Marty Makary

Disrupting regulation
Alana Semuels
Bill Clark—CQ Roll Call/AP

Before being confirmed as the head of the U.S. Food and Drug Administration (FDA) on March 25, Dr. Marty Makary was an influential critic of the medical establishment, targeting hospitals on patient safety and criticizing the necessity of vaccine mandates. His book Blind Spots, published in Sept. 2024, became an instant New York Times bestseller and asserted that groupthink has plagued mainstream research on health and medicine. The Johns Hopkins pancreatic surgeon has continued this contrarian streak as FDA Commissioner, even as his agency battles low morale after losing around 3,500 workers—about 20% of the staff—to layoffs. Now, he is questioning whether the FDA will approve COVID-19 vaccines for next winter; requiring Novovax to run another clinical trial for its updated COVID-19 vaccine, a version of which has been out since 2022; and asking food companies to cut Red Dye No. 3 faster than planned.

“Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma companies ‘tens of millions of dollars,’” he wrote, on a post on X, about the Novovax clinical trial.