Trade Group Blasts "Authorized Generic" Deals

Law360, New York (March 3, 2004, 12:00 AM EST) -- Generic drug makers denounced the practice of "authorized generics," arguing that such agreements devalue the 180-day exclusivity provisions of the Hatch-Waxman Act.

"We urge the U.S. Food and Drug Administration to maintain the spirit and intent of the 180-day exclusivity period which was strengthened in last year's Medicare reform bill," said Kathleen Jaeger, President and Chief Executive Officer of the Generic Pharmaceutical Association (GPhA), an industry trade group.

Under "authorized generics" agreements, a brand drugmaker licenses its product to a generic firm, which launches the authorized...
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