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GPhA Praises Bipartisan House Introduction of Bill to Block Authorized Generics During 180-Day Exclusivity Period

ARLINGTON, VA, February 6, 2007-- The Generic Pharmaceutical Association (GPhA) today praised U.S. Representatives Jo Ann Emerson (R-MO), Zach Wamp (R-TN), Marion Berry (D-AR), and Dennis Moore (D-KS) for introducing legislation (H.R. 806) to block the marketing of authorized generics during the 180-day exclusivity period awarded to the first generic to successfully challenge a frivolous or questionable brand patent. The bill is a companion to "The Fair Prescription Drug Competition Act of 2007" (S. 438) introduced in the Senate last week.

"The 180-day exclusivity period has spurred competition, resulting in greater availability of safe and affordable medicines for consumers," said GPhA President and CEO Kathleen Jaeger. "We applaud the efforts of Representatives Emerson, Wamp, Berry and Moore to eliminate barriers to bringing generics to market. We look forward to working with House and Senate co-sponsors to pass this important legislation."

When the Hatch-Waxman Act was passed in 1984, Congress wisely granted a 180-day period of exclusivity to generic companies to spark competition and ensure that checks and balances were built into the drug development system. Unfortunately, brand pharmaceutical companies are circumventing Congressional intent by using tactics like authorized generics to keep generic companies from bringing their safe, effective and affordable medicines to consumers by discouraging generic companies from challenging questionable brand patents.

Under provisions in the Hatch-Waxman Act, the first generic company to successfully challenge a questionable brand patent and receive approval to market that drug product is awarded 180-day exclusivity. This 180-day period was designed to permit the generic company alone to compete with the brand company, allowing the generic to recoup costs incurred for undertaking a patent challenge. Brand companies are circumventing the Act’s intent by introducing an authorized generic -- which is the brand’s own product repackaged and marketed either through a subsidiary or third-party -- during this critical timeframe.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 56% of the total prescriptions dispensed in the United States, but less than 13.1% of all dollars spent on prescription drugs.

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