The accelerated approval program was implemented as the U.S. grappled with the HIV crisis and was searching for a way to get medicines for the deadly infection to market more quickly. But its use has skyrocketed in recent years, with 70 of the 278 speedy approvals awarded by the FDA occurring in 2020 and 2021 alone.
The FDA awards those clearances on “surrogate endpoints,” or biological data that researchers believe can predict benefits that take longer to assess. The agency requires drugmakers to conduct follow-up trials that are meant to confirm those benefits.
