A Political End to an Unusually Political FDA Commissioner


Marty Makary, the Johns Hopkins surgeon who has led the FDA for the past year, is facing criticism from all sides. Vaping advocates are upset because of the FDA’s slow progress on green lights for their products. Pro-life groups have called for Makary to be fired because he has not been tough enough on abortion. Current and former FDA officials have repeatedly warned that the agency is in disarray. Even drug companies, usually cautious about criticizing regulators, have raised concerns about the agency’s status. Donald Trump has it now is reported signed a plan to oust Makary—although exactly when the ax might fall is unclear. On Friday evening, the president told reporters gathered at the White House that he did not know anything about Makary’s future.

Traditionally, FDA commissioners have been relatively small figures; they have handled their role as stewards of an organization whose strength derives from its independence. The logic of that position is simple: Putting drugs on the market just because of the whims of a commissioner or president, or burying politically expedient research, does not inspire much confidence in the safety of American food and drugs. But Makary has shown time and time again that he is willing to put politics first, a strategy that may have set the stage for his resignation. (Neither Makary nor the White House agreed to comment for this story.)

Problems began shortly after Makary’s confirmation. In June, he announced the launch of the Commissioner’s National Priority Voucher, a pilot program intended to provide expedited approvals for drugs that “are consistent with one of America’s top five national health priorities.” The program quickly became a tool of political influence. The FDA often expedites review of essential drugs, but drugs that are given a golden ticket must address a significant unmet medical need. With the new program, all decisions to issue vouchers were canceled by the White House, STAT news information. Therefore, vouchers seemed to be the basis of negotiations in negotiations with pharmaceutical companies on their prices. On the same day that the White House announced that Eli Lilly and Novo Nordisk would drop the price of their GLP-1 weight loss drugs and sell them on a Trump-branded website, both companies were also given vouchers for new weight loss drugs.

Makary and his deputies have also repeatedly defeated labor workers, often for overtly political motives. During his confirmation hearing, for example, Makary promised lawmakers that he would “take a hard look at the data” on the safety of the abortion drug mifepristone. And although Makary has claimed that FDA scientists have begun reviewing the data, the news broke in December that he had also instructed FDA staff to delay the review until after the midterm elections. (At the time, the Department of Health and Human Services, which oversees the FDA, denied any political motivations.) Vinay Prasad, whom Makary had hired as director of the Center for Biologics Evaluation and Research, replaced a longtime FDA official who had fallen out with Secretary Robert F. Kennedy Jr. over vaccine safety; Prasad it quickly moved to reduce access of young, healthy people to COVID vaccines. Prasad was also behind the FDA’s short-term decision prevent inspection a new mRNA flu vaccine. He said that these decisions were motivated by the need for strong evidence, but were also consistent with Kennedy’s personal doubts about COVID and mRNA vaccines. Both of these decisions were reportedly made against the advice of FDA staff. (Prasad has since been pushed out of the agency.)

Ironically, the scandal that could cost Makary his job — the FDA’s reluctance to approve the sale of flavored vapes — involves him ignoring the advice of FDA officials while misreading, or perhaps ignoring, the politics of the issue. The commissioner has expressed exceptional reservations about these products. He has said publicly that he does not believe the government’s own data that shows that the epidemic of vaping among young people has improved and only 5 percent of young people now have a vape. At a September 2025 press conference, he claimed that the “broken CDC that we inherited under the Biden administration” had used flawed methods to collect data. (The long-term study he referenced is generally considered the best source of national data on youth vaping.) According to The The Wall Street JournalMakary personally dissed FDA scientists who proposed approving flavored vapes that include ingredients designed to prevent use by anyone under 21.

But Makary was prioritizing his wishes before the president. Trump seems to see vaping as a political issue: During his campaign, he publicly promised to save the industry, and he is reported to be faced Makary about the FDA’s approach to vaping. It’s unclear whether this confusion is exactly what made Trump seriously consider firing Makary, but shortly after he was fired, the FDA announced that vapes that the commissioner had previously banned would now be approved.

Makary entered this job worried about agency. His book 2024, Blind Adsis full of criticism of FDA decisions that he says represent “medical doctrine.” And in a recent CNBC interview in which he was confronted about a decision during his tenure not to approve a skin cancer drug, he appeared like his predecessors in denouncing political pressure. “You have a decision when you come in as commissioner: Do you throw science out the window and do whatever the media tells you to do, and whatever lobbyists and corporate interests tell you to do, or do you do what’s right?” He said. And some of the recent trickery the FDA has received has come from companies and commenters who thought the agency was withholding approval or solicitation. too a lot of evidence. Not all controversial calls for better data came from Makary or Prasad, either; during the review of skin cancer therapy, for example, calls for more data it came from longtime FDA officials.

It’s easy enough for the FDA commissioner to make enemies. What people put into their bodies is controversial, and the FDA commissioner has to make tough decisions about products from powerful companies with good resources. Makary is not the first commissioner to face political pressure, but he is the only one who has made it a habit. A different criticism of Makary is related: It shows how, time and time again, he puts his own or his superiors’ wishes first. These decisions may end his career as commissioner, but they have already set a dangerous precedent for political interference in the agency.



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