its website claims that vaccination is correlated with an increasing prevalence of autism and leads to developmental delays and other health conditions. It sued the FDA during the pandemic to obtain access to adverse event reporting documents related to Covid-19 vaccines (the case remains ongoing). In addition to the Citizen Petition referenced above, the group also sued FDA in an attempt to revoke FDA’s EUA for Pfizer and BioNTech’s Covid-19 vaccine. One would be hard-pressed to find even a single positive reaction to one of FDA’s decisions on its website. And “Reform Pharma,” an initiative of the group, has developed a 10-point plan to “restore healthcare integrity” which includes plans to “reform regulatory oversight agencies,” including the FDA, which it says currently serves as an extended arm of the pharmaceutical industry by way of its user fee funding mechanisms.
• Kennedy could exert significant control over FDA without actually working within or heading the agency. While the FDA is often thought of as an independent agency, it isn’t. The U.S. Department of Health and Human Services (HHS) is technically in control of FDA, with authority to review and control all its actions. While HHS rarely chooses to exert this control, it has happened on several notable occasions under both Democratic and Republican administrations. For example, in 2011, then-HHS Secretary KATHLEEN SEBELIUS publicly overruled FDA’s approval of an over-the-counter version of Plan B intended for use by young teenagers. During the Trump administration, HHS frequently stepped in on FDA-related policy decisions. In one notable example, HHS revoked FDA’s authority to regulate certain laboratory-developed tests (LDTs) intended for use for Covid-19 testing.
• During the Trump administration, HHS also frequently stepped in to handle regulatory matters that would traditionally have been the sole remit of the FDA. For example, HHS – not FDA – decided to reclassify dozens of medical devices that had been subject to FDA oversight, thereby exempting the devices from oversight under the agency’s premarket notification process and allowing them to be marketed without prior FDA review. HHS also decided to give the Office of the Assistant Secretary for Health (OASH) the authority to review certain LDTs on a voluntary basis. It rescinded FDA’s ability to collect OTC user fees on a temporary basis. It cancelled the FDA’s Unapproved Drugs Initiative.
• All of which is to say: Kennedy wouldn’t need to be FDA commissioner to hold tremendous influence over the FDA. As an executive within HHS, he could potentially overrule any FDA decision, including an approval. And looking back at actions by prior HHS Secretaries under the Obama and Trump administrations, he wouldn’t even be taking unprecedented action if he did.
• That then raises the question: Would Kennedy target the FDA for reforms if he is given control of HHS and FDA? Yes. In a post on the social media platform ‘X’ (formerly Twitter) on Oct. 25, he said that “FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. 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.”
• Preserve your records and pack your bags is about as clear a message of reform as we’ve heard in quite some time, although Kennedy doesn’t necessarily have an easy path to exerting control over FDA. For Kennedy to have control over FDA, in addition to Trump winning the election and upholding his promises to Kennedy, Kennedy would need to obtain Senate confirmation to hold many senior positions of actual authority. For example, the positions of HHS Secretary, FDA Commissioner and Assistant Secretary for Health all require Senate confirmation. While Republicans have an advantage in their bid to retake the Senate this election (they are defending fewer open seats), it’s unclear if elected officials would feel comfortable confirming Kennedy to a position of authority over medical product approvals and regulation.
• However, senior advisor positions and transition board positions do not require Senate confirmation and could still allow Kennedy to exert significant influence. During the first Trump administration, several senior advisors within the administration like SCOTT ATLAS and PETER NAVARRO were found to have meddled in FDA affairs, with both attempting to renew hydroxychloroquine’s EUA, according to a report by the House Select Subcommittee on the Covid-19 pandemic.
• If Kennedy does pursue a position requiring Senate confirmation, the confirmation process could prove difficult. Current FDA Commissioner ROBERT CALIFF was only narrowly confirmed (50-46) in February 2022 – despite Democratic Senate control and a previous turn as FDA commissioner that was generally unremarkable and scandal-free. In comparison, Kennedy would likely be more controversial and face strong opposition from many of the public health groups, patient groups and medical associations that traditionally have strong ties to legislators and their staff.
• If Kennedy is confirmed, other proposed sweeping reforms could mean his ability to influence FDA policy would be profound. The Trump administration is likely to pursue at least two major reforms to the federal bureaucracy if they win. According to Trump’s campaign website, he plans to restore an executive order “requiring that for every one new regulation, two old regulations currently on the books must be eliminated.” That would create an opportunity for significant streamlining of FDA’s regulatory framework, depending on the leader in charge. The second major reform is likely to be reinstating Schedule F, an October 2020 executive order that would have stripped job protections from many career Senior Executive Service government employees who typically work in a policymaking capacity. By making it easier for an executive to fire officials for perceived poor performance, Kennedy could theoretically hollow out the ranks of policy officials who don’t act in concert with his aims or ambitions. Althouigh the Biden administration has been taking steps to protect against Trump doing this as easily, these measures are unlikely to completely block him from taking action.
• But there are many things that could slow down Trump and Kennedy’s efforts to reform the FDA, including some longstanding laws, legal precedent and binding agreements. The process of removing a regulation is often as arduous as the process to create it in the first place. Many of the regulations the FDA does have are explicitly required by federal law, making it difficult to remove or alter them. Efforts to change longstanding policies could lead to lengthy legal challenges invoking the Administrative Procedure Act, frequently used to challenge both the creation and modification of regulatory policies. Any many actions are driven by FDA’s user fee programs, which are binding and agreed to by Congress.
• It’s worth emphasizing that Kennedy is hardly alone in his desire to reform parts of the federal bureaucracy, and his efforts could be greatly aided by others within a future Trump administration. One example is RUSSELL VOUGHT, the former head of the White House’s Office of Management and Budget (OMB) during the Trump administration. OMB acts as a sort of regulator of regulators, overseeing the federal bureaucracy, including regulations and major policies. Reporting by ProPublica discovered remarks made by Vought at several private speeches in which he said he wants to put career civil servants “in trauma” and have them viewed “as the villains” and deprived of funding. “We want the bureaucrats to be traumatically affected,” he said, according to the reporting. “When they wake up in the morning, we want them to not want to go to work because they are increasingly viewed as the villains. We want their funding to be shut down so that the EPA can’t do all of the rules against our energy industry because they have no bandwidth financially to do so.”

Keep a close eye on potential impacts to user fees and regulatory uncertainty

• The potential impact on FDA’s user fee programs and industry: The potential for Kennedy or other like-minded individuals to influence FDA policymaking should greatly concern the life sciences industry as well. The FDA receives a significant amount of funding from industry-paid “user fee” programs. These programs are initially negotiated between industry and FDA in accordance with federal law, and then the draft agreements are transmitted to Congress for review and passage. There are separate programs for pharmaceuticals (PDUFA), medical devices (MDUFA), generic drugs (GDUFA), biosimilar products (BsUFA) and nonprescription drugs (OMUFA), each reauthorized after five years. After the election, the OMUFA program is next up for reauthorization in September 2025, followed by the PDUFA, MDUFA, GDUFA and BsUFA programs in September 2027. While the OMUFA program reauthorization negotiations recently concluded, negotiations to reauthorize the other four programs are set to begin next year. The negotiations span many months, and progress could be greatly disrupted under certain conditions – such as an agency leader with an adversarial stance toward the life sciences industries.
• More than anything, the concern is regulatory uncertainty. Life sciences work with product development timelines measured in years, or even decades. Any disruption to the certainty of the regulatory environment could significantly and negatively affect the appetite for life sciences companies to make those long-term investments. For example, the FDA suddenly having fewer resources to put toward reviewing a product could result in delays. These delays, in turn, could mean a company needs to “carry” staff salaries for a longer period before it has a viable product it can sell. If the FDA increases its scrutiny of certain types of products (such as vaccines), that could also disincentivize investments in new products in the U.S.
• The impact to FDA’s workforce could also be significant. The FDA has long struggled to maintain its workforce, according to FDA’s Strategic Workforce Plan report. It pays less than private industry, its staff face heavy and challenging workloads, and retaining senior leaders is especially difficult since many are already past the age of retirement. A single disruptive leader (or disruptive influence) could damage workforce morale, resulting in a wave of retirements or resignations whose effects could be felt for many years. That should frighten the life sciences industry, since FDA’s ability to regulate is only as good as its ability to hire, train and retain talented and knowledgeable staff.
• The bottom line: For the FDA and the life sciences industry both, the stakes of this election could be significant, and recent developments leave them with little time to communicate the potential impact of certain personnel selections on important policies.

To contact the author of this analysis, please email Alexander Gaffney ( agaffney@agencyiq.com).

To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com).