Overview
- Marty Makary remains commissioner, though multiple reports say he is on thin ice with the White House, even as a spokesperson calls him an invaluable asset and no formal ouster has been announced.
- The FDA cleared four new e-cigarette flavors, including blueberry and mango, hours after a report that President Trump had scolded Makary over slow action on vapes, with the agency stressing a scientific review and strict age checks.
- In a CNBC interview, Makary said he stands by FDA reviewers and that three independent teams reached the same call on Replimune’s melanoma drug, a claim challenged by a Wall Street Journal editorial and a reviewer’s post that alleged an initial team favored approval.
- High-profile turnover has added to the scrutiny, with vaccines official Vinay Prasad leaving and deputy Katherine Szarama selected to take over, moves critics frame as part of broader turmoil inside the agency.
- The pressure reflects wider disputes over consistency and speed in reviews, including an initial refusal and later reversal on Moderna’s mRNA flu filing and Makary’s push for AI tools and real-time trial pilots that promise faster decisions but raise concerns about rigor for patients and drugmakers.