659. Can Marty Makary Fix the F.D.A.?

What It Covers

FDA Commissioner Marty Makary discusses his plans to accelerate drug approvals, eliminate animal testing requirements, modernize food guidelines, regulate AI in healthcare, and address autism treatments while navigating political controversies in the Trump administration.

Key Questions Answered

• •Drug Approval Speed: FDA reduces application review time from one year to weeks by convening offices simultaneously rather than sequentially, making decision letters public so companies understand exact approval criteria and rejection reasons, eliminating the black box regulatory process.
• •Animal Testing Elimination: Organ-on-chip technology and computational modeling prove more predictive than animal testing, which has 90% failure rate for human safety. FDA eliminates requirements starting with monoclonal antibodies, which currently use average 144 chimpanzees per drug tested.
• •Priority Review Incentives: Companies receive expedited FDA review worth $500 million if they commit to most-favored-nation pricing matching other developed countries, manufacture domestically for national security, or address large unmet public health needs, using market forces to lower drug costs.
• •Leucovorin for Autism: FDA approves generic drug leucovorin for cerebral folate deficiency in autism based on clinical trials showing 20% of children with severe autism have marked improvement, 30-40% show some benefit by bypassing blocked folate receptors in brain.