The FDA is granting fewer accelerated approvals and pushing more drugmakers to remove unproven uses from their medicines. The tougher stance comes as accelerated approval faces new scrutiny.
Amid the latest controversy, FDA leaders have taken unprecedented steps suggesting a tougher stance on accelerated approval: nudging drugmakers to remove a growing list of unproven uses for drugs and asking Congress for new powers to expedite removals when companies balk.
Launched in 1992, the accelerated approval program is credited with speeding the availability of early breakthroughs for HIV and cancer. About 300 drug approvals have been made that way, nearly half of them in the last five years.But researchers and government watchdogs have chronicled problems with FDA’s oversight, including delays in quickly removing drugs with failed or missing confirmatory studies.
“We need more teeth in terms of getting the confirmatory trials started before accelerated approval,” FDA Commissioner Robert Califf said at a recent cancer conference. “Once approval occurs it’s very difficult to hold back the marketeers.” To be sure, FDA approval trends are impacted by a variety of forces. The agency’s overall tally of novel drugs is down markedly this year at about 30, compared with 50 last year. And even the recent peak in use of the accelerated pathway — 45 approvals in 2020 — reflected several trends.
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