Dr. Marty Makary resigned as commissioner of the Food and Drug Administration on Tuesday after roughly a year in the job, ending a tenure that had drawn fire from pharmaceutical executives, vaping lobbyists and anti-abortion groups in roughly equal measure. President Trump named Kyle Diamantas, the FDA's top food official, as acting commissioner.
Makary's exit leaves the agency that regulates the U.S. drug, food and medical-device industries without a permanent head at the same moment it is renegotiating the Prescription Drug User Fee Act, weighing a politically charged safety review of the abortion pill mifepristone and processing a backlog of rare-disease applications whose recent rejections have alarmed biotech investors.
What forced it
A senior administration official told CNBC that no single decision drove the departure, but that Health and Human Services Secretary Robert F. Kennedy Jr. made the final call. The White House had grown impatient with what it viewed as slow movement on Trump priorities, including the legalization of flavored vapes, CNBC reported. The Susan B. Anthony Pro-Life America organization had publicly called for Makary's ouster after the FDA, under his direction, slow-walked a safety review of mifepristone, the abortion drug that can be mailed into states with abortion restrictions.
Leaving the White House on Tuesday, Trump told reporters Makary "was having some difficulty," according to PBS NewsHour. In separate remarks captured by CNBC, the president called Makary a "wonderful man" and said, "He's going to go on, and he's going to lead a good life."
Inside the agency
The departures had been piling up for weeks. Dr. Richard Pazdur, the FDA's longtime cancer regulator, left the agency and cited Makary's leadership as his reason. Vinay Prasad, the polarizing official Makary installed over vaccines and biotech treatments, stepped down at the end of April after the agency reversed itself on a Moderna flu shot it had initially refused to review and after gene-therapy maker uniQure said the FDA was demanding it perform what the company called fake brain surgery to test a Huntington's disease treatment.
In April, the FDA rejected Replimune's melanoma drug for a second time, citing insufficient evidence and a single-arm trial design. In a CNBC interview the same month, Makary defended the call. "I don't work for Replimune, I work for the American people, and I stand by the scientists at the FDA," he said.
The successor
Diamantas takes over on an acting basis, and the administration hopes to name a permanent nominee within weeks, the senior official told CNBC. Confirmation will likely require the support of Sen. Bill Cassidy, R-La., the physician who nearly blocked Kennedy's own confirmation and whom Trump has since endorsed a primary challenger against.
The pharmaceutical industry, despite its frustration with the recent rejections, is wary of a shake-up while the user-fee reauthorization is on the table. Sen. Ron Johnson, R-Wis., in March opened an investigation into the agency's rare-disease decisions, a probe Makary's successor will inherit alongside the mifepristone review.
No Democratic lawmaker had publicly weighed in by Tuesday evening, and the White House did not say whether the new nominee would back the flavored-vape and mifepristone moves that Makary resisted.