Makary's exit creates new uncertainty at FDA

"There's lots of uncertainty around how the Senate will find the bandwidth to confirm another FDA commissioner while it considers President Trump's nominees for Centers for Disease Control and Prevention director and surgeon general. The FDA itself is also facing other key internal vacancies, including for directors of the centers overseeing drugs and biologics. And there are questions about whether a successor will continue efforts to streamline clinical trials and other regulatory actions."

"On Tuesday, Trump confirmed Makary was out after facing internal criticism for not accommodating some of the president's priorities, as well as complaints from health care investors about unpredictable regulatory decisions that rejected some promising drugs. "Marty is a great guy. He was having some difficulty," Trump told reporters, in response to questions about whether he resigned or was fired. He later wrote on Truth Social that the Johns Hopkins physician and researcher "was a hard worker, who was respected by all, and will go on to have an outstanding career in medicine.""

"The task of steering the agency for the moment will fall to Kyle Diamantas, a Florida lawyer and reported friend of Donald Trump Jr. who was heading the FDA's food center. Between the lines: David Mansdoerfer, a senior HHS official in the first Trump administration, wrote on X that Diamantas had the regulatory and legal chops to lead a transition and also was "a good pick for MAHA, and a good pick for business.""

Senate confirmation uncertainty surrounds the ability to appoint another FDA commissioner while nominees for CDC director and surgeon general are considered. The FDA also faces other internal leadership gaps, including directors for centers overseeing drugs and biologics. Questions remain about whether a successor will maintain efforts to streamline clinical trials and other regulatory actions. Trump confirmed Marty Makary’s departure after internal criticism tied to insufficient accommodation of presidential priorities and complaints from health care investors about unpredictable regulatory decisions that rejected some promising drugs. Trump said Makary was having some difficulty and later praised him on Truth Social. Kyle Diamantas, who led the FDA’s food center, will steer the agency temporarily, and potential successors have included Stephen Hahn and Brett Giroir, alongside calls from multiple health-related interest groups for a reset.

Read at Axios