Thursday, January 14, 2010

FDA's Approvable Problem

They scuttle product launches and send company stocks through the floor. They steal precious years from patents and require pricey new trials. They have the entire drug industry on edge, from struggling one-hit biotechs to struggling large-cap pharmas. They're FDA approvable letters—that odd regulatory response that isn't quite an approval and isn't quite a rejection—and in the past three or four years, they've become a major part of the FDA's arsenal for dealing with (or, as many say, not dealing with) new drug applications (NDAs).

As of October 1, the agency had already issued 23 approvable letters this year, including second letters for four drugs and a third for one. After hearing industry insiders grumble that a scared-safe FDA was upping the letter's use, Chris Milne of the Tufts Center for Drug Development looked into the issue in 2005 and counted 35 approvable letters for NDAs between 2001 and 2004, causing an average delay until approval of 20 months. FDA has issued 36 such letters since January 2006 alone.

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Author(s): 
Walter Armstrong
Journal: 
Pharmaceutical Executive, Nov 1, 2007

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