WASHINGTON (AP) 鈥� The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after that drew from health industry executives, anti-abortion activists, vaping lobbyists and other allies of President Donald Trump.
He steps down after just over a year leading the powerful health regulatory agency, according to a White House official who was not authorized to speak before an announcement expected Tuesday and insisted on anonymity.
Kyle Diamantas, the agency鈥檚 chief for foods, will take over as acting commissioner, the official said. Diamantas is an attorney with personal ties to Donald Trump Jr.
A surgeon and health researcher, Makary came to prominence among Republicans as an outspoken critic of COVID-19 health measures during the pandemic when he frequently appeared on Fox 太子探花.
But he the FDA鈥檚 bureaucracy and failed to win the confidence of its staff after mass layoffs, leadership changes and a series of controversies in which the agency鈥檚 by political interests, including those of Health Secretary Robert F. Kennedy Jr.
The FDA commissioner, as the leader of an agency that regulates billions of dollars in consumer goods and medicines, is often required to juggle competing priorities that straddle science and politics.
Makary faced a unique challenge in balancing calls by Trump and other Republicans to cut red tape at the FDA, while also tending to Kennedy鈥檚 interest in scrutinizing of , drugs and food additives.
Virtually all of FDA鈥檚 senior career officials resigned, retired or were forced out in the first year of the second-term Trump administration, leading to a steady stream of leaks and negative stories in the media cataloging low morale, dysfunction and frustration among staff.
Makary鈥檚 handpicked deputy, Dr. Vinay Prasad, was in less than a year for running afoul of specialty drugmakers and groups for patients with rare diseases. Makary appeared poised to weather the controversy, despite an ongoing pressure campaign calling on Trump to fire him.
Recent months brought fresh criticisms from other interest groups that the White House considers key to Republican chances in November elections.
Anti-abortion groups have criticized Makary for allegedly slow-walking an internal review of , which has been on the market for 25 years but remains a target for conservative activists.
Vaping executives told Trump that Makary was blocking approval of their products, including seen as crucial to the industry’s survival.
Last week, the agency abruptly changed course on vaping: authorizing the first fruit-flavored products and issuing guidelines that loosened marketing for major manufacturers. But it wasn’t enough to keep Makary in the job.
A permanent replacement for FDA commissioner will need to be nominated by Trump and confirmed by a majority vote in the Senate.
Faster drug reviews are overshadowed
As a former regular on Fox 太子探花, Makary was aggressive about promoting his accomplishments on cable television and podcasts and in online opinion pieces.
More than a half-dozen initiatives from Makary aimed to speed up or streamline FDA drug reviews, including dropping certain study requirements, incorporating artificial intelligence into drug evaluations and offering expedited reviews to medicines that support 鈥渘ational interests.鈥�
But pharmaceutical executives rely on the predictability and consistency of FDA decisions, even more than speedy reviews. Makary鈥檚 efforts on drug reviews were overshadowed by internal conflicts and upheavals that created headaches for drugmakers, investors and patients.
A number of specialty drugmakers studying therapies for rare or hard-to-treat diseases said they received rejection letters or requests to run additional studies for drugs that had previously been given the go-ahead by FDA staff. Those drugs were primarily overseen by Prasad, who stepped down for a second time from his role as FDA鈥檚 vaccine and biotech chief in April.
Vaccine moves denounced
Prasad repeatedly overruled vaccine staffers to restrict eligibility for new COVID shots. In February, Prasad initially refused to even consider Moderna鈥檚 mRNA shot for flu. The after Moderna pledged to formally challenge the decision and called for intervention by the White House.
Some of Makary and Prasad鈥檚 most controversial vaccine proposals never came to fruition, despite stoking confusion and anxiety within the FDA and beyond.
In an internal memo in November, Prasad claimed 鈥� without publishing evidence 鈥� that the FDA had linked COVID shots to the deaths of 10 children. Prasad used that to justify a planned wholesale overhaul of the agency鈥檚 approach to approving and updating vaccines.
A dozen former FDA commissioners issued a scathing denunciation of the plan, warning it would 鈥渦ndermine the public interest鈥� and decimate vaccine development. The FDA has not released its analysis of the deaths or its plan for the vaccine overhaul.
FDA’s drug center had a revolving door
In the FDA鈥檚 drug center, which is the agency’s largest division, Makary oversaw a revolving door of leadership changes. Six people served as director over the course of one year.
Makary鈥檚 initial pick for the job, Dr. George Tidmarsh, was after allegations that he used his FDA position to pursue a personal vendetta against a former business partner.
His replacement, longtime FDA cancer specialist Dr. Rick Pazdur, announced he would retire after just three weeks on the job, after clashing with Makary on multiple issues involving drug reviews.
With Makary’s departure, the fate of many fledgling initiatives is uncertain.
Most of the programs Makary introduced have not gone through federal rulemaking required to enshrine them in U.S. regulations and could easily be overturned by his successors.
Democrats in Congress have questioned the legality of some of those efforts, including a program that offers drugmakers expedited reviews for innovative medicines.
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