Media

Press Release

GPhA Supports Bill to Block Authorized Generics and Restore the Value of the 180-Day Generic Exclusivity Period - Applauds Senators Rockefeller, Schumer, Leahy and Kohl for Introducing “The Fair Prescription Drug Competition Act of 2007”

ARLINGTON, VA, January 31, 2007-- The Generic Pharmaceutical Association (GPhA) today applauded Senators John Rockefeller (D-WV), Charles Schumer (D-NY), Patrick Leahy (D-VT), and Herb Kohl (D-WI) for introducing legislation, “The Fair Prescription Drug Competition Act of 2007” (S. 438), to block the marketing of an “authorized generic” during the 180-day exclusivity period awarded to the first generic drug manufacturer that successfully challenges a brand patent. The 180-day exclusivity period, established under the Hatch-Waxman Act of 1984, is a critical incentive for generic companies to challenge frivolous and questionable brand pharmaceutical patents and bring affordable medicines to consumers.

“Under Hatch-Waxman, Congress wisely granted a 180-day exclusivity period to generic companies to encourage competition and ensure that there are checks and balances built into the drug approval system. Authorized generics undermine Congressional intent because they only enter the market during the 180-day exclusivity period. This devalues the 180-day exclusivity period, which is a critical incentive to bring generics to market in a timely manner,” said GPhA President and CEO Kathleen Jaeger. “We applaud Senators Rockefeller, Schumer, Leahy and Kohl for their leadership in bringing safe, effective and affordable generics to consumers.”

Under provisions in the Hatch-Waxman Act, the first generic company to successfully challenge a questionable brand patent, file an abbreviated new drug application (ANDA) with FDA 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. Moreover, because the brand is selling part of its product as a generic, it is not required to go through the rigorous, abbreviated approval process required by a true generic.

“Simply put, authorized generics are yet another attempt by brand-name companies to stifle competition and put profits over consumers,” Jaeger noted. “By banning authorized generics, this legislation is putting consumers over brand company profits. That’s good news for patients and our healthcare system.”

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. For more information about the industry, visit www.gphaonline.org.

• More press releases
• Other resources in Authorized generics