Generic-drug approvals languish at FDA

The backlog of generic-drug applications at FDA is growing. With increasing numbers of applications--and not enough staff to review them--the amount of time a potential generic waits for approval grew to 26.7 months in 2009, up from 16.3 months back in 2005. It's an increase that Generic Pharmaceutical Association Chair and Watson Chief Executive Paul Bisaro calls "astonishing."

There are 2,000 generic-drug apps awaiting action at FDA right now, the New York Times reports. The longer they languish without review, the longer Medicare and other payers have to spend more on brand-name drugs. That may be good for branded drugmakers, but not so good for fighting fast growth in healthcare costs. As Bisaro tells the Times, "Those are direct tangible savings to consumers being lost."

At GPhA's recent annual meeting, FDA chief Margaret Hamburg promised to speed approvals along. Even generics makers agree that FDA's generics office is underfunded, even if they might not agree with Hamburg's solution to that problem: User fees. One way or the other, Hamburg says the agency will expedite things. As she told her audience at GPhA, "I don't pretend to believe that the status quo is acceptable."

- read the NYT story

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