Who Will Be FDA’s Next Commissioner?

Familiar names from the first Trump administration are being floated as a replacement for Marty Makary, MD, MPH, who resigned as FDA commissioner last week.

Kyle Diamantas, JD, the FDA’s deputy commissioner for food, is now the agency’s acting commissioner. Prior to his work at FDA, Diamantas, a graduate of the University of Florida Levin College of Law, spent his legal career working with political and industry stakeholders, according to his agency bio.

Diamantas’ name has been tossed around as a potential contender to formally replace Makary, as have three physicians: Stephen Hahn, MD, Brett Giroir, MD, and Ned Sharpless, MD. The agency did not respond to MedPage Today‘s query about candidates to replace Makary.

Hahn is an oncologist and former FDA commissioner who held the job from December 2019 to January 2021, when he stepped down as part of the transition of power between administrations. In an interview with Bloomberg, he said he considered resigning after the January 6 capitol riot. He also got flak during the early COVID pandemic for granting hydroxychloroquine an emergency use authorization under pressure from the White House.

Before FDA, Hahn was the chief medical executive at the University of Texas MD Anderson Cancer Center in Houston and he has published hundreds of peer-reviewed research articles, according to his FDA bio.

Giroir, a four-star admiral in the U.S. Public Health Service Commissioned Corps, was the agency’s acting commissioner for a few weeks in late 2019. He also was Assistant HHS Secretary from 2018 to 2021 and the COVID “testing czar” during Operation Warp Speed.

Sharpless was acting FDA commissioner from April 5 to Nov. 1, 2019 and director of the National Cancer Institute from 2017 to 2022 (except for the months he was leading FDA). Before that, he was director of the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, his agency bio states.

On his blog “FDA Matters,” Steven Grossman, an FDA regulatory and policy consultant, wrote that Diamantas is a “stabilizing choice” as acting commissioner. While Diamantas is a lawyer, not a doctor or public health expert, Grossman said this isn’t cause for concern in an acting commissioner since there are plenty of doctors at FDA to offer him advice. Grossman hopes that as a lawyer, Diamantas may be inclined to follow FDA’s traditional decision-making processes.

Under Makary’s leadership, FDA often veered from established agency processes, such as with his so-called expert panels that side-stepped standard pathways for scientific discussions and drew concerns about cherry-picked experts and evidence.

As for the others, Grossman told MedPage Today that it’s unlikely any of them will be the final candidates. While they are getting attention, he says it’s because they are known and associated in some way with Trump’s first term — not because they are necessarily viable. He suspects that Diamantas will be in the role for months since he can legally remain as acting commissioner until after the midterms. Grossman doesn’t think there will be a permanent FDA director anytime soon.

“All the obvious candidates are unlikely to be able to run the gauntlet of competing positions to satisfy the White House, be Senate-confirmable, and contribute, or at least not detract from, Republican Congressional wins in the midterms,” he said. Hot topic issues like Louisiana’s lawsuit against FDA that threatens mail access to the abortion drug mifepristone would certainly come up in FDA confirmation hearings, which may not benefit the administration’s ideal candidates.

Grossman said that the FDA “has a DNA for how it carries out its responsibilities,” which includes listening to interested partners, following the science, and engaging in transparent decision-making processes prior to drawing conclusions.

“Any nominee who understands this and commits to it, will have started on the path to being a successful FDA commissioner,” he said. “The goal is to be sure that the nominee for permanent commissioner has serious clinical medical or public health credentials. Whether that happens is unsure.”