COURT RULES AGAINST TEVA ON AUTHORIZED GENERICS

In a recent court decision that indicates authorized generics may be here to stay, Judge Reggie Walton of the U.S. District Court for the District of Columbia denied Teva Pharmaceutical's motion for summary judgment in a lawsuit the generic drugmaker filed against the FDA.

Filed by Teva in August 2004, the suit alleged that the FDA's position allowing authorized generics is arbitrary, capricious and violates federal law. Teva asked the court to overturn a July 2004 mandate in which the FDA denied citizen's petitions submitted by Teva and Mylan Pharmaceuticals seeking to prohibit the marketing of authorized generic drugs during another generic firm's 180-day exclusivity period.

According to Teva, if brand generic drugs, or authorized generics, are allowed to enter the market during another generic company's exclusivity period, this action would diminish the incentive for abbreviated new drug application (ANDA) seekers to undertake the expensive paragraph IV certification process, the court's decision states.

The FDA countered that it has no "statutory authority to delay the entry into the market of brand generic drugs." In addition, the FDA stated that its decision not to grant Teva's citizen's petition was not "inconsistent with prior FDA decisions and thus a remand is not appropriate."

Walton sided with the FDA in a late December 2004 ruling, concluding that the agency acted in accordance with federal law when it rejected the petitions. Specifically, Walton ruled that federal law "only prohibits the FDA from approving subsequent ANDAs until after the 180 day exclusivity period has expired. Nothing in the statute provides any support for the argument that the FDA can prohibit [new drug application] holders from entering the market with a brand generic drug during the exclusivity period."