FTC discusses generics
In a report released by the Federal Trade Commission (FTC; Washington, DC) in late July, officials are urging two rather technical legislative steps aimed at expediting market entry of generic drugs. In the report, “Generic Drug Entry Prior to Patent Expiration: An FTC Study,” the FTC officials seek to overcome delays that “have the potential for abuse” and thus recommend that pharmaceutical companies be limited to only one 30-month stay to block the entry of a generic drug while patent-infringement litigation is underway. Moreover, the officials support pending legislation that would require brand-name companies and first generic applicants to provide copies of certain agreements to the FTC and the Department of Justice for review—a step intended mainly to keep a generic and a “branded” company from blocking other would-be competitors from marketing the branded company's product when its patent expires. Commenting on the pending legislation referred to in the FTC report, Carl Feldbaum, president of the Biotechnology Industry Organization (BIO; Washington, DC), says that, if enacted, it “would topple the delicate balance within the prescription drug–patent system, which, since the 1984 Hatch-Waxman Act, has helped speed the approval of generic drugs while maintaining the market incentives for innovators.” JLF
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