FDA Would Collect Millions in Fees to Speed Review of Traditional and Biotech Generic Drugs

Publication: The Associated Press

Author: Matthew Perrone


01/13/2012 - The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement with industry released by the agency on Friday.

The user fee proposal is one of three such agreements that the agency is submitting to Congress for approval by lawmakers. The agreements would each charge drug manufacturers application fees for reviewing traditional drugs, generic drugs and a new class of generic biotech drugs, respectively.

The FDA has used industry fees to hire extra staff to review regular prescription drugs since 1992. One of the proposals unveiled Friday extends that approach to generic drugs, which have long had slower review times.

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“These agreements are important because they are a substantial resource that lets the agency carry out its mission of protecting patients and ensuring important products come to market in a timely way,” said Allan Coukell, director of the Pew Charitable Trusts’ health advocacy group. “For the first time we will also have funding directed at increasing FDA’s inspection of foreign manufacturing facilities.”

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Read the full Associated Press article, FDA Would Collect Millions in Fees to Speed Review of Traditional and Biotech Generic Drugs, on the Washington Post's Web site.

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