FDA Chief Defends Rejections Amidst Mounting Pressure
Key Event
FDA Commissioner Marty Makary, in a CNBC interview on Tuesday, defended recent drug rejections by the agency amid increasing pressure, including a Bloomberg News report detailing internal turmoil and a Wall Street Journal opinion piece criticizing his leadership.
"I don't work for Replimune, I work for the American people, and I stand by the scientists at the FDA."
Statements
- Makary stated that three independent review teams reached the same conclusion on the Replimune melanoma drug candidate, which the FDA rejected.
- He argued that FDA commissioners overruling agency scientists has historically been a "disaster," citing the approval of Aduhelm for Alzheimer's and a COVID-19 vaccine booster for young children.
Context
- The Wall Street Journal editorial questioned whether any administration official has created more problems for President Trump than Makary.
- Replimune has stated that the FDA treated the company unfairly.