Dr. Marty Makary has resigned as commissioner of the Food and Drug Administration, ending a tenure of just over one year that was marked by internal upheaval, conflicts with Health Secretary Robert F. Kennedy Jr., and criticism from key Republican constituencies including anti-abortion groups and vaping industry executives.
Makary, a surgeon and health researcher who rose to prominence among Republicans as an outspoken critic of COVID-19 health measures during the pandemic, struggled to manage the FDA's bureaucracy after mass layoffs, leadership upheavals, and a series of controversies in which agency scientific principles appeared overridden by political interests. President Donald Trump told reporters outside the White House that Makary is "a great doctor" who was "having some difficulty."
What the Left Is Saying
Senate Democrats have questioned the legality of several of Makary's initiatives, including a program offering drugmakers expedited reviews for innovative medicines. Critics on the left argued his tenure prioritized political considerations over scientific integrity. A dozen former FDA commissioners issued what they called a scathing denunciation of planned vaccine policy changes, warning they would "undermine the public interest" and damage vaccine development. The concern among Democrats was that Makary's handpicked deputy, Dr. Vinay Prasad, repeatedly overruled career staff on vaccine decisions, including initially refusing to consider Moderna's mRNA flu shot in February before being forced to reverse course. Specialty drugmakers studying therapies for rare or hard-to-treat diseases reported receiving rejection letters or requests for additional studies for drugs previously approved by FDA staff.
What the Right Is Saying
Trump and his allies framed Makary's resignation as amicable, with the president saying Tuesday that Makary "was having some difficulty" but would "go on and do well." Vaping industry executives had told Trump that Makary was blocking approval of their products, including new flavored e-cigarettes seen as crucial to the industry's survival. In recent weeks, anti-abortion groups accused Makary of slow-walking an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target for conservative activists. Supporters argued that Makary pursued aggressive efforts to cut regulatory red tape at the FDA, including dropping certain study requirements, incorporating artificial intelligence into drug evaluations, and offering expedited reviews to medicines supporting "national interests."
What the Numbers Show
Makary's tenure lasted just over one year leading the agency that regulates billions of dollars in consumer goods and medicines. In the FDA's drug center—the agency's largest division—six people served as director over the course of one year, illustrating the leadership instability during Makary's term. His initial pick for drug center director, Dr. George Tidmarsh, was forced to resign after allegations he used his FDA position to pursue a personal vendetta against a former business partner. His replacement, Dr. Rick Pazdur, announced retirement after just three weeks on the job following clashes with Makary over drug review issues. Makary promoted more than half a dozen initiatives aimed at speeding up or streamlining FDA drug reviews.
The Bottom Line
With Makary's departure, the fate of many of his initiatives remains uncertain. Most programs he introduced have not gone through federal rulemaking required to permanently establish them and could be easily overturned by successors. Kyle Diamantas, the agency's chief for foods, is expected to take over as acting commissioner; Diamantas is an attorney with personal ties to Donald Trump Jr. A permanent replacement will need nomination by Trump and confirmation by a majority Senate vote. The resignation raises questions about the future direction of FDA regulation under continued pressure from both the vaping industry and anti-abortion advocates, while career staff attrition that saw virtually all senior officials resign, retire, or be forced out leaves significant institutional knowledge gaps.