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Lawmakers Slam FTC Generic Biologic Report

Law360 (June 5, 2009, 12:00 AM EDT) -- The Federal Trade Commission's suggestion Thursday that 12 to 14 years of data exclusivity for generic biologics is unnecessary rankled U.S. House of Representatives commerce subcommittee members, who called for more analysis on how follow-on biologic regulation might affect biotechnology investment, competition and safety.

The FTC defended in a hearing Thursday its recent report calling for U.S. Food & Drug Administration regulation of follow-on biologics — or FOBs, generic versions of complex biologic drugs — in which it claimed existing patent law and market-based pricing encouraged...
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