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Policy

Senate advances biogenerics bill

July 2, 2007 | APPEARED IN VOLUME 85, ISSUE 27

Kennedy
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Credit: Courtesy of Edward Kennedy
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Credit: Courtesy of Edward Kennedy

Legislation that would give FDA authority to approve less-expensive generic versions of biological medicines was approved last week by the Senate Health, Education, Labor & Pensions Committee. Brand-name drug manufacturers would receive 12 years of exclusive marketing time before generic competition could begin. "The bill reflects a balanced approach that enables patients to have safe, effective, and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public," says Sen. Edward M. Kennedy (D-Mass.), committee chairman. The outlook for the measure is uncertain. Biotech companies want 14 years of marketing exclusivity, while generic drugmakers contend the 12-year period is too long. "Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more important, would unjustifiably delay access to affordable competition and choice," says Kathleen Jaeger, president of the Generic Pharmaceutical Association. The Judiciary Committee will review the proposal before it goes to the Senate floor.

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