Published Online: Wednesday, November 1, 2006

Congressional generic drug advocates are pushing for legislation for creating new fast-track procedures for the FDA to use in approving generic biopharmaceuticals for marketing. The bill, introduced by Rep Henry Waxman (D, Calif) and Sen Charles Schumer (D, NY) as the "Access to Life-Saving Medicine Act," could save billions of dollars for consumers and taxpayers by establishing a clear, efficient abbreviated pathway for approval of generic versions of such biopharmaceuticals as Epogen (epoetin alfa), Neupogen (filgrastim), and Avonex (interferon β-1a).

Although biopharmaceuticals hold the promise of improving the lives of millions of patients, they can be prohibitively expensive. Noting that some of these treatments cost up to $100,000 per year, a spokesman for the Generic Pharmaceutical Association (GPhA) said that "without generic versions, the costs will cripple the health care system and keep needed treatments out of the hands of consumers."

Likening the proposed new legislation to the landmark 1984 Hatch-Waxman Act, GPhA President Kathleen Jaeger said that now "Congress has the opportunity again to help countless Americans access lifesaving biopharmaceuticals that are safe, effective, and affordable."

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