STAT March 25, 2024
NEW YORK — Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated approval pathway, allowing regulators to speed access to drugs for thousands of dying patients.
These days, though, Gonsalves sounds uneasy — if not mournful — of the world he helped build.
“We’re approving drugs faster and faster — [the FDA is] one of the fastest regulatory agencies in the...