Makary is a pancreatic surgeon at Johns Hopkins who became known for battling medical mistakes and in recent years has been an outspoken critic of COVID-19 policies.
Johns Hopkins surgeon Martin Makary is the leading pick for the top FDA position in President-elect Donald Trump’s incoming administration, according to several media reports on Wednesday.
Citing two sources familiar with the matter, who requested to remain anonymous because they were not authorized to divulge this information publicly, Devdiscourse reported Makary could enact significant changes in the FDA.
The choice of Makary is not yet final, according to the sources. In a statement to Bloomberg, Karoline Leavitt, a spokesperson for the Trump transition team, said that “President-elect Trump is making decisions on who will serve in his second administration. Those decisions will continue to be announced by him when they are made.”
Makary is the chief of islet transplant surgery at Johns Hopkins, where he also serves as a public policy researcher. Makary has also been elected to the National Academy of Medicine and has received the Nobility in Science Award from the National Pancreas Foundation. He developed a widely-used checklist to prevent errors in the operating room, and went on to publish several books criticizing medical mistakes and other aspects of the health care system.
More recently, he has become an outspoken critic of the FDA’s—and the Biden administration’s—COVID-19 policies. In August 2023, Makary penned an opinion article for The Wall Street Journal that blasted the government’s decision to approve and roll-out a coronavirus booster without what he saw as sufficient human data.
As FDA chief, Makary would report to the Secretary of the Department of Health and Human Services, to which Trump last week announced he will appoint Robert F. Kennedy Jr.—a controversial pick given his strong anti-vaccine positions. Kennedy founded Children’s Health Defense, a nonprofit that rose to prominence during the COVID-19 pandemic, during which it worked to discredit vaccinations.
On its website, Children’s Health Defense continues to make disproven claims that vaccines can cause asthma, autism, developmental delays and other chronic conditions in children.
The emergence of Makary’s name as a likely pick also follows Trump’s announcement that Mehmet Oz will be nominated as Administrator for the Centers for Medicare and Medicaid Services. Oz “will be a leader in incentivizing Disease Prevention, so we get the best results in the World for every dollar we spend on Healthcare in our Great Country,” Trump wrote in a statement.
Reacting to these appointments, Jefferies analyst Michael Yee in a Wednesday note predicted “increased investor uncertainty in biopharma,” especially as “Trump is close to selecting other key health roles [including] FDA Commissioner [potentially] in line w/ RFK related views.”
“We don’t see a fundamental impact to key areas of biotech innovation especially orphan diseases, cancer drugs, and inflammation/autoimmune,” Yee continued, however noting that investors will be concerned about the stability of relevant agencies. “These distractions and the unpredictability could be factor over the near term,” he added.