Watch CNBC's full interview with FDA Commissioner Marty Makary

Summary

FDA Commissioner Marty Makary defends the agency's recent drug rejection decisions, particularly the controversial Replimune melanoma therapy, and outlines a series of regulatory reforms aimed at accelerating clinical trials and restoring U.S. biotech leadership. He pushes back against media criticism and corporate lobbying, emphasizing that science guides every decision.

• Makary defends FDA's rejection of Replimune's melanoma therapy, citing manufacturing violations and trial design issues.
• He claims three independent review teams reached the same conclusion on the drug.
• Makary highlights reforms including moving to single pivotal trials, reducing animal testing, and launching real-time clinical trials.
• He notes the FDA approved a record 67 drugs last year and expedited a pancreatic cancer drug in two days.
• Makary criticizes corporate lobbying and media pressure, citing nine Wall Street Journal opinion pieces pushing for one drug.
• He warns that China surpassed the U.S. in Phase 1 trials during the Biden administration and vows to restore U.S. biotech leadership.
• The commissioner rejects allegations of a paranoid management style and says the FDA is embracing radical transparency.
• The interview focuses on restoring trust in the FDA's scientific integrity and accelerating approval of meaningful treatments.