The Trump Transition: The future regulatory philosophy of the FDA is still a mystery

With just one month to go before President-elect DONALD TRUMP takes office, there are signs that senior officials within the incoming administration harbor deep disagreements regarding the role of the FDA in the health care ecosystem. These disagreements could soon result in major fights over the future, and direction, of the agency.

Background

• Most presidential administrations have an overarching philosophy of governance that unifies and explains their regulatory decision making. Recent Democratic presidents, for example, have generally supported regulatory agencies, seeing a role for regulation in holding companies accountable for their behavior and protecting public health and wellbeing. Republican presidents, meanwhile, have generally argued that regulation can be onerous and can serve as a tax on growth.
• During his first term in office, President-elect DONALD TRUMP mostly – though not exclusively – enacted a regulatory agenda that sought to decrease federal regulations and diminish the authority of regulatory agencies. One of the ways he did this was through the repeated use of executive orders, a declaration that carries the force of law and doesn’t require Congressional signoff. For example, he issued an executive order requiring federal agencies to eliminate two regulations for each new regulation they proposed and to designate regulatory reform officers responsible for helping to reduce regulations. Another executive order would have eliminated the job protections of more government employees in charge of regulatory policy. One notable regulation released by the Department of Health and Human Services (HHS), the parent department of the FDA, would have required that all regulations be reviewed at least once every 10 years.
• But Trump – like most U.S. presidents – was also keen to use federal regulations to enact his administration’s agenda. With respect to FDA-related policy, Trump also released an executive order allowing specific types of prescription drug products to be imported in a bid to lower drug prices. FDA’s Drug Competition Action Plan extensively used regulatory actions to encourage the approval of generic drugs and address drug pricing.
• In general, most presidential administrations are relatively consistent in their regulatory philosophy over their course. With rare exception, a president who runs on a deregulatory agenda won’t be looking to dramatically increase regulation by certain agencies.

A regulatory debate: Regulate less, or regulate more – or both?

• As Trump readies his second administration, there’s emerging evidence of a disparate philosophical approach, without a consistent vision for how the FDA should regulate the industries it oversees. Incoming officials, ranging from President-elect Trump to his top intended health officials and top regulatory reformers, have all shown differing takes on the role FDA should play in the new administration.
• Let’s start by looking at what Trump himself has said. Trump’s stated vision for the agency is one of reform. In a statement announcing his intended nomination of MARTY MAKARY as FDA Commissioner, Trump said the FDA has “lost the trust of Americans, and has lost sight of its primary goal as a regulator.” Makary’s job, if confirmed by the Senate, would be to “course-correct and refocus” the FDA. Part of that focus would be to “properly evaluate harmful chemicals” in the food supply and “drugs and biologics being given to our nation’s youth.” Trump wrote that his vision is for Makary to “restore FDA to the gold standard of scientific research, and cut the bureaucratic red tape at the Agency to make sure Americans get the medical cures and treatments they deserve.”
• Notably, Trump’s statement points to two potentially opposing regulatory philosophies. On one hand, Trump is calling for Makary to cut through perceived red tape where the agency is too slow to review or regulate some products. This isn’t a new stance: In Trump’s first administration, he fought for the passage of the Right to Try Act, meant to be a pathway for patients to obtain certain investigational products without the intervention of the FDA. Trump also pushed FDA to authorize vaccines for Covid-19 more quickly, and blamed FDA and the “medical deep state” for not authorizing Pfizer and BioNTech’s Covid-19 vaccine prior to the election – for what he believed were political reasons. Trump’s HHS also released a notice in January 2021 indicating that FDA was not meeting a legal obligation to review all new drugs within 180 days, and issued a regulation (withdrawn by the Biden administration) to bypass the typical Medicare program coverage process for FDA-designated breakthrough devices.
• But on the other hand, Trump’s statement highlights other areas likely to be more stringently regulated, with more bureaucratic oversight. Manufacturers of food chemicals are likely to be most affected, with Trump pledging to “properly evaluate harmful chemicals” currently permitted in food products offered for sale. However, Trump’s statement indicates that he also expects Makary to “properly evaluate […] drugs and biologics being given to our nation’s youth, so that we can finally address the childhood chronic disease epidemic.” This could indicate that the FDA may be asked to scrutinize pediatric indications of some drugs and biologics, or that companies could be asked to more stringently study their products after approval as part of pediatric study requirements like the Pediatric Research Equity Act (PREA).
• Members of Trump’s proposed incoming administration have also indicated potentially contradictory approaches to FDA regulation. Even as Trump has said he wants Makary to increase the evaluation of certain products, VIVEK RAMASWAMY, one of the co-leaders of his Department of Government Efficiency (DOGE) advisory panel, has said he believes FDA “erects unnecessary barriers to innovation,” has “disregard for the impact of its daily decisions on the cost of new innovation,” and should potentially not even exist at all. Ramaswamy and DOGE co-lead ELON MUSK are also hoping to identify hundreds of billions of dollars in cuts to federal agencies, as well as a major reduction in federal regulation – changes that could potentially hamstring the ability of FDA to enact some of the same changes that Trump and others have called for.
• Kennedy is perhaps the incoming administration’s most ardent supporter of enhanced regulatory action by the FDA. He has long called for additional oversight by FDA of existing medical products, especially vaccines. [See AgencyIQ’s analysis of the many ways RFK Jr. could disrupt FDA’s regulation of vaccines, and how he is likely to influence the FDA.] However, he has also called for the agency to reduce or eliminate its regulation of other product types. In a statement on the social media platform X, Kennedy wrote: “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.” But Kennedy has also made clear that other divisions of FDA will “have to go,” as he believes they aren’t regulating products enough to protect the public.
• As AgencyIQ has explained, Kennedy-aligned groups and individuals have also pointed to FDA’s user fee programs as evidence of “conflicts of interest” at the FDA that give the pharmaceutical industry too much power over the agency. Kennedy has said Trump has instructed him to root “the corruption and the conflicts out of the regulatory agencies” and to “return the agencies to the gold standard empirically based, evidence-based science and medicine that they were once famous for.” That could include the modification, re-framing, or potentially even elimination of FDA’s user fee programs, which currently heavily fund many review activities at the FDA. Disruptions to those programs would significantly impact the review of most drugs, medical devices, biologics, generic drugs, biosimilars, and nonprescription drug products.
• While Makary doesn’t appear to have made any public statements since he was announced as Trump’s intended nominee, his past statements indicate that he has believed FDA has moved both too slowly and too quickly to regulate certain products, and in particular vaccines. In December 2020, Makary authored an article chiding the FDA for being too slow to authorize the initial Covid-19 vaccines, saying they were “wasting precious time” and not working hard enough to get the vaccine to approval. “The FDA has been too bureaucratic, taking too much time,” Makary told Fox News. In 2022, however, Makary wrote on social media that he was uncomfortable with FDA approving updated versions of mRNA vaccines for Covid-19 based on no human clinical data available to the public, and later said FDA should have rejected the data. [Read AgencyIQ’s analysis of Marty Makary’s past statements here.]
• Any regulatory actions by the FDA are likely to be influenced as well by executive orders or presidential memoranda that Trump has promised to enact early in his administration. These avenues of policymaking allow for speedier reforms than seeking Congressional cooperation on legislative overhauls, but also have some more targeted impact than legislative reforms. On the 2024 campaign trail, Trump stated he would cut 10 existing regulations for every new rule promulgated. If implemented as stated, this strategy would be drastic but not entirely unprecedented. During Trump’s previous term in office, the administration reported that “Between FY 2017 and FY 2019, the Trump Administration has cut nearly eight regulations for every new, significant regulation.” Such an approach could be difficult for the FDA to implement long-term. While there are many regulations on the books covering specific standards (FDA’s now-eliminated standard of identity for frozen cherry pie comes to mind), there is a finite number of these and other regulations that can easily be eliminated without disrupting standards intended to protect consumers or aid in the development of new products. Trump has also promised to reinstate his Executive Order creating Schedule F of the civil service, which would make it easier for the administration to fire certain federal employees. Finally, Trump is likely to enact a federal hiring freeze, as he did early in his first administration. These actions could make it difficult for FDA to conduct policymaking activities supported by some of his top officials.

Analysis

• Senior officials within the Trump administration, including DONALD TRUMP himself, can’t seem to agree on the regulatory philosophy of the FDA, with conflicting statements from Trump’s future senior administrators making it hard to chart the overall regulatory course for the FDA during the next four years. In general, Trump believes that FDA – like other regulatory agencies – is too bureaucratic, slow to act, and inefficient. This view is especially shared by Ramaswamy, a former biotechnology executive. But it is also clear that Trump has warmed to the views of Makary, Kennedy and other that for some areas of public health, the agency doesn’t regulate stringently enough. These include regulation of food chemicals and vaccines, as Trump indicated in an interview with TIME Magazine in which he said he could “want to see the numbers” on scientifically unsupported connections between vaccines and autism.
• These views of regulation are likely to collide in some notable ways during the next administration. If Trump and the DOGE initiative are successful in severely cutting the federal budget, reducing the size of the federal bureaucracy, and eliminating many federal regulations, that could make it difficult for Kennedy and Makary to address their goals for the FDA. As AgencyIQ has previously noted, the goals of “Make America Great Again” (MAGA) and “Make American Healthy Again” (MAHA) may be temporarily aligned, but they are generally seeking different things.
• Many governing philosophies aren’t static, but rather change throughout an administration in response to political pressure, scandals and emergencies. For example, Trump largely ignored the FDA during the early part of his administration, until the Covid-19 pandemic emerged and became a major focus for Trump and the country at large. This time around, the Trump administration may take some time to figure out what it wants to do with the agency and then leverage its authorities. As leaders change within the administration, so might its regulatory philosophy adapt. Leaders of most agencies turned over at least once during the first Trump administration, with some leaders taking markedly different approaches to running their agencies.
• AgencyIQ will also be watching how congressional leaders seek to align with, or influence, debates over the future of the FDA. As previously noted by AgencyIQ, many of the members of Congress most familiar with the FDA have recently retired or lost their bids for reelection (especially in the House). The health committees of both the House and Senate will also see new leaders. Rep. BRETT GUTHRIE (R-Ky.) was recently named chair of the full Energy & Commerce (E&C) committee, and an upcoming process will decide which Republican member will assume control of the E&C subcommittee on Health. In the Senate, meanwhile, Sen. BILL CASSIDY (R-La.) is the incoming chair of the Health, Education, Labor and Pensions (HELP) committee after Republicans retook the Senate in this year’s elections. With so many new legislators unfamiliar with the FDA, there will likely be fewer voices available to speak up in defense of FDA’s existing ways of doing business. However, we’re also expecting some members to weigh in nonetheless on the governing philosophy of the FDA, with some asking for more, and some for fewer, regulatory activities.

To contact the author of this piece, please email Alexander Gaffney ( agaffney@agencyiq.com)
To contract the editor of this piece, please email Kari Oakes ( koakes@agencyiq.com)

To read other articles in our Trump Transition series, please see our Table of Contents piece here.