
FDA Commissioner Marty Makary is getting fired, according to news reports
Key Takeaways
- The Wall Street Journal reports that FDA Commissioner Marty Makary is being fired, signaling imminent leadership disruption at the federal drug, biologics, and device regulatory agency.
- Marty Makary’s background includes Johns Hopkins academic leadership and a public profile as a bestselling author, factors that initially supported perceptions of appointment strength.
The Wall Street Journal is reporting that President Donald Trump has signed off on Makary's dismissal.
President Donald Trump has signed off on a plan to fire FDA Commissioner Marty Makary as Makary came under attack from an array of groups, including some antiabortion groups, the vaping industry and some biotech interests.
The Wall Street Journal was the first news outlet to report that Trump was moving to oust Makary early this afternoon. Other major outlets soon followed.
All the news accounts were based on unnamed sources, and they all hedged the story in a similar fashion, saying that the plan was not final.
“Trump’s plan isn’t yet final and could change,” reported the Journal in a story that was updated at 5:34 p.m. Eastern Daylight Time.
Makary, a professor and surgical oncologist at Johns Hopkins who has written several best-selling books about healthcare, was seen as one of President Trump’s stronger healthcare appointments partly because of his academic credentials. But his tenure as leader of the federal food, drug and device regulatory agency has been a rocky one.Numerous news outlets have reported recently that he was held in low regard by the White House and that his ouster was, at the very least, a distinct possibility.
“Paranoia, turmoil and backlash: Inside the FDA under Marty Makary,” was the headline on a Bloomberg News story about his leadership at the FDA that was published earlier this week. The Journal’s editorial page, which operates independently from its news staff, has published a number of pieces sharply critical of Makary’s decision not to approve Replimune’s melanoma drug, RP1 (vusolimogene oderparepvec).
In an interview with CNBC this week, Makary defended the decision to issue a complete response letter—a form of rejection by the FDA — to Replimune. Makary said three review teams at the FDA had arrived at the same conclusion about Replimune’s drug and that the company had not followed an FDA recommendation to conduct a trial of its agent with a control group for comparison.
“The FDA clearly recommended the control group. The company clearly did not do the control group,” Makary said in the interview.
Later in the nearly 13-minute
Makary and Vinay Prasad, who was head of the director of the FDA’s Center for Biologics Evaluation and Research, were also criticized for decisions that rejected a gene therapy for Hunter syndrome, a rare neurogenerative disease, and added the requirement for a phase 3 trial of uniQure’s gene therapy for Huntington’s disease. Prasad also initially declined to review Moderna’s application for an mRNA vaccine against seasonal flu, although the FDA reversed course days later. Prasad, a controversial figure, left the agency in April but Makary praised him as he left.
In addition to antagonizing some in biotech sector and its supporters, Makary has come under strong attack from antiabortion groups for, they say, dragging out a review of the safety of mifepristone, one of the two drugs taken for medical abortions.
“FDA Commissioner Makary should be fired immediately. Indifference is completely unacceptable to millions of pro-life voters expecting the administration to act to save lives,” Marjorie Dannenfelse, president of Susan B. Anthony Pro-Life America, an antiabortion group, said in a news release on Monday.
Makary also ran afoul of vaping industry interests by holding back approval of fruit- and menthol-flavored pods. According to multiple news reports, Trump put pressure on Makary to approve the flavors, and the FDA approved them on Tuesday. Critics say the flavors entice children and young children to vape.
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