Congress Weighs Value Of Pediatric Exclusivity

Law360, New York (June 7, 2007, 12:00 AM EDT) -- Legislation in Congress would lower the amount of market exclusivity that drug makers are awarded for pediatric testing of their drugs, a development the U.S. Food and Drug Administration opposes.

A provision of the U.S. Senate drug user fee bill, S.1082, would lower pediatric exclusivity from six months to three months if the drug is considered a blockbuster, or one that made over $1 billion in annual sales.

The bill has already passed in the Senate. The U.S. House of Representatives is considering how to approach...
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