Opinion: Marty Makary misunderstood something fundamental about the FDA

OpinionFirst Opinion Marty Makary misunderstood something fundamental about the FDA There is not, and never has been, a ‘deep state’ to shove aside Manage alerts for this article Email this article Share this article By Joshua M. SharfsteinMay 16, 2026 Sharfstein served as principal deputy commissioner of the FDA from March 2009 to January 2011. On Tuesday, Food and Drug Administration Commissioner Marty Makary resigned from his position, leaving a vacancy at the top of the agency to match the turnover already challenging its drug and biologics divisions. It was just a year ago that Makary joined Health and Human Services Secretary Robert F. Kennedy Jr. and National Institutes of Health Director Jay Bhattacharya on the X platform to triumphantly announce in a 58-second video that the Covid-19 vaccine would no longer be routinely recommended for healthy pregnant women and children. The video exuded the elation of Covid response skeptics at long last grabbing the reins of power.Advertisement But Makary and his colleagues in the Trump administration misunderstood how to bring about lasting and meaningful change at FDA. Actions on a wide range of difficult topics are most credible and durable when they are supported by processes that are fair and have integrity. Every presidential administration sets the policy direction for the massive apparatus of the federal government — and then confronts the difficulty in altering its course. During my first months at FDA during the Obama administration, I kept two lists on my desk: priorities moving along at a reasonable speed, and priorities that I was struggling to push forward — and there was nothing on the first list. The FDA is always a unique management challenge, and Makary walked into a mess. As he arrived, the Department of Government Efficiency team dismissed thousands of scientists and other career officials, decimating offices responsible for essential functions. He had to navigate an unstable HHS, where Kennedy and his team fired career officials at the FDA and other agencies who didn’t agree with him, wiped out the CDC’s vaccine advisory committee, arbitrarily suspended grants, hired or appointed discredited researchers, and blocked scientific reports.Advertisement The problem isn’t just that so many HHS actions have lacked justification. Or that many have caused lasting damage to programs that save lives. Or even that some broke the law. The administration’s norm-shattering masks a more fundamental misunderstanding of how administrative power can bring about lasting change. There’s no “deep state” to shove aside. The credibility of decisions depends on a respected agency showing its work. Makary’s tenure at FDA is Exhibit A. From vaccines to medications for rare diseases, he and his deputy Vinay Prasad — who left the agency, returned, and then left again — overruled staff scientists, based on the repeated assertion that they were bringing back “gold standard science and common sense.” They announced policy by press release or journal commentary rather than through official, vetted documents, which could have addressed key questions. Instead of convening advisory committees, Makary brought together rubber stamp panels to endorse the administration’s agenda. Makary established a “Commissioner’s National Priority Voucher” to expedite review of drug applications, but some companies opted out because of concerns that political interference was making the process untenable. Makary brought energy, introduced some good ideas, and took some actions — like releasing the FDA’s reasons for failing to approve applications — that were long overdue. On any given topic, it was possible to agree or disagree with him. But the erosion of the integrity of the agency’s decision-making has been unmistakable. By the end of his tenure, it was hard to fault those who thought all of the agency’s decisions were Makary’s alone — leaving multiple companies and advocacy groups furious at him for every disappointment. There is another way to move the FDA forward. It starts with setting goals — such as helping people avoid chronic illness, reducing unnecessary chemicals in the food supply, accelerating the review of drugs for rare diseases, and improving the science of vaccine safety. It then allows the ideas to be vetted by career staff with understanding of the relevant law and subject matter, as well as by advisory committees and the public. Political appointees should set timelines for agency work, while accelerating processes for hiring, making contracts, giving grants, and updating regulations.Advertisement Then, when it’s time for final decisions, the commissioner and other politically appointed leaders should engage transparently and with a touch of humility, recognizing that reversing ideas or decisions that emerge from due consideration might not be worth the damage to the agency’s reputation and effectiveness. Alas, it’s not at all clear that the administration has learned this lesson. To satisfy specific constituencies, the White House or Kennedy may well demand the next FDA commissioner make specific changes to the regulation of medications and vaccines related to reproductive health, mental illness, infectious disease, or cancer. But regulation by email signature line is not an approach that deserves respect or is likely to last, just as a decision by a committee stacked with vaccine opponents may generate confusion but is not one that families, pediatricians, or insurers are likely to follow. Indeed, a year later, the American Academy of Pediatrics still recommends the Covid-19 vaccine for young children, and even Kennedy’s own CDC has had to acknowledge the value of Covid vaccination during pregnancy. With more than two years to go, there is plenty of time for a new direction. President Trump’s nominee for CDC director is a credible public health leader. Combined with a fresh start for a responsible FDA commissioner, the two might model what it means to work with — and within — their agencies to pursue a responsible agenda. Joshua M. Sharfstein, M.D., served as principal deputy commissioner of the FDA from March 2009 to January 2011. Letter to the editor Have an opinion on this essay? 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