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Congress, Not Court, Is Place To Change "Authorized" Generic Policy, Judge Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Congress is a better venue for changing FDA's regulation of "authorized" or brand generics, a D.C. Circuit Court of Appeals judge suggests. Teva faces skepticism during oral arguments in its challenge of the agency's refusal to block authorized generics during an ANDA first-filer's 180-day exclusivity.

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FDA’s Policy On “Authorized” Generics Upheld By Appeals Court

Waxman/Hatch provisions barring FDA from approving a later-filed ANDA do not prevent the marketing of generics under an innovator’s NDA during the 180-day exclusive period, the D.C. Circuit Court of Appeals says. The court also rejects Teva’s arguments that FDA should regulate “authorized” generics through supplemental NDAs.

FDA’s Policy On “Authorized” Generics Upheld By Appeals Court

Waxman/Hatch provisions barring FDA from approving a later-filed ANDA do not prevent the marketing of generics under an innovator’s NDA during the 180-day exclusive period, the D.C. Circuit Court of Appeals says. The court also rejects Teva’s arguments that FDA should regulate “authorized” generics through supplemental NDAs.

FTC Should Study Competitive Impact Of "Authorized" Generics, Senators Say

Bipartisan group of senators requests investigation of the short- and long-term competitive impacts of "authorized" generics. Formal study request and remarks by one of the commissioners suggest the generic industry's arguments against the practice are gaining traction on Capitol Hill and at FTC.

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