Biotech Values

[DewDiligence]

FDA to Offer Priority Review for Selected Generics

[This is a pretty big win for the generic manufacturers who had pushed for expedited reviews but had balked at paying user fees to the FDA. Please see #msg-9566322 for a graphic depiction of the magnitude of the backlog problem.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20061018:MTFH27605_2...

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WASHINGTON, Oct 18 (Reuters) - Bids to sell some generic drugs now will be prioritized to receive faster, six-month reviews from U.S. regulators, a top Food and Drug Administration official said on Wednesday.

Applications may undergo the expedited review if they are the first for a generic version of a drug no longer protected by a patent or market exclusivity, or if the medicine would address a public health emergency or nationwide shortage, said Dr. Steven Galson, director for FDA's Center for Drug Evaluation and Research.

The agency has a backlog of more than 800 generic drugs awaiting an approval decision under the current process that evaluates all applications in the order that it receives them. In 2005, the median time for an approval was more than 16 months, according to the FDA.

Under the new procedures, generic drug applications with priority status will expedited immediately, Galson said at a conference sponsored by the Generic Pharmaceutical Association.

"We should start seeing that right away, we think it's realistic," he said about the new six-month timeframe.

Top generic drugmakers include Teva Pharmaceutical Industries Ltd <TEVA>, Barr Pharmaceuticals Inc. <BRL>, Mylan Laboratories Inc. <MYL>, Watson Pharmaceuticals Inc <WPI> and Novartis AG's <NVS> Sandoz unit.
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