While President-elect Donald Trump has already made his leadership picks for the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS), a crucial spot for the biopharma industry remains open at the FDA.

The name on the top of the list for the next administration's FDA commissioner is Johns Hopkins surgeon and author Martin Makary, Reuters and Bloomberg reported this week, citing sources familiar with the matter.

England-born Makary, current chief of Inlet Transplant Surgery at Johns Hopkins, has received worldwide recognition for his achievements in novel surgeries and widely-used research, including a World Health Organization-sponsored checklist on surgical safety.

On the drug policy front, Makary has previously raised concerns about pharmaceutical companies “gaming the system” of the Orphan Drug Act, a pathway used to usher in treatments for rare diseases.

More recently, Makary has been an outspoken critic of vaccine mandates during the pandemic, which “ignored natural immunity,” he argued in 2023 remarks to the Senate’s COVID subcommittee. During the pandemic, natural immunity and herd immunity were topics often addressed by Makary, who expected the concepts to help COVID be “mostly gone” by April 2021.

The possible FDA commissioner pick has also argued against the use of masks for children to reduce the spread of COVID and has been accused of using misleading claims to make criticisms of the U.S. government.

Trump’s choice for HHS secretary, Robert F. Kennedy Jr., has already ramped up speculation about vaccine schedules in the U.S. given his history of anti-vaccine and vaccine-skeptical rhetoric. Recently, though RFK Jr. has pledged not to “take vaccines away from anybody."

If officially nominated and confirmed by the Senate to lead the FDA, Makary would report to RFK Jr.

Still, while the FDA falls under the HHS umbrella, there is “little precedent in recent history for HHS policy dictating or affecting FDA regulation or approval of drugs,” BMO analyst Evan Siegerman pointed out in a recent note.

During his last term, Trump selected oncologist Stephen Hahn, M.D., and physician Scott Gottlieb, M.D., to lead the FDA. It’s unclear how Makary would lead the agency in comparison to Hahn and Gottlieb but ahead of this week's reporting by Reuters and Bloomberg, BMO's Seigerman expected Trump’s eventual choice to be “supportive of government and industry cooperation.”

Meanwhile, the biopharma industry is gearing up to work with the upcoming administration to "strengthen our innovation ecosystem and improve health care for patients," PhRMA’s CEO Stephen Ubl said in a recent statement.