FDA Commissioner Marty Makary defends Replimune drug approval decision
Food and Drug Administration (FDA) commissioner Martin Makary during a press conference at the U.S. Food and Drug Administration headquarters in Silver Spring, Maryland, United States, on Tuesday, April 28, 2026.
Valerie Plesch | Bloomberg | Getty Images
U.S. Food and Drug Administration Commissioner Marty Makary defended himself in a CNBC interview published Tuesday after months of pressure over recent drug rejections.
The relentless heat reached a new fever pitch this week with a detailed report from Bloomberg News. “paranoia, turmoil and backlash” at the agency under Makary’s tenure. One opinion piece Asked by The Wall Street Journal if any administration official has created more headaches for President Donald Trump than Makary. The article specifically touched on the FDA’s controversial rejection of a drug candidate for melanoma. Reply.
“I think the article in the Wall Street Journal is the ninth article they’ve published in this opinion section seeking Replimune’s approval,” Makary said in an interview with CNBC’s David Faber. he said. “I don’t work for Replimune, I work for the American people and I stand with the scientists at the FDA.”
Three independent teams came to the same conclusion, Makary said, adding that the FDA does not make “corrupt lover deals.” Replimune representatives said the FDA treated the company unfairly.
Makary said stands behind review teams, and it’s been a “disaster” every time FDA commissioners overrule agency scientists. He cited examples such as the FDA’s approval of an Alzheimer’s disease drug called Aduhelm and the approval of a Covid-19 vaccine booster for young, healthy children.
