Patient advocates debate FDA’s accelerated approval process- STAT

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 world — we know less and less about them, and we pay more and more for them,” said Gonsalves, now a professor at Yale, at STAT Breakthrough Summit East on Thursday. “So in that way, the system is not working. We basically put access out there as this talisman of hope, but we don’t compel the companies that give us answers about what these drugs do in our bodies.”