BioCentury
ARTICLE | Editor's Commentary

Prasad’s downfall signals a shift to libertarian regulation

The challenge for industry and patients is to couple misplaced enthusiasm for right-to-try with science-based approaches to generating evidence

August 1, 2025 10:58 PM UTC

Vinay Prasad’s fall from grace was astonishing. He seemed to defy gravity, rising to great heights on the updrafts of powerful patrons, only to plummet, like Icarus, in a flash.

Life sciences companies need to understand Prasad’s journey because it conveys essential lessons about FDA’s approach to regulating medicines. One of the lessons is that politics and ideology have permeated FDA, affecting personnel and regulatory decisions that in the past would have been insulated from external influences...