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A challenge at the FDA: Getting new generics to market

Dan Gorenstein Nov 17, 2015
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A challenge at the FDA: Getting new generics to market

Dan Gorenstein Nov 17, 2015
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A Senate Committee will meet with Dr. Robert Califf, the president’s pick to head up the Food and Drug Administration, on Tuesday morning.

One of the most pressing problems facing the agency is boosting competition in the generic drug market. Right now, it takes a long time to bring a generic drug to market  48 months, according to the Generic Pharmaceutical Association.

“That means instead of having a generic drug on the market in a year, it’s taking four years,” said Yale health economist Fiona Scott Morton. “That’s three years we don’t have price competition for that medication.”

Getting one generic onto the market she says, can cut costs by as much as a third. And getting four or five competitors can cut costs by as much as 80 percent.

“It’s a massive savings,” she said.

Manufacturers peg the backlog of generic drugs at more than 4000, all while pharmaceutical spending increasesThe FDA said additional funding has helped double approvals this year, with more than 500 generics getting to market.

“I think that’s a start,” said Harvard’s Dr. Aaron Kesselheim. 

Kesselheim said given the value of generics, he hopes Senators push Califf on his plan to get as many of these drugs to market ASAP.

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