FDA Finalizes Rules to Speed Generics to Market

OCTOBER 01, 2003

    Final new rules issued by the FDA are expected to speed the approval of generic drugs and to produce billions of dollars in savings for consumers of prescription medicines. The new rule limits the number of automatic 30-month stays that may delay generic drug availability and clarifies the types of drug patents that can be submitted for listing in the Orange Book?FDA?s source for each drug?s applicable patents.

    According to FDA officials, these changes ?will prevent innovator drug companies from submitting certain new patent claims that are unlikely to represent substantial new innovation in order to extend their marketing protection, thus delaying the approval of a generic equivalent.?

    The new rules are only 1 step in a broader campaign by the FDA to help bring lower cost generics to the market sooner. Agency officials pledged to ?continue to make the generic drug approval process more efficient with the goal of lowering national health care costs by reducing the cost of bringing safe and effective generic drugs to market.?


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