Speedier drug approvals hit slowdown as FDA faces scrutiny
The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs
WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders.
With less than a month remaining in the year, the FDA’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs.
The program allows drugs to launch in the U.S. based on promising early results, before they are proven to benefit patients.
Academics have long complained that the practice has resulted in a glut of expensive, unproven medications, particularly for cancer. But last year’s accelerated approval of a much-debated Alzheimer’s drug touched off a new round of criticism, including investigations of FDA’s decision making by federal inspectors and Congress.
