Dr. Marty Makary resigned Tuesday as commissioner of the U.S. Food and Drug Administration, pushed out by Health Secretary Robert F. Kennedy Jr. after months of anger from pharmaceutical CEOs, anti-abortion activists and vaping lobbyists who are allies of President Donald Trump. Kennedy made the decision to remove Makary and the White House signed off, an administration official told the Associated Press.
Trump, speaking to reporters, described Makary as “a great doctor” who “was having some difficulty.” Makary himself, in a resignation text message Trump posted on social media, said he had “announced 50 major FDA reforms” and noted that Joe Biden’s FDA had none. Trump named Kyle Diamantas, the agency’s foods chief and an attorney with personal ties to Donald Trump Jr., as acting commissioner.
Makary, a surgeon and former Fox News regular who criticized pandemic public health measures, struggled to manage the agency after mass layoffs and leadership upheavals. Virtually all of the FDA’s senior career officials resigned, retired, or were forced out during his tenure, fueling leaks and negative stories about low morale and dysfunction.
The most intense controversies involved Makary’s deputy, Dr. Vinay Prasad. In an internal memo last November, Prasad asserted that the FDA had linked COVID-19 shots to the deaths of 10 children—a claim for which he published no evidence, the AP reported. Prasad used the assertion to justify a planned overhaul of vaccine approvals, drawing a scathing denunciation from a dozen former FDA commissioners who warned it would “undermine the public interest.” Prasad also initially refused to consider Moderna’s mRNA flu vaccine, forcing the agency to reverse itself after Moderna threatened to formally challenge the decision. Prasad was pushed out of the agency twice in less than a year.
The FDA’s drug-review center saw a revolving door of leadership, with six people serving as director over the course of one year. Makary’s first pick, Dr. George Tidmarsh, was forced to resign over allegations that he used his post to pursue a personal vendetta against a former business partner. His successor, longtime FDA cancer specialist Dr. Rick Pazdur, announced his retirement after just three weeks, following clashes with Makary over drug reviews.
Makary also faced pressure from anti-abortion groups, who accused him of slow-walking an internal review of the abortion pill mifepristone. “We look forward to a new FDA commissioner who will put an end to the mail-order abortion drug regime,” Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said. Vaping executives complained that Makary was blocking flavored e-cigarette approvals; last week the FDA abruptly authorized the first fruit-flavored e-cigarettes, but the move came too late to keep him in the job.
Makary’s departure leaves the fate of his initiatives uncertain. Most of his programs, including expedited drug reviews for medicines that support “national interests,” had not undergone federal rulemaking, and some Democrats in Congress have questioned their legality.