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THE GREATER Access to Affordable Pharmaceuticals Act (GAAP), passed by the Senate in July, limits the number of automatic 30-month stays to one, consistent with a recommendation in a recent Federal Trade Commission (FTC) report (C&EN, Aug. 5, page 11). Innovator drug companies vigorously opposed this provision on the basis that it undermines intellectual property protection. But according to Michael S. Wroblewski, FTC assistant general counsel for policy studies, "The 30-month stay is in addition to the ability of the brand-name company to sue. What we're saying is eliminate the ability to block FDA action so FDA can then approve, for example, generic Paxil. Companies can still litigate."
According to the FTC study, even with approved ANDAs, generic companies usually do not market drugs that are still the subject of lawsuits.
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