A Path to Stability at FDA?

In September 2025 at the University of Utah S.J. Quinney College of Law, I presented a paper titled “FDA in 2050: Best- and Worst-Case Scenarios,” which was recently published in the Utah Law Review. As it turns out, it would have been hard enough to predict what has happened at FDA in just the past year. 

By May 2026, Marty Makary had resigned as FDA Commissioner after a turbulent tenure marked by staffing shortages, political interference, and industry uncertainty. Soon after Makary’s resignation, FDA’s Interim Commissioner Kyle Diamantas took steps to reverse course from Makary’s habit of bypassing traditional administrative rulemaking and instead announcing FDA policy changes through informal channels like academic journal articles, press releases, and podcasts.

Yet more is needed to provide a semblance of stability for key stakeholders, including regulated industries that depend on an agile, fully functional agency to provide consistent, reliable guidance and regulatory determinations. To the contrary, the Interim Commissioner is an attorney who has limited experience in the types of products regulated by FDA outside representation of industry stakeholders in food and tobacco and a short stint as head of FDA’s Human Foods Program. 

Meanwhile, the turmoil has continued. Foodborne illness is up significantly as compared to last year, and a Cyclospora outbreak over the summer sickened thousands. Taylor Farms, the company whose lettuce contributed to the outbreak, seemingly exerted its political leverage as a Trump donor to compel a walk back from FDA. In July, an FDA advisory committee recommended several peptides for compounding despite limited evidence of safety and efficacy. Secretary of Health and Human Services Robert F. Kennedy Jr.  had pushed the agency to loosen restrictions a few weeks earlier.

On Aug. 18, President Trump appointed physician and White House aide Dr. Heidi Overton to be FDA Commissioner. The U.S. Senate hearing seems likely to occur after the 2026 midterm elections, though Bill Cassidy, outgoing U.S. Senator from Louisiana and current chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP), threw cold water on her candidacy soon after the announcement. Overton, who served as chief policy officer of the America First Policy Institute prior to her White House role, was involved in the recent Executive Order on childhood vaccination.

Given what has happened at FDA in the past few months, what would stability even look like? What goals should the next FDA Commissioner try to advance?

Addressing Public and Industry Confidence

Concerns about politicization have always been part and parcel of an executive agency whose Commissioner is appointed by the President. In the past, FDA leaders have leaned on the institutional knowledge and expertise of senior leadership, scientists, and staff to continue ongoing efforts without missing a beat. Yet Makary’s regime began with reductions in force by the Elon Musk-led Department of Government Efficiency (DOGE) and other senior level departures, which considerably depleted institutional knowledge and capacity. 

The response was to “do less with less.” Drug product reviews were further accelerated beyond abbreviated timelinesnegotiated as part of the Prescription Drug User Fee Act (PDUFA) in 1992. The Commissioner’s National Priority Voucher (CNPV) pilot program was a clear example. The program bypassed traditional rulemaking processes while awarding vouchers in an inconsistent, often politicized, manner. The goal was simple: speed approval time to then-unheard of times of 1-2 months. Staff were reportedly told to “skip” steps in the regulatory process. A new FDA Commissioner must communicate to industry, physicians, patients, and other stakeholders that stability is on the horizon; a wind-down of the CNPV program and other Makary-era initiatives may be in order.

Addressing FDA’s Workforce 

FDA currently faces a staffing crisis, driven by layoffs of employees who worked in key areas of food and drug regulation, including drug review and safety surveillance. Until and unless the agency can repopulate its workforce with qualified experts, FDA will be ineffective in doing its job. 

Even though FDA has special hiring authorities to offer competitive pay, re-hiring of former FDA personnel will require reassurance that jobs will not be arbitrarily terminated by entities like DOGE who do not understand how the FDA works. This requires re-commitment to public service and re-alignment with the agency’s longstanding mission to protect public health. An apolitical nominee could have been a breath of fresh air in that regard. So, too, might any assurance that political interference by the Department of Health and Human Services or other political officials will be minimized moving forward. Recent trends suggest that neither is forthcoming.

Prioritizing Public Health Over Politics

At its core, FDA is a public health agency. Its public health role may not appear to be as central to its work as compared to agencies like the Centers for Disease Control and Prevention (CDC), but it oversees several areas that directly impact the public’s health, including food, drug, and tobacco regulation. Earlier this year, when electronic cigarette manufacturers, disappointed by FDA’s reluctance to approve their products, were able to persuade the White House to push for clearance, the public health mission was undermined. FDA’s response was to greenlight those approvals, prompting the resignation of then-Commissioner Makary. And when political donors respond to news of an outbreak of Cyclospora in its food products with complaints to the White House, the public health mission was undermined. 

FDA’s role is to provide a regulatory framework that protects the public from foreseeable harms. The public needs a clear reminder that FDA is on their side.