According to the New York Times, President Trump has succumbed to pressure from various insiders at HHS and elsewhere to get rid of FDA Commissioner Makary. Dr. Makary came with a great resume. The following is from Wikipedia:
He practiced surgical oncology and gastrointestinal laparoscopic surgery at Johns Hopkins Hospital, was Mark Ravitch Chair in Gastrointestinal Surgery at Johns Hopkins School of Medicine, and was the chief of Islet Transplant Surgery at Johns Hopkins. He is now Professor Emeritus at Johns Hopkins.
Makary has pioneered advanced laparoscopic procedures, including the first laparoscopic Whipple and Frey’s procedures at Johns Hopkins, and led the development of “the Surgery Checklist” in collaboration with the World Health Organization. Makary has held several leadership roles at Johns Hopkins…. He has published on surgical safety, frailty, teamwork, and hospital quality, and has advocated for public reporting of physician-endorsed quality measures, price transparency, and reform in drug pricing.
When the Senate set about confirming Dr. Makary, the view was that Trump had appointed a qualified, talented, noncontroversial commissioner. Yet, the mood inside the FDA turned sour immediately, although this was not necessarily Makary’s fault. The Department of Government Efficiency (DOGE) took a toll on the FDA staff, laying off 3,500 staffers, many of whom had to be rehired later due to a backlog of work. Getting rehired after getting fired does not make one feel appreciated or loyal.
The FDA is stogy agency staffed by dinosaurs. Makary sought to streamline the agency’s approval process, but the FDA has done things the same way for decades. He made some decisions (like removing the black box warning from hormone replacement) without having numerous committee meetings to reach a consensus first. At the same time, he did not rubber stamp drug applications that he felt were lacking evidence, saying:
“If your drug works, it’s going to get approved,” Makary said. “Do you throw science out the window do… whatever the lobbyists and corporate interests tell you to do, or do you do what’s right?”
Makary’s goal was to make sure a drug is effective before approval. That ruffled drugmakers’ feathers. He hired Vinay Prasad, who served as the Director of the Center for Biologics Evaluation and Research (CBER) and the agency’s Chief Medical and Scientific Officer. Prasad left and returned to the FDA before leaving again in April 2026. Dr. Prasad was unpopular. He annoyed rare disease advocates and drugmakers for rare diseases when he criticized gene therapies that were ineffective, often dangerous and cost more than most families earn in a lifetime.
An underlying criticism that created enemies was Makary’s unwillingness to bend the federal agency to the whims and demands of special interest groups. He was criticized for not using the power of his office to restrict access to mifepristone, a medication approved 26 years ago and used to treat Cushing’s Syndrome but also used for abortions. Pro-life groups are angry that Makary would not fast track a study of abortion pill safety (and presumably make sure the results serve their political purposes). They also thought Makary should have done more to restrict the sale of abortion pills.
Makary also made enemies when he stalled the approval of fruit flavored nicotine vapes, because it would lead to more teens becoming addicted to vaping. He pushed new regulations restricting food dyes and chemical additives in foods, making both friends and enemies. Reporting to both Robert Kennedy Jr. and President Trump would be a challenging task for anyone. NYT had this to say:
He tried to walk the tightrope between the business-friendly Make America Great Again movement, pledging to get rid of regulations that slow down innovation and to 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, voicing the 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 seeing biotech therapies authorized.
Despite a few missteps, I thought Makary was doing a great job at the FDA. He did not join the FDA with the goal of maintaining the status quo. Nor did he bend the agency to suit political purposes. His goal was to streamline the approval process but make sure new drugs work. That is the kind of FDA commissioner we need.
Read more at:
WaPo: White House Prepares to Replace FDA Leader Marty Makary Amid Agency Turmoil
WSJ: Trump Is Planning to Fire FDA Commissioner Marty Makary