FDA Commissioner Marty Makary defends Replimune drug approval decision
Key Points:
- FDA Commissioner Marty Makary defended the agency's recent drug rejections amid mounting criticism, emphasizing his commitment to public interest over pharmaceutical companies.
- Makary responded to a Wall Street Journal opinion piece criticizing the FDA's rejection of Replimune's melanoma drug, stating he supports the scientific conclusions of three independent review teams.
- He rejected allegations of corruption or favoritism within the FDA and highlighted past instances where overruling agency scientists led to problematic drug approvals.
- Makary cited controversial approvals like the Alzheimer's drug Aduhelm and a Covid-19 vaccine booster for young children as examples of the risks when commissioners override scientific advice.
- The interview reflects ongoing tensions and scrutiny of the FDA under Makary's leadership, with media reports describing internal turmoil and backlash.