President Trump approved a plan to fire Dr. Marty Makary, commissioner of the Food and Drug Administration, after a series of clashes over vaping, abortion pill oversight and a series of denials of new drug applications that shook biotechnology companies, according to a person briefed on the matter, who was not authorized to discuss it publicly.
Dr. Makary had a high profile for an FDA commissioner, frequently appearing on television and podcasts to sell the work he was doing at the agency to improve the food supply, speed up some drug approvals and try to restore agency morale after thousands of staff members left.
He tried to walk a tightrope between the pro-business Make America Great Again movement, promising to get rid of regulations that stifle innovation and attract more drug trials to the United States. He was an ally of Health Secretary Robert F. Kennedy Jr.'s Make American Healthy Again supporters, expressing skepticism of the pharmaceutical industry and authorizing natural food dyes.
Ultimately, Dr. Makary's efforts were not enough to overcome the grievances of a growing band of enemies focused on selling tobacco, opposing abortion, and authorizing biotechnological therapies.
Trump's decision to fire him was first reported by The Wall Street Journal.
The decision could still change, given Trump's propensity to change his mind. Dr. Makary has also proven persuasive with Trump by rejecting previous efforts to overthrow him.
Leaving the White House on Friday night, Trump dismissed the idea that Dr. Makary would be fired.
“I've been reading about this, but I don't know anything about it,” he said.
The White House has pressured Dr. Makary for months to authorize flavored e-cigarettes, according to a person close to the talks. The approvals were the main desire of the major tobacco companies that have been Trump's biggest donors. In March, the FDA issued a memo saying it would only authorize e-cigarettes with flavors such as mint, tea and spice. The memo said fruit and candy flavors were unlikely to be approved, given their appeal to young people.
The pressure continued, however, and on Tuesday the FDA cleared cranberry-mango flavored e-cigarettes from Glas, a small company based in Los Angeles.
Abortion foes, including Susan B. Anthony Pro-Life America, have continued to ramp up pressure on Dr. Makary, reiterating their call for his firing on Thursday. The group's leaders and others believe Dr. Makary is dragging his feet on a review of the safety of the abortion pill mifepristone, which they see as a way to highlight what they believe are the dangers of the drug. Former Vice President Mike Pence, who also opposes abortion rights, also amplified criticism of Dr. Makary on social media.
The administration has been under pressure from conservatives to tighten regulations on the prescribing and dispensing of mifepristone. The Supreme Court is reviewing a federal appeals court ruling that temporarily blocked abortion providers from prescribing the drug via telemedicine and mailing it to patients.
Biotech companies and their investors have also raised alarms with the White House about the agency's decisions to reject a series of treatments for rare diseases. The FDA typically rejects about 20 percent of the applications it receives from companies for drug approval.
Dr. Makary has been aggressive in defending the decisions, which he says came from career scientists who found the drugs to be ineffective.
Dr. Makary also had to contend with a health secretary who seemed to view the FDA as a path to clearance for his favorite products, exemplified by Mr. Kennedy's social media post saying the agency would end its “war on” stem cell treatments, peptides and raw milk. Kennedy pressured the FDA to reverse a 2023 ban and allow the use of a number of peptides, unproven compounds that purportedly offer anti-aging or muscle-recovery benefits.
Before leading the FDA, Dr. Makary was a cancer surgeon and health policy researcher at Johns Hopkins University School of Medicine. He was also the author of several books on the health system.
Some of Dr. Makary's most popular actions included encouraging broader use of hormone replacement products for women and lifting FDA warnings on them. It helped accelerate the commercialization of some promising drugs, including a pancreatic cancer therapy and the pill form of the popular weight-loss drug GLP-1.
