FDA Commissioner Marty Makary Resigns After One Year in Trump Administration

Food and Drug Administration Commissioner Marty Makary resigned from his position on Tuesday, leaving a vacancy at the top of the agency already facing turnover in its drug and biologics divisions. Makary joined the Trump administration one year before his resignation.

It was then that he joined Health and Human Services Secretary Robert F. Kennedy Jr. and National Institutes of Health Director Jay Bhattacharya on the X platform in a 58-second video. In that video, the three announced that the Covid-19 vaccine would no longer be routinely recommended for healthy pregnant women and children.

Joshua M. Sharfstein served as principal deputy commissioner of the FDA from March 2009 to January 2011. During the first months of the Obama administration, Sharfstein kept two lists on his desk: priorities moving along at a reasonable speed, and priorities that he was struggling to push forward.

The Department of Government Efficiency team dismissed thousands of scientists and other career officials as Marty Makary arrived at the FDA. Makary walked into what Sharfstein described as a mess, with an unstable HHS where career officials were fired, the CDC’s vaccine advisory committee was wiped out, grants arbitrarily suspended, discredited researchers hired or appointed, and scientific reports blocked.

Makary established a “Commissioner’s National Priority Voucher” to expedite review of drug applications.

Some companies opted out because of concerns that political interference was making the process untenable. He brought energy and introduced some good ideas, including releasing the FDA’s reasons for failing to approve applications, actions that were long overdue. Actions on difficult topics are most credible when supported by fair processes with integrity, Sharfstein wrote.

Every presidential administration sets policy direction then confronts the difficulty in altering the federal government’s course. The credibility of decisions depends on a respected agency showing its work. Instead of convening advisory committees, Makary brought together rubber stamp panels to endorse the administration’s agenda, according to Sharfstein.

They announced policy by press release or journal commentary rather than through official, vetted documents. By the end of his tenure, it was hard to fault those who thought all of the agency’s decisions were Makary’s alone. The American Academy of Pediatrics still recommends the Covid-19 vaccine for young children.

Even Kennedy’s own CDC has had to acknowledge the value of Covid vaccination during pregnancy, Sharfstein noted. A year later, the initial policy shift from the video announcement had not altered those positions. Sharfstein argued 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. Political appointees should set timelines while accelerating hiring, contracts, grants and regulation updates, then engage transparently with humility when final decisions are made.

With more than two years to go in the administration, Sharfstein pointed to President Trump’s nominee for CDC director as 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.