Who Is Marty Makary? FDA commissioner under ‘exit’ pressure as Trump ‘signs off’ on removal plan

Makary took charge of the FDA in March 2025 after Senate confirmation. Before joining the agency, he worked as a surgical oncologist and professor at the Johns Hopkins University School of Medicine. He also built a public profile through bestselling books that criticized rising healthcare costs and what he called failures in modern medicine.

He became one of the most visible figures connected to Health Secretary Robert F Kennedy Jr and the administration’s “Make America Healthy Again” movement, often referred to as MAHA.

Makary has often pushed for stricter scientific reviews inside the FDA and backed placebo-controlled clinical trials for Covid-19 vaccines in lower-risk groups. He also oversaw changes in how the agency handled vaccine approvals, drug reviews and abortion medication policies.

Why did pressure grow around Marty Makary?

Reports about Makary’s possible removal increased over the past week as criticism inside the US and the biotech sector intensified. Several administration officials reportedly grew uneasy about the political fallout surrounding some FDA decisions under his leadership.

Makary faced criticism after the FDA rejected a treatment from Replimune Group through a complete response letter, reported WSJ. The company’s drug application failed because FDA reviewers said the trial lacked a proper control group.

Earlier, in an interview with CNBC, Makary defended the decision and said three FDA review teams reached the same conclusion. “The FDA clearly recommended the control group. The company clearly did not do the control group,” Makary said.

Later in the interview, he defended his broader approach to regulation. “You have a decision when you come in as commissioner. Do you throw science out the window and do what the media tells you to do and what the lobbyists and the corporate interests tell you to do, or do you do what is right?” Makary said.

Makary and former FDA official Vinay Prasad also faced backlash after the agency rejected or delayed several high-profile therapies. Critics targeted the FDA’s handling of gene therapy applications for Hunter syndrome and Huntington’s disease.

Prasad, who led the FDA’s Center for Biologics Evaluation and Research before leaving in April, also came under scrutiny after initially declining to review Moderna’s application for an mRNA-based seasonal flu vaccine. The FDA later reversed that decision.

Makary publicly praised Prasad after his departure, a move that reportedly added to tensions between FDA leadership and some White House officials, reported Reuters. The commissioner also faced pressure from anti-abortion groups over the FDA’s review of Mifepristone, one of the two drugs used in medical abortions.

Marjorie Dannenfelser, president of Susan B Anthony Pro-Life America, criticized Makary earlier this week. “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,” she said in a statement.

Makary also clashed with vaping industry groups after delaying approval of fruit- and menthol-flavored vape pods. According to multiple media reports, Trump later pressured the FDA to approve the products. The agency approved the flavors earlier this week despite criticism from public health advocates who argue such flavors attract teenagers and young users.

What’s next for FDA?

Makary’s expected departure would leave the FDA without a permanent commissioner during a period of major regulatory uncertainty. Several senior positions inside the agency already remain vacant or are filled by acting officials. That includes the FDA’s drug development divisions, where acting leaders currently oversee key decisions involving drug approvals, vaccines and food safety.

Public health experts have raised concerns about growing instability across federal health agencies, reported Reuters. Senior officials have left the Centers for Disease Control and Prevention and other health departments in recent months, creating fears about weakened institutional continuity.

Critics say that repeated leadership turnover makes it harder for agencies to retain experienced scientists and maintain long-term public health strategies. Some also fear the changes could weaken the government’s response to future health emergencies and disease outbreaks.

The White House has not officially confirmed Makary’s dismissal and has not named a possible replacement.