ANDRX FILES CITIZEN'S PETITION OVER AUTHORIZED GENERICS

Andrx Pharmaceuticals has filed a citizen's petition with the FDA requesting that the agency seek the advice of the FTC and the Justice Department on the contentious issue of authorized generics.

The petition represents a new approach to the authorized generics fight by the generics industry, which up until now has attacked the FDA in court, arguing that the agency's position allowing authorized generics is arbitrary, capricious and violates federal law.

Filed late last month, Andrx's petition requests that the agency seek comments from the FTC's Bureaus of Competition and Consumer Protection, and from Justice's Antitrust Division "on the potential short- and long-term effects of the marketing of authorized generics on consumers, generic drug producers, and competition ... [since] FDA has acknowledged that it lacks expertise in matters of competition."

In July 2004, the FDA denied citizen's petitions filed by Mylan Pharmaceuticals and Teva Pharmacutical that asked the FDA to prohibit the marketing of authorized generic drugs during another generic firm's 180-day exclusivity period.

Andrx's petition, however, states that the agency does not have the expertise needed to make determinations on matters of competition involving authorized generics.