The Trump Transition: The many ways RFK Jr. could disrupt FDA’s regulation of vaccines
ROBERT F. KENNEDY JR. is President-elect DONALD TRUMP’s intended nominee to be Secretary of the Department of Health and Human Services. While Kennedy has pledged not to take anyone’s vaccines away if he is confirmed as head of HHS, Kennedy would have almost unlimited authority to meddle in FDA’s regulatory processes for vaccines. Here, AgencyIQ provides an in-depth look at how Kennedy could make things more challenging for vaccine companies, even without withdrawing approved vaccines.
What Kennedy could do to FDA and vaccine manufacturers through his role at HHS
On Nov. 14, 2024, President-elect DONALD TRUMP announced his intent to nominate ROBERT F. KENNEDY JR. as his Secretary of the Department of Health and Human Services (HHS). The news, first reported by POLITICO, raises significant questions – and concerns – for the life sciences industry. As AgencyIQ has previously explained, Kennedy’s control of Trump’s health policy portfolio and HHS could be particularly disruptive for the FDA.
That’s because HHS is the parent agency of the FDA, so it can control what FDA does. While the FDA is often seen as acting independently, it is actually not an independent agency in the way that the Federal Trade Commission or Environmental Protection Agency are. Rather, it is an agency under HHS, alongside other major health agencies like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS). Because of this, all FDA actions may be reviewed, approved and even reversed by HHS leaders. In fact, some FDA functions are technically contained within HHS, such as its Office of General Counsel, which is a part of HHS’ Office of the General Counsel despite being administratively part of the FDA’s Office of the Commissioner.
Kennedy – a noted skeptic of vaccine safety who founded an advocacy group that has, at times advocated for FDA to remove vaccines from the market – could thus find himself with considerable authority over vaccines. AgencyIQ wanted to know what impact Kennedy could have on vaccines if he wanted to change how they are regulated? The following analysis reveals that there are many ways that Kennedy could affect vaccine regulation, even without revoking approvals for vaccines.
First, let’s talk about the most obvious mechanism: product approvals and withdrawals
Impact on existing product approvals and authorizations: If Kennedy wanted to – and he has said he doesn’t – he could order FDA to take action on existing vaccine approvals. While Kennedy wouldn’t be able to snap his fingers and have the FDA act immediately, he could direct the agency to start withdrawal proceedings against approved products – something Kennedy-aligned groups have previously petitioned for. Under the federal regulations (21 CFR 601.43) for biological products to include vaccines, FDA “may withdraw approval, following a hearing” for any of several reasons. These include that a postmarketing clinical study failed to show benefit, the applicant failed to perform required postmarketing studies, the postmarketing restrictions on the biologic are inadequate, or that other evidence shows the biologic to be unsafe or ineffective. This process is time-consuming and offers sponsors the opportunity for judicial review if they disagree with FDA’s ultimate decision to withdraw market approval for the product. However, Kennedy wouldn’t necessarily need to withdraw the entire vaccine. Instead, he could also order the withdrawal of specific indications of use, such as the vaccine’s approved use in pediatric populations, albeit after the statutory hearing process. This would likely involve a withdrawal of a specific supplemental approval.
Impact on existing product authorizations: Not all vaccine products are necessarily approved or licensed. Some are still marketed under existing emergency use authorizations (EUAs), which are granted based on public health emergencies based on standards for safety and efficacy which differ from standard approvals. Even if Kennedy doesn’t take action against approved vaccines, he could be interested in taking action against authorized vaccines based on his past actions. In May 2021, Kennedy co-signed a citizen petition on behalf of the organization he founded, Children’s Health Defense (CHD), that specifically requested FDA “revoke all EUAs and refrain from approving any future EUA, NDA or BLA [new drug and biologics license applications] for any COVID vaccine for all demographic groups because the current risks of serious adverse events or deaths outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the EUAs.” The existing, “highly effective” products referenced in the letter were hydroxychloroquine and ivermectin – products which FDA ultimately found were generally ineffective at treating Covid-19. In addition to the petition, CHD sued the FDA first seeking to revoke FDA’s EUA for Pfizer and BioNTech’s COVID-19 vaccine, and once again attempting to obtain access to adverse event reporting documents related to COVID-19 vaccines. The Informed Consent Action Network (ICAN), an anti-vaccine group founded by Kennedy campaign spokesperson DEL BIGTREE, has also petitioned FDA to take similar actions, alleging that “there was no legal emergency to justify emergency authorization” for a vaccine product in pediatric patients. Notably, several vaccine EUAs remain active at this time, and FDA is still making use of the EUA pathway as of late 2024.
Impact on new product approval decisions: HHS can overrule FDA’s decisions on new marketing applications. Perhaps the most famous example of the use of this authority occurred in 2011, when then-HHS Secretary KATHLEEN SEBELIUS publicly overruled FDA’s approval of an over-the-counter version of Plan B (Plan B One Step) intended for use by “women 16 years and younger” without a prescription. Then-FDA Commissioner MARGARET HAMBURG responded with a rare statement defending FDA’s decision to support approval, explaining that Sebelius had issued a memo “invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.” Hamburg then stated that Sebelius had directed her to issue a Complete Response Letter (CRL) – in effect, a denial requesting the application sponsor to obtain additional data – which FDA then did. Kennedy could thus potentially order FDA to issue CRLs to new vaccines, potentially citing a need to obtain additional data to support an expanded indication or a new use. This, again, is not merely a hypothetical concern. CHD has frequently said that FDA approvals aren’t based on sufficient data, and Trump’s pick to become FDA Commissioner, MARTY MAKARY, has said he was uncomfortable with FDA “clearing” certain vaccines based on no human outcomes data.
Advisory committees: Another potential pressure point Kennedy could press on is FDA’s advisory committee for vaccines: Its Vaccines and Related Biological Products Advisory Committee (VRBPAC). Advisory committees allow the FDA, at its discretion, to obtain outside advice regarding the approval of some new medical products. The meetings usually have a narrow focus that may not even include weighing in on product approval, and the decision to convene a meeting is generally left to the FDA product review team. The FDA, for its part, determines which committees it needs and who should sit on these committees. Under Kennedy, FDA could be directed to reconstitute the committee with different members, and Kennedy could also direct FDA to call VRBPAC meetings for each vaccine review (as FDA does for new opioid products). Kennedy could also call in temporary voting members of VRBPAC (i.e., non-permanent members brought on due to their salient expertise) who could potentially be vaccine safety skeptics.
But the FDA does far more than simply approve and withdraw products, and there is much more that Kennedy could do to affect vaccines
Product labeling: Kennedy could potentially order FDA to institute restrictive labeling on vaccine products, such as ones meant to highlight purported safety concerns or contraindications for specific populations (like children). This, again, is a topic for which anti-vaccine groups – including those supported by Kennedy – have weighed in. Both CHD and ICAN have contended that vaccine products are not properly labeled to warn patients and parents about the alleged risks of vaccines. For example, CHD stated that the FDA had used the EUA pathway to “mislabel drugs as vaccines, mislabel drugs that have not been thoroughly tested as safe and effective, mislabel drugs as permitted to be compelled without informed consent, and to mislabel drugs to children that result in mandates being issued concerning those children’s access to basic services, including medical and educational services.” ICAN previously petitioned FDA to revise its labeling to include information about the amount of specific adjuvants used in vaccines, such as aluminum, and also to include special statements regarding efficacy in package inserts. Kennedy himself has claimed that, “I just want to be sure every American knows the safety profile, the risk profile, and the efficacy of each vaccine. That’s it.” That information would almost certainly involve labeling changes.
Risk controls: While the FDA is often said to not regulate the practice of medicine, in fact it does have the power to place certain restrictions on how products are dispensed and prescribed. These restrictions are known as Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU). Kennedy could theoretically order FDA to instate REMS plans covering certain products or indications of those products – for example, requiring a specific consent document before allowing pediatric prescribing of a vaccine. Many REMS plans also include warnings (such as in the form of a Medication Guide) meant to alert users or prescribers to certain negative side effects or contraindications, which Kennedy could potentially influence. Federal regulations also require that such warnings be included in any advertising for the specific product, making this avenue potentially appealing for those hoping to influence public perception of vaccines.
Clinical trial regulations: For a vaccine to be approved, it must first be tested. Manufacturers initiate testing by submitting an application to the FDA known as an Investigational New Drug application (IND) detailing the preclinical evidence they have obtained to date, and detailing the protocol of how they plan to test the product in humans while safeguarding the safety of participants. While FDA allows most trials to proceed, it may also place a clinical hold on ongoing research, or prevent an IND from proceeding. Kennedy or his staff could potentially order FDA to place clinical holds on certain vaccine research or require that new INDs include significantly larger study populations. There are some indications of how regulatory standards could change. In prior exchanges with HHS, ICAN repeatedly insisted that vaccines, particularly those used in children, should be investigated using “long-term double-blind inert-placebo controlled trial[s]” prior to approval. The organization further argued: “The fact that HHS does not and apparently will not require pharmaceutical companies to use a placebo control in pediatric vaccine clinical trials evidences HHS’s lack of confidence in the safety profile of these products. If HHS had confidence in their safety profiles, it would require that vaccine clinical trials – as is typical for drug clinical trials – include a placebo-control group.” For vaccines approved to date, ICAN states that the only way to answer many questions on vaccine safety is to conduct a large, long-term study “comparing the rate of all adverse events between vaccinated children and completely unvaccinated children.”
Additional studies: At the time a vaccine is approved, FDA may still have lingering concerns about the product’s safety or efficacy, such as whether a rare side effect observed in a trial may be more common than currently known, or understanding how a vaccine works in a specific population. To answer these questions without holding up approval of the entire product, FDA may require the vaccine’s manufacturer to conduct post-marketing studies, known as Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs). Kennedy could direct FDA to institute more of these required studies as a condition of approval. In addition, failure to complete these studies by agreed-upon timelines can also constitute a valid reason for withdrawal of a drug’s approval, thereby raising the stakes (and costs) for companies to conduct that testing. There are at least 45 vaccine applications (including supplemental applications) subject to PMRs and PMCs, which also include pediatric study requirements under the Pediatric Research Equity Act (PREA).
Adverse event monitoring: FDA maintains many different methods of monitoring the side effects of vaccines, including its Vaccine Adverse Event Reporting System (VAERS), mandatory reporting of adverse events by vaccine manufacturers, its Sentinel active surveillance system, and more. As HHS Secretary, Kennedy and his staff will have access to these datasets and could potentially use them to raise concerns about specific adverse events or safety signals associated with vaccines. Previously, Kennedy and his groups needed to submit Freedom of Information Act (FOIA) requests to access the same data. Now, though, Kennedy will have unfettered access – and could also invite others to obtain access as well.
Guidance: The FDA doesn’t approve products in a vacuum. Rather, it typically publishes guidance documents that companies use when developing vaccines and other medical products. Those guidance documents may contain advice about FDA’s preferred endpoints for clinical trials, the number of patients to be enrolled, adverse events to monitor for, the duration of the trial, and even the target efficacy needed to be achieved to substantiate approval or authorization. FDA has published many guidance documents related to adverse events, and it’s possible Kennedy could direct the FDA to withdraw certain guidance documents, modify them, or even publish new guidance. During the first Trump administration, FDA guidance was prevented from being published by HHS, and even withdrawn in one instance. Kennedy could thus use guidance documents to direct vaccine manufacturers to conduct more stringent clinical trials or take other actions favored by anti-vaccine advocates.
FDA review staff: While many FDA staff are “career” government officials, and therefore subject to civil service protections, Trump previously proposed to modify those protections for some senior staff under a policy known as Schedule F. As initially published during the first Trump administration, Schedule F would apply to officials in a “policy-determining, policy-making, or policy-advocating” position, making it easier to fire them for performance-related issues. Trump has proposed to bring back Schedule F during his second administration. In theory, this could allow Kennedy to identify certain FDA staff involved in vaccine policymaking and seek to terminate them for cause, although this would likely be logistically difficult and require FDA to first identify all such officials in policymaking roles. FDA’s Center for Biologics Evaluation and Research (CBER), which regulates vaccines, might be a prime target for this sort of review.
Citizen Petitions and lawsuits: As noted previously, FDA receives many Citizen Petitions from law firms, advocacy organizations, concerned citizens and more. Many of these petitions are reviewed not just by FDA’s reviewers, but also by its legal and policy staff. Since FDA legal staff technically work for HHS, Kennedy could direct FDA to respond favorably to certain petitions asking for FDA to make changes related to specific vaccines. And Kennedy could do the same for lawsuits against the FDA, directing government attorneys to acquiesce to specific requests related to vaccines. AARON SIRI of the law firm Siri & Glimstad – a frequent petitioner and litigant against FDA on vaccine-related issues – is reportedly on Kennedy’s short-list for the position of HHS General Counsel.
FDA authorities: As noted above, many of FDA’s statutory authorities and requirements are technically bestowed upon “the Secretary” of HHS by Congress – not the FDA. Kennedy could thus revoke or reassert some of those authorities, thereby removing FDA’s ability to oversee certain regulatory aspects of vaccines and instead maintain direct oversight and control. As noted previously by AgencyIQ, this sort of behavior happened frequently during the first Trump administration. For example, HHS revoked FDA’s authority to regulate certain laboratory-developed tests (LDTs) intended for use for COVID-19 testing and opted to give the Office of the Assistant Secretary for Health (OASH) the authority to review some LDTs on a voluntary basis. Further, it was HHS—not FDA—that decided to reclassify dozens of medical devices that had been subject to the agency’s oversight, thereby exempting the devices from FDA’s premarket notification process and allowing them to be marketed without prior FDA review.
User fees: As AgencyIQ has explained, Kennedy and Kennedy-aligned groups are no fan of the FDA’s user fee programs, which provide extensive funding for the agency. As HHS Secretary, Kennedy could direct that FDA not negotiate with industry to reauthorize several of FDA’s user fee programs, which are set to expire by the end of Trump’s term in office (September 2027). The negotiation process for the Prescription Drug User Fee Program (PDUFA) is set to begin in summer 2025, shortly after a new HHS Secretary is likely to have been sworn into office. Any attempt to eliminate or diminish the PDUFA program would also directly affect vaccine reviews. At present, vaccine developers benefit from predictable review timelines established by PDUFA, and the negotiated “ commitment letter” also includes funding in support of FDA research and programs related to vaccines. For example, under the most recent iteration of PDUFA, FDA committed to assessing “the performance of an algorithm using electronic health record (EHR) and claims-linked healthcare data for a pregnancy-related outcome, or composite of outcomes (e.g., spontaneous abortion, stillbirth, congenital malformations), after use of vaccines in pregnant women.” Another commitment was to develop “a method to use a double negative control adjustment to reduce unmeasured confounding in studying effectiveness of vaccines.” HHS, notably, has recently intervened in user fee programs. In 2021, DHHS rescinded FDA’s ability to collect user fees for certain nonprescription (over-the-counter) drugs on a temporary basis after industry raised concerns about whether user fee requirements should apply to distillers of hand sanitizer during the pandemic.
What’s next?
The degree to which Kennedy will be willing, or able, to utilize these tools isn’t clear. While Kennedy has already said he isn’t going to “take away anybody’s vaccines,” his lengthy track record on policies indicates that he is very much in favor of doing exactly that. And as our analysis above confirms, there are many actions that Kennedy could take that don’t involve taking away a vaccine, but which would involve making it considerably more onerous and costly to bring new vaccines to market.
Kennedy could also be curtailed or slowed by some of the same legislation and administrative actions typically used by industry to decelerate or defeat pro-regulatory policies, such as those under the Biden administration. If Kennedy does change existing regulatory policies against vaccine manufacturers, companies might choose to sue HHS and Kennedy under the auspices of the Administrative Procedure Act, which prohibits regulatory actions that are deemed arbitrary and capricious. At the very least, Kennedy would need to comply with extensive due process regulations, and further litigation could extend the timeline for any adverse actions. Further, since the recent Supreme Court decision of Loper Bright v. Raimondo, which overturned the longstanding Chevron deference standard, justices are more empowered than ever to review administrative decision-making, including decisions like vaccine withdrawals.
It would be difficult for Kennedy to do any of this by himself, and so something industry will likely be watching closely is the extent to which he’ll hire some of his existing confidants and people from vaccine-skeptical networks, like CHD, ICAN and affiliated law firms like Siri & Glimstad. As POLITICO has reported, Kennedy’s “MAHA transition team” already includes several of those figures, including KIM HAINE (President of CHD’s Hawaii chapter), Del Bigtree (Executive Director, ICAN) and Aaron Siri.
One irony will be that Kennedy will find it difficult to support extra FDA vigilance into vaccines if the agency’s budget is cut by Congress or if he disrupts the PDUFA program. FDA provides significant funding to the VAERS and Sentinel programs, and budget cuts and austerity measures (like the Department of Government Efficiency) could imperil both efforts – or at least force them to scale back.
Much will also depend on the working relationship between Kennedy and Marty Makary, Trump’s intended nominee to serve as FDA Commissioner. Many FDA commissioners have chafed against HHS secretaries who tried to intervene in the FDA’s work as an independent agency. Makary could, if formally nominated and confirmed, come into conflict with either Kennedy, HHS leadership, or FDA’s own staff. The personal dynamics between Makary and HHS leadership will be essential in determining the leeway FDA has to regulate. While Makary has shown that he’s pro-vaccine, he has also been a frequent critic of FDA’s authorization of vaccines during the Covid-19 pandemic, previously stating that FDA’s role had devolved into being “the marketing department for Pfizer and Moderna.” Makary might therefore not push back as hard against some vaccine-related decisions made by Kennedy as past commissioners might have. [ Read AgencyIQ’s analysis of what Commissioner Marty Makary would mean for FDA.]
To contact the author of this item, please email Alexander Gaffney ( agaffney@agencyiq.com) and Rachel Coe ( rcoe@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).
To read other articles in our Trump Transition series, please see our Table of Contents piece here.