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FDA Approving Drugs at Breakneck Speed, Raising Alarm
By Michelle Cortez and Cristin Flanagan
December 6, 2019, 9:00 AM CST Corrected December 6, 2019, 3:09 PM CST

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 deadline for approval was Feb. 26.

The move paid off: Oxbryta was given the go-ahead by the FDA on Nov. 25, almost 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 to stay. In areas of high unmet need, FDA seems to be committed to getting medicines to these people as fast as possible.”


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Oxbryta’s approval added to a growing number of breakthrough products that have beaten their FDA deadlines by weeks and sometimes months. For normal medicines, the agency typically has 10 months to issue a ruling. For those with exceptional benefits, or that treat conditions with few existing therapies, it offers a priority review that takes just six months. From mid-October to mid-November, the agency approved five medicines in as little as eight weeks.

The shift is emerging as the FDA is approving new drugs at a record pace, and breakthroughs in biotechnology and genetics are enabling drug companies and their scientists to provide more specific data to federal regulators.

“It isn’t that we changed our policies and are saying we are going to approve drugs faster,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who joined the agency under President Ronald Reagan. “The difference now is we are going to see more of those because of the science. If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible.”

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.....

I am posting an excerpt from the article. For the entire article, see this: https://www.bloomberg.com/news/articles/2019-12-06/fda-is-green-lighting-drugs-at-breakneck-speed-and-raising-alarm

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