Low-hanging fruit at the FDA
Perhaps the simplest way to lower costs, speed innovation and even improve health would be to give the FDA the funding it needs to evaluate new treatments and drugs more quickly.
Five years ago, the FDA typically approved a new generic drug within 16.3 months of the application’s filing, according to a report from the agency on Tuesday. But by last year, with limited staff to review an increasing number of applications, approvals for new generic drugs were taking 26.7 months, the report said.
There is no doubt that plenty of generic drugs have reached the market, as they now account for more than 70 percent of prescriptions filled in the United States. The generics industry has saved consumers nearly $750 billion over the last decade, Dr. Hamburg said at the conference.
But the number of applications for new generic drugs is far outstripping the agency’s capacity to review them, she said. As a result, the agency now has a backlog of nearly 2,000 pending generic applications — more than double the backlog in 2005.
There are things we could do to improve the health-care system that will be very hard. And then there are things we can do that will be very easy. This is one of those easy things.
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