The Trump Transition: How might MAGA and MAHA’s plans for FDA clash?

President-elect DONALD TRUMP has said he wants to let ROBERT KENNEDY JR. assume control of significant parts of his health policy portfolio. But unless he places restrictions on that control, parts of Trump’s Make America Great Again (MAGA) agenda may run headlong into Kennedy’s plans to Make America Healthy Again (MAHA). The FDA offers several notable flashpoints.

The first Trump administration’s oversight of the FDA had a generally predictable philosophy when it came to product oversight and approvals

• FDA approvals were deemed to be generally too slow, not encouraging of sufficient competition, were marked by inefficiencies, and did not permit individuals to exercise enough control over their care.

• The MAGA approach to regulation – accelerated significantly by both the Covid-19 pandemic and the 2017 passage of the FDA Reauthorization Act (FDARA) – resulted in some significant changes to the way FDA worked, including some changes which endure to this day. For example:

  o Approval speed was a priority. This resulted in some of the fastest approvals ever made by FDA during the pandemic, as well as a push by HHS for FDA to provide additional information about the length of drug reviews. An application of this principal that stood out was the administration’s Operation Warp Speed plan, which among other things involved a Coronavirus Treatment Acceleration Program (CTAP). That program was modeled on FDA’s existing Real-Time Oncology Review Program (RTOR); under both programs, the FDA begins review of a critical drug’s data package as soon the agency receives any portions of a sponsor’s submission, with extra support provided by FDA regulatory staff to speed a drug’s review and potential approval. Elements of CTAP and RTOR (which also began during the Trump administration) have expanded into other FDA pilot program such as its STAR and START pilot programs.

  o A Trump-era initiative pushed the FDA to leverage its user fee programs to promote drug competition and bring down prices. One of the most effective plans unveiled during the Trump administration was FDA’s Drug Competition Action Plan in 2017, which was intended to “encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process.” one of the central tenets of the plan was “improving the generic drug approval process” to make it more efficient; over time, such changes have been effected through the agency’s Generic Drug User Fee (GDUFA) program. FDA still maintains a webpage to highlight its progress against the Drug Competition Action Plan.

  o Enhanced user fees: The Prescription Drug User Fee (PDUFA) program is one of the FDA’s most important sources of funding and important drivers of reforms and efficiencies. During the first Trump administration, the passage of FDARA also reauthorized the PDUFA program and provided FDA with a significant boost in non-appropriated resources. According to a five-year financial report at the time of the bill’s passage, the program was expected to bring in $911.3 million in FY 2018, increasing to $1.13 billion by FY 2022.

  o Major legislative efforts: The first Trump administration fought for the passage of several landmark pieces of legislation. Perhaps the most notable was the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act – better known as the federal “Right-to-Try” Act. The law, modeled on similar state legislation, permits a drug company to make an investigational product available to a patient with a life-threatening disease or condition who has exhausted approved treatment options and is ineligible for a clinical trial for the drug. While the pathway is conceptually similar to FDA’s longstanding “Expanded Access” pathway, the RTT pathway includes a legal liability shield for participating companies, no requirement for the company to obtain review by an Institutional Review Board, the ability for the company to charge for access to the drug, and restrictions on the FDA’s ability to reference adverse events uncovered during the use of the RTT product during any subsequent product review for the purpose of approval. Trump continued to reference this legislation during his 2024 campaign.

But Kennedy’s plans for FDA apparently differ significantly from those of Trump’s first administration

• Speaking broadly, gone would be a focus on faster, more flexible, and better-resourced FDA reviews. In its place would be a focus on slower and more rigid reviews backed by fewer resources – several examples follow.
• Children’s Health Defense, the group for which Kennedy has served as chief litigation counsel, sued FDA in an attempt to revoke FDA’s EUA for Pfizer and BioNTech’s Covid-19 vaccine. The case, which featured Kennedy as a lead attorney, contended that FDA authorized Covid-19 vaccines too quickly.
• Eliminating user fees: Kennedy has said he intends to appoint people to high-level agency positions like “CALLEY MEANS and CASEY MEANS,” referring to medical entrepreneurs (and siblings) within the Make America Healthy Again (MAHA) movement. MAHA is both a political action committee and a plank on RFK’s campaign website, now transformed into a page congratulating President-elect Trump for his victory and explaning that “Our People-Powered Movement is more powerful than Wall Street, Big Tech, Big Pharma, Big Food and the War Machine.”
• Calley Means told media personality TUCKER CARLSON in an Aug. 2024 interview that he favors an executive order directing the FDA to “stop being funded by pharma[ceutical companies],” referring to user fees. “Reform Pharma,” an initiative of the Children’s Health Defense, has also developed a 10-point plan to “restore healthcare integrity,” with 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.
• The Right-to-Try legislation provided pharmaceutical companies an explicit liability shield against lawsuits and also allowed them to limit disclosure of certain adverse event reports to FDA outside of annual summary reports. By contrast, the MAHA movement seems focused on weakening liability protections for vaccine manufacturers. Rep. CHIP ROY (R-Texas) has introduced legislation supported by Children’s Health Defense that would remove federal liability protections for Covid-19 vaccines. And Kennedy said he wants FDA to make more adverse event information about vaccines available. “I’m going to make sure scientific safety studies and efficacy are out there, and people can make individual assessments about whether that product is going to be good for them,” he told NBC News.
• Kennedy came on board with Trump relatively late in this campaign cycle, and it’s been unclear what his role might be in the Trump administration. The public – and likely policy-makers within the Trump transition team – haven’t had much time to weigh these two visions of the FDA’s role against one another. On the one hand, the vision of the FDA during the first Trump administration represented a classically conservative approach to the agency and its role within a constrained federal government. In this view, the FDA should promote competition, reduce inefficiencies, maximize choice, and reduce the burden of government on taxpayers.
• In comparison, the second Trump administration seems poised to adopt some of the positions advanced by Kennedy and the Make America Healthy Again (MAHA) movement detailed above. The Means siblings, in particular, espouse policy changes aimed at steering “more healthcare dollars to incentivize metabolic habits at the root of disease,” to include actions to ban direct-to-consumer pharmaceutical advertising and “reform insane Ag subsidies” to trim or ban federal subsidy of tobacco and “ultra-processed food,” which Calley Means interprets to mean corn, soy, and wheat. These MAHA proposals, along with the Kennedy-MAHA proposal to eliminate the FDA’s user fee-based support, seemingly contradict some of the MAGA orthodoxies of the first Trump administration.

It’s unclear which vision – MAHA or MAGA – will ultimately win out

• For now, Trump has said he plans to let Kennedy “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.” He also said Kennedy would be empowered to “focus on health” in his administration.
• There are ample opportunities for clashes between MAGA and MAHA. Should FDA approve products more quickly to benefit patients (MAGA), or wait to accumulate the most evidence (MAHA)? Should companies be shielded from liability to encourage development, or intentionally exposed to it? Should FDA rely more heavily on user fees to reduce taxpayer obligations to fund the agency, or should those funds come from other sources (including taxpayers)? Should life sciences companies be offered a seat at the table in the interest of helping patients, or should regulators have more of an adversarial relationship with them? Should FDA be seen as promoting confidence about the medical products it regulates, or encouraging skepticism? Should the government regulate chemicals more loosely, or more stringently owing to their potential risks to human health?
• These are not small differences in philosophy, and there are potentially significant political ramifications to how they are answered. It’s possible that the MAHA movement and its goals could run into fierce opposition in Congress as soon as specific proposals are advanced; few groups have as much clout and organizing prowess in Congress as advocates for cancer patients and those with terminal or rare diseases. Nearly every member of Congress hears regularly from sick patients and their advocates. And while some of those patients might eagerly support reforms to the FDA, others may have concerns that those same reforms would deprive the FDA of the resources it needs to review much-anticipated products effectively or efficiently.
• Importantly, actions taken by Kennedy or his allies to eliminate to reduce industry-paid user fees could deprive the FDA of the resources it needs to conduct timely and efficient reviews of drugs, biologics and vaccines, thereby slowing approvals and reducing drug competition. That would be antithetical to some of the goals advanced in the first Trump administration. They may also stymie the efforts of Kennedy and MAHA in general. For example, cuts to FDA user fees (in addition to likely cuts from Congress to FDA’s budget) would reduce the agency’s ability to invest in the same adverse event monitoring systems for vaccines that Kennedy is so interested in leveraging.
• It’s also worth keeping a close eye on the potential for personnel-related conflicts. During the first Trump administration, advisors and influencers in Trump’s orbit would often fall out of favor after a relatively short period of time and be dismissed from the administration. And without an additional term as President to run for, President Trump may not feel a strong need to keep Kennedy around through his full term. Further, while Kennedy may be tasked with selecting leaders for HHS and FDA, he is also a former Democrat. Kennedy may find it challenging to select potential agency leaders who have not spoken unfavorably about Trump in the recent past.

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