The Pro-Vaccine Surgeon Who Will Soon Report to RFK Jr.

The Atlantic

06-03-2025

Leading the FDA has long been one of the greatest professional achievements in American health. At the start of every administration, doctors jockey for the role, hoping to steer an agency that r egulates 20 cents of every dollar spent in the United States. To be the FDA commissioner who presides over the approval of a cure for a previously intractable disease, or who launches an investigation into a product that is sickening Americans, is to etch your name into the annals of modern medicine. Perhaps you've never heard of David Kessler, the FDA commissioner for much of the 1990s, but he is largely the reason the federal government regulates cigarettes at all.
Marty Makary, Donald Trump's pick for FDA commissioner, is undoubtedly qualified for the job. A longtime Johns Hopkins surgeon and best-selling author, he has advised the World Health Organization and been elected to the National Academy of Medicine. (Makary, whose confirmation hearings kicked off in the Senate this morning, told Senator Rand Paul that he spent part of yesterday removing a patient's gallbladder.) Makary is not universally embraced: As a Fox News contributor, he has repeatedly critiqued the medical establishment on air. But he's still widely regarded as well credentialed. 'He has the ability to become one of the greatest commissioners we've seen,' Kavita Patel, a physician and former Obama-administration official who considers Makary a personal friend, told me.
But Makary might end up with one of the worst jobs in the entire Trump administration. His scientific bona fides are at odds with the impulses of his boss, Robert F. Kennedy Jr. The newly confirmed secretary of Health and Human Services, who has a penchant for spreading conspiracy theories, has promised lawmakers that he will empower scientists and won't 'impose my preordained opinions on anybody.' But he has also promised to change the agency so radically that delivering on that vision would require Makary to throw much of his medical training out the window. What Makary decides to do will go a long way in determining the extent to which Kennedy is able to remake American health in his image.
That's not to say that Makary, who did not respond to a request for comment, will be waging a war of resistance against everything RFK Jr. wants and believes. During his testimony this morning, Makary spoke about his desire to improve America's diet and address chronic disease—both of which Kennedy has made his central focus as America's health secretary. 'We now have a generational opportunity in American health care,' Makary said. 'President Trump and Secretary Kennedy's focus on healthy foods has galvanized a grassroots movement in America.' Last fall, he took part in a roundtable with Kennedy where he lamented that 'highly addictive chemicals' lace the U.S. food supply. Tackling that issue will be Makary's surest bet for delivering on what Kennedy wants.
Contrary to Kennedy's long-standing anti-vaccine advocacy, Makary reiterated in his Senate testimony that he believes that 'vaccines save lives.' But like Kennedy and several other prominent Trump health advisers, Makary has been a vocal critic of how the Biden administration handled COVID. In 2021, he called out the FDA's decision to approve COVID boosters for young, healthy Americans, citing a lack of clear evidence for their benefits relative to the potential side effects. The government's 'policies are no longer driven by science,' he wrote at the time, and 'data is being cherry-picked to support predetermined agendas.' (The FDA pushed forward with boosters for young adults without convening its own independent advisory committee, though the agency said its decision was supported by data.) Other statements Makary has made are more questionable. In an appearance on Fox News in July 2023, he said that '100 percent' of Kennedy's book on Anthony Fauci was true. He didn't acknowledge that the book falsely claims that 'COVID vaccines were causing far more deaths than they were averting.' ('The Marty you might see on Fox News clips is obviously not the person I know,' Patel told me.)
Much of what Makary actually wants to do at the FDA remains unclear. He spent little time during his testimony on Thursday outlining his moves once confirmed. Still, most of the changes Kennedy wants to see at the agency are untenable for any FDA commissioner concerned about adhering to basic science. Kennedy has said that the FDA's 'war' on treatments such as stem cells and psychedelic drugs 'is about to end.' Decisions on how to regulate these products typically don't rest with the health secretary or the FDA commissioner, but with the agency's scientists and doctors. In both cases, there is no scientific reason for the FDA to change course. The agency doesn't allow stem-cell treatments for most conditions because they aren't proven to work and can cause people serious harm; last year, the FDA rejected what would have been the first MDMA-based medical treatment, likely due to shoddy clinical-trial data.
On his own, Makary can do only so much. The FDA's powers are actually given by law to the HHS secretary, who then has historically delegated powers to the FDA commissioner, according to Lewis Grossman, a law professor at American University. What is given can be taken away; if Kennedy wants to meddle in Makary's work, he's well within his rights to do so.
Still, should Makary stand up to Kennedy, he will not be the first FDA secretary to clash with more powerful officials in the administration. Kessler's efforts to investigate the tobacco industry were so controversial in Washington that, as he wrote in his memoir, the White House worried he would resign if they didn't allow him to continue his work. If Makary can conjure up a similar power—using whatever leverage and cache he would have as FDA commissioner to negotiate with Kennedy and the Trump White House—he may hold his own. Makary 'has both a mandate and an authority to not feel like he needs to step in line with any secretary, much less RFK Jr.,' Patel said.
The first major test for how willing Makary is to stand up to his boss will likely center on mifepristone, an abortion pill. Kennedy told senators in January that he would order the FDA and NIH to review the safety of the drug to determine whether access to it should be restricted. (Access to mifepristone varies by state, though prescriptions via telehealth have complicated the picture.) But that review has already been done. The FDA recently rereviewed the drug's safety information, and determined that previous restrictions around the drug, namely that patients needed to physically go to a clinic to get it, were unnecessary. The agency is unlikely to find any new evidence that the drug is especially dangerous. If Makary comes up with a reason to question its safety, and thus meddles with the agency's previous findings, it will show that his loyalty rests more with Kennedy than FDA's scientists. During his confirmation hearing, Makary was unwilling to preview how exactly he would come down on the issue, much to the frustration of some Democratic senators.
In any administration, overseeing the FDA's sprawling, vital work is a colossal undertaking. Should he be confirmed, Makary will be tasked with safeguarding the infant formula Americans feed their newborns, the cosmetics we use on our skin, the painkillers we take when we have a headache, the chemotherapy we receive to fight cancer, the pacemakers that keep hearts ticking, the flu shots we get every fall, and even the hand sanitizer we reach for when our hands are dirty. Makary's biggest challenge, however, could turn out to be his ability to manage up. His ideal version of the FDA presumably is different from Kennedy's. They both can't get their way.