The U.S. is approving new drugs so fast that companies are preparing for a green light months ahead of the scheduled decision date.
The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer advocates.
“It’s very much a change,” said Alethia Young, a biotechnology analyst at Cantor Fitzgerald in New York. “It has happened over the past five years, and it’s probably here to stay. In areas of high unmet need, FDA seems to be committed to getting medicines to these people as fast as possible.”Oxbryta’s approval added to a growing number of breakthrough products that have beaten their FDA deadlines by weeks and sometimes months.
But even as drugmakers, investors and patients cheer on the agency’s pace, patient-safety advocates argue that speed comes at a price. Studies show medicines approved on a faster time line are more likely to have safety problems emerge after they become broadly available, while other treatments offer fewer benefits than anticipated.While the Trump administration has focused on reducing regulation across the U.S., the FDA’s new-found speed had its genesis more than a quarter-century ago.
Clearance for Novartis AG’s Adakveo, another new medication for sickle cell disease, came in November. It was 62 days ahead of the FDA’s deadline, known as the PDUFA date. BeiGene Ltd.’s Brukinsa was approved three months ahead of schedule for mantle cell lymphoma. “We’re allowing drugs to come to market sooner, faster without having sufficient information about their safety,” said Michael Carome, health research group director at the consumer advocacy group Public Citizen. “Over the last few decades, the FDA’s standards for approving drugs have weakened, which has led to faster drug approval.”Take Makena, a treatment from AMAG Pharmaceutical Inc. that was supposed to delay preterm births.
“That increased risk that you take by approving drugs quickly is reasonable — if that drug is a very promising drug that meets an unmet medical need for a serious or life-threatening condition,” he said.
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