Trump Appoints Johns Hopkins Surgeon Makary as New Head of FDA
On Friday, President-elect Donald Trump appointed surgeon Marty Makary from Johns Hopkins University as the new head of the Food and Drug Administration (FDA), selecting a well-regarded medical researcher known for his unconventional views on vaccination during the COVID-19 crisis.
If confirmed as FDA commissioner, Makary will manage a team of approximately 18,000 employees tasked with evaluating new drugs and medical devices, assessing the effectiveness of existing treatments, and ensuring food safety. The FDA’s responsibilities include reviewing more than 50 new pharmaceutical products and biological therapies annually.
With a focus on pancreatic surgery, Makary represents a more conventional selection compared to Trump’s earlier nominations: Robert F. Kennedy Jr. for the Department of Health and Human Services and Mehmet Oz for the Centers for Medicare and Medicaid Services.
Both the FDA and CMS operate under HHS, giving Kennedy considerable influence over the two agencies alongside Trump’s healthcare policies, as his vaccine stance has alarmed some within the medical community. In making these three nominations, Trump underscored each appointee’s readiness to challenge established practices within their respective agencies.
“The FDA has lost American trust and strayed from its core mission as a regulator,” Trump remarked in a statement on Truth Social. “The agency requires Dr. Marty Makary, a respected surgical oncologist and health policy authority from Johns Hopkins, to redirect and realign its objectives.”
Makary has published numerous research papers covering subjects from surgical techniques to patient safety and healthcare expenses. He wrote a 2016 review of the Orphan Drug Act, critiquing how pharmaceutical companies manipulate regulations to protect rare disease treatments while later marketing them more broadly.
He has also penned several books, including one named “Blind Spots,” which challenges what he perceives as prevailing scientific groupthink and calls for more rigorous evaluation of medical beliefs regarding issues like peanut allergies.
Although Makary identifies as “pro-vaccine,” he diverges from Kennedy’s stance, expressing opposition to widespread vaccine mandates and questioning vaccination strategies aimed at young adults and children. In a recent article, he and co-authors declared that certain university policies enforcing COVID booster shots in 2022 were unethical, citing more significant risks than benefits.
If he takes on the role of FDA commissioner, Makary will face the complex challenge of maintaining the FDA’s credibility on vaccine matters while navigating the skepticism from Kennedy and other right-leaning figures.
The FDA commissioner operates under the health secretary, succeeding Robert Califf, who led the agency during President Biden’s and President Obama’s administrations.
Unlike Califf, Makary’s experience with clinical trials involving new medications appears limited; he is acknowledged as the lead investigator in a U.S. government trial database for a study on post-surgical chemotherapy for pancreatic cancer, but that trial never commenced.