FDA Chief Dr. Marty Makary Resigns After Turbulent Year of Political Clashes and Industry Backlash

Trump FDA chief is leaving after angering pharma CEOs, vaping lobbyists and anti-abortion groups

WASHINGTON (AP) -- The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after a rocky tenure that drew months of complaints from health industry executives, anti-abortion activists 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 official announcement and insisted on anonymity. Makary, a surgeon and health researcher, came to the attention of Republican operatives as an outspoken critic of COVID-19 health measures during the pandemic when he frequently appeared on Fox News. But he struggled to manage the FDA's bureaucracy and failed to win the confidence of its staff after mass layoffs, leadership changes and a series of controversies in which the agency's scientific principles appeared to be overridden 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's interest in scrutinizing of the safety vaccines, drugs and food additives. Virtually all of FDA's 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's handpicked deputy, Dr. Vinay Prasad, was pushed out of the agency twice 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 the abortion pill mifepristone, 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 new flavored e-cigarettes seen as crucial to the industry's survival. As a former regular on Fox News, 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 "national interests." But pharmaceutical executives rely on the predictability and consistency of FDA decisions, even more than speedy reviews. Makary's 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's vaccine and biotech chief in April. Prasad repeatedly overruled vaccine staffers to restrict eligibility for new COVID shots. In February, Prasad initially refused to even consider Moderna's mRNA shot for flu. The FDA was forced to reverse itself after Moderna pledged to formally challenge the decision and called for intervention by the White House. Some of Makary and Prasad's 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 -- without publishing evidence -- 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's approach to approving and updating vaccines. A dozen former FDA commissioners issued a scathing denunciation of the plan, warning it would "undermine the public interest" and decimate vaccine development. The FDA has not released its analysis of the deaths or its plan for the vaccine overhaul. In the FDA's 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's initial pick for the job, Dr. George Tidmarsh, was forced to resign 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. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Trump FDA Chief Leaving After Controversial Tenure

WASHINGTON (AP) -- The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after a rocky tenure that drew months of complaints from health industry executives, anti-abortion activists 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. Makary, a surgeon and health researcher, came to the attention of Republican operatives as an outspoken critic of COVID-19 health measures during the pandemic when he frequently appeared on Fox News. But he struggled to manage the FDA's bureaucracy and failed to win the confidence of its staff after mass layoffs, leadership changes and a series of controversies in which the agency's scientific principles appeared to be overridden 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's interest in scrutinizing of the safety vaccines, drugs and food additives. Virtually all of FDA's 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's handpicked deputy, Dr. Vinay Prasad, was pushed out of the agency twice 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 the abortion pill mifepristone, 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 new flavored e-cigarettes seen as crucial to the industry's survival. As a former regular on Fox News, 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 "national interests." But pharmaceutical executives rely on the predictability and consistency of FDA decisions, even more than speedy reviews. Makary's 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's vaccine and biotech chief in April. Prasad repeatedly overruled vaccine staffers to restrict eligibility for new COVID shots. In February, Prasad initially refused to even consider Moderna's mRNA shot for flu. The FDA was forced to reverse itself after Moderna pledged to formally challenge the decision and called for intervention by the White House. Some of Makary and Prasad's 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 -- without publishing evidence -- 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's approach to approving and updating vaccines. A dozen former FDA commissioners issued a scathing denunciation of the plan, warning it would "undermine the public interest" and decimate vaccine development. The FDA has not released its analysis of the deaths or its plan for the vaccine overhaul. In the FDA's 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's initial pick for the job, Dr. George Tidmarsh, was forced to resign 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. ___