FDA Wins Federal Appeals Court Case on Authorized Generics
Brand drugmakers have won another victory on the authorized generics front, as a federal appeals court ruled that federal law does not prohibit the holder of an approved new drug application (NDA) from marketing its own "brand-generic" version of the product during the 180-day exclusivity period afforded to generic firms.
The ruling by the U.S. District Court of Appeals for the District of Columbia came in response to an appeal filed by generic drugmaker Teva Pharmaceutical, which was seeking to overturn a lower court ruling in its closely watched authorized generics lawsuit against the FDA. Teva sued the FDA last August after the agency rejected its citizen petition requesting that Pfizer be prohibited from launching an authorized generic version of Neurontin (gabapentin), for which Teva was awarded marketing exclusivity as the first generic firm to file an abbreviated new drug application (ANDA).
In late December 2004, U.S. District Court for the District of Columbia Judge Reggie Walton sided with the FDA, ruling the agency acted in accordance with federal law when it rejected Teva's petition. Specifically, Walton said federal law only prohibits the FDA from approving subsequent ANDAs until after the 180-day exclusivity period has expired. Authorized generics are launched under the brand firm's NDA and, therefore, aren't subject to the marketing exclusivity rules created by the Hatch-Waxman Act, Walton concluded.
Although, Teva conceded that nothing in Hatch-Waxman expressly prohibits a brand firm from marketing an authorized generic, it urged the appeals court to adopt a "functional" interpretation of the marketing exclusivity provision, arguing that Congress' intent when it passed Hatch-Waxman was to give the first ANDA filer complete exclusivity in the generic market for 180 days.
The appeals court, however, soundly rejected that argument and affirmed Walton's December ruling. Hatch-Waxman "says nothing about how the holder of an approved NDA may market its drug," states the appeals court.
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