Big changes are coming to the U.S. Food and Drug Administration (FDA), and all eyes are on Martin Makary, President Donald Trump's pick to lead the agency. If confirmed, Makary will face the challenge of keeping the FDA's reputation as the "gold standard" among global drug regulators, all while dealing with budget cuts and answering to an unconventional boss—Health Secretary Robert F. Kennedy Jr., who has been openly skeptical about vaccines.
Makary’s nomination comes at a turbulent time. The FDA has already been thrown into controversy following the mass firing of federal employees and the abrupt cancellation of an advisory meeting that was supposed to discuss the seasonal flu vaccine. This decision, made shortly after Kennedy’s confirmation, has raised concerns among lawmakers and public health officials alike.
His confirmation hearing is set for Thursday, where he will appear before the Senate Health, Education, Labor, and Pensions Committee. Expect tough questions, especially from Democrats, about his stance on mifepristone—a medication used for medical abortion that has been the target of Republican-led efforts to restrict access. Additionally, his views on vaccines will likely be under scrutiny.
So, who is Martin Makary? A physician at Johns Hopkins Hospital in Baltimore, he has long been vocal about what he calls an “epidemic of inappropriate care” in the U.S. medical system. He has pushed back against overtreatment, arguing that unnecessary procedures and prescriptions are a massive problem.
During the COVID-19 pandemic, Makary made headlines for taking some controversial stances. He opposed vaccine mandates for the general public and emphasized the protection provided by natural immunity. While these positions set him apart from many public health officials, those familiar with his work insist that he supports vaccination overall.
Dr. Cody Meissner, a professor of pediatrics at Dartmouth and a past collaborator of Makary, described him as "a very bright guy" with a strong record in medicine. "He understands the importance of vaccines, and I would in no way consider him to be an anti-vaxxer," Meissner noted.
However, his new boss, Robert F. Kennedy Jr., has a more complicated history with vaccines. Kennedy has been vocal about his belief that chronic disease rates are linked to regulatory failures and has often questioned the relationships between FDA employees and the pharmaceutical industry. Though Kennedy disputes being an “anti-vaccine” activist, his skepticism toward certain vaccines has fueled controversy for years.
The concerns about vaccine policies under Makary’s leadership were amplified last week when three Democratic U.S. Senators—Patty Murray, Tammy Baldwin, and Angela Alsobrooks—sent him a letter. They demanded answers regarding the cancellation of the FDA advisory panel’s meeting on the 2025-2026 flu vaccine and pressed him to clarify whether he would uphold a science-based approach or continue what they see as a dangerous drift toward vaccine skepticism.
Beyond vaccines, Makary is also walking into an FDA facing significant staffing turmoil. Just last month, hundreds of federal jobs were slashed as part of a government-wide effort to reduce spending. Led by Elon Musk and his Department of Government Efficiency (DOGE), this cost-cutting spree has sparked debate about the long-term impact on agencies like the FDA. Interestingly, many of those cuts were quickly reversed, and the agency is now offering early retirement packages instead.
Industry leaders are watching closely. Jeremy Levin, CEO of Ovid Therapeutics and a biotech veteran, has expressed concerns that Makary may have to defend the agency against further cuts. "A lot of people who are looking to simply cut costs have raised the specter—but not the fact—that they will do wholesale cutting at the FDA," Levin said. "I'm hopeful that Marty will be in a position to push back if necessary."
As Makary prepares for his confirmation hearing, there’s no shortage of challenges ahead. Can he balance the FDA’s mission with the political pressure from both his boss and the broader Trump administration? Will he defend the agency’s independence, or will cost-cutting measures and ideological shifts reshape it? The answers to these questions will define his tenure and could have a lasting impact on public health in the U.S.
One thing is clear: This isn’t going to be a quiet confirmation process. With major policy debates ahead, Martin Makary will need to navigate some serious political and medical minefields as he takes on one of the most influential roles in American healthcare.
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