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Patients, companies cheer as FDA speedily green-lights drugs. Others are alarmed

· December 6, 2019 ·

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.Global Blood Therapeutics Inc., maker of a new sickle cell disease drug called Oxbryta, built a booth to showcase the medicine at the annual meeting of the American Society of Hematology that begins this weekend — even though the Food and Drug Administration’s scheduled approval date had been set for the coming March.The move paid off: Oxbryta was given the go-ahead by the FDA on Nov. 25, more than three months ahead of schedule, and the branded booth will make its debut at the ASH conference in Orlando, Florida, on Saturday.“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 … [Read more...] about Patients, companies cheer as FDA speedily green-lights drugs. Others are alarmed

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