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.
further underscored the program’s shortcomings. FDA has been trying to get the drug, Makena, off the market for more than two years, because a follow-up study showed it didn't benefit infants or mothers. The manufacturer has refused to cooperate.
An FDA spokeswoman said the agency's posture on accelerated approval “has remained consistent and the agency is committed to ensuring the integrity of the program.” She added that FDA is using “every authority at our disposal” to make sure drugmakers quickly conduct confirmatory studies after approval.
The picture is beginning to change. In less than two years, the FDA has successfully called on drugmakers to remove more than 20 approvals from accelerated drugs — mainly— that failed to show a benefit. That’s more than half the withdrawals in the program’s history. “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.”
A higher bar could spell trouble for smaller drugmakers, who often rely on accelerated approval to gain a market foothold before raising additional funds. Additionally, COVID-19 pandemic disruptions forced some drugmakers to cut short their research plans, asking FDA for accelerated approval based on partially completed studies, instead of a full results.
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