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President-elect Donald Trump on Friday named Johns Hopkins University surgeon Marty Makary to lead the Food and Drug Administration, choosing a prolific medical researcher who bucked consensus on the necessity of frequent vaccination during the COVID-19 pandemic.
As FDA commissioner, Makary would oversee an agency of some 18,000 employees who assess new drugs and devices, review the performance of approved medicines and monitor food quality and safety. The agency typically evaluates and makes decisions on more than 50 new drug and biological products each year. The FDA also regulates medication abortion, including mifepristone, which was at the center of a U.S. Supreme Court case earlier this year. In June, the Supreme Court ruled unanimously to preserve access to the medication.
Makary, whose specialty is pancreatic surgery, is something of a more traditional health nominee than Trump’s controversial picks of Robert F. Kennedy Jr. to lead the Department of Health and Human Services and Mehmet Oz to run the Centers for Medicare and Medicaid Services.
Both the FDA and the CMS are overseen by HHS, giving Kennedy, who has alarmed many in the medical community with his views on vaccines, substantial power over the two agencies and Trump’s healthcare agenda. And in naming all three, Trump emphasized their willingness to take on industry and shake up the agencies he’s selected them to lead.
“FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator,” Trump wrote in a statement late Friday on Truth Social. “The agency needs Dr. Marty Makary, a highly respected Johns Hopkins surgical oncologist and health policy expert to course-correct and refocus the agency.”
Makary has authored many papers published in medical journals on topics ranging from pancreatic surgery protocols to patient safety and healthcare costs. Among them is a 2016 critique of the Orphan Drug Act that scrutinizes drugmaker tactics to secure protections for rare disease drugs they later expand to wider use.
He’s also the author of several books, including one titled “Blind Spots” that attacks what Makary describes as scientific “groupthink” and advocates for greater scrutiny of medical dogmas on topics like peanut allergies.
Makary doesn’t appear to hold the same anti-vaccine views as Kennedy, describing himself as “pro-vaccine” in a 2021 editorial published by U.S. News. But he opposed broad vaccine mandates and criticized COVID vaccination policies for young adults and children.
In a journal article this year, for example, he and other researchers argued that university mandates requiring students to receive COVID boosters in 2022 were “unethical,” because they caused more harm than good.
If confirmed as FDA commissioner, Makary would have the difficult job of balancing the FDA’s scientific credibility on vaccines — which he has appeared to support broadly — with the skepticism and at times outright opposition of Kennedy and other conservative leaders.
FDA commissioners report to the health secretary. Makary would replace Robert Califf, who has served as the FDA’s head under President Joseph Biden and former President Barack Obama.
Unlike Califf, Makary does not appear to have been involved in many clinical trials testing experimental drugs. He is listed as the chief investigator of an interventional study in the U.S. government’s trial database but that test, of chemotherapy following pancreatic cancer surgery, was never started.
