February 27, 2006

GlaxoSmithKline (GSK) has filed a lawsuit against the FDA to block sales of generic versions of its allergy nasal spray Flonase. The suit claims the agency has not established how to determine bioequivalence for nasal sprays.

The lawsuit, filed in the U.S. District Court for the District of Maryland, comes one day after the FDA approved Boehringer Ingelheim GmbH's version of Flonase (fluticasone propionate).

The court issued a temporary restraining order on the marketing of generic Flonase, as well as any subsequent FDA approvals, until 2 p.m. on March 6. Boehringer Ingelheim's Columbus, Ohio-based subsidiary Roxane Laboratories was selling the generic version of Flonase.

The stay also orders GSK and its authorized generic distributor Par Pharmaceutical to stop distributing GSK's generic Flonase product, and prohibits GSK from contracting with another company to distribute a version of the product.

GSK's lawsuit contends the FDA approved generic Flonase without establishing that it works the same way as the brand product. The FDA's decision to approve the generic product was made before the agency "established a scientifically valid methodology for assessing the bioequivalence" of nasal sprays as required by the Food, Drug and Cosmetic Act (FDCA), according to the GSK suit.

The FDA has worked since 1999 to establish bioequivalence for nasal sprays, and has issued two draft documents but no final guidance. In May 2004, after several generic companies filed abbreviated new drug applications (ANDAs) to market generic versions of Flonase, GSK submitted a citizen petition to the FDA asking the agency to issue a "complete and final" bioequivalence method for nasal spray products.

GSK also says the FDA did not require Boehringer Ingelheim's product to meet the same quality standards as Flonase. GSK claims that the FDA approved the generic product "without requiring a consistent level of quality of all similarly situated products," as required by the FDA and the federal Administrative Procedure Act. GSK said it had to redesign its Flonase nasal spray device to address what the FDA said were "deficiencies" in droplet size distribution and spray pattern.

GSK also complained that the FDA did not give GSK notice before approving the ANDA for Flonase. In March 2005, GSK submitted a citizen petition asking for three days' notice if the FDA denied GSK's petitions and approved any ANDAs from generic companies for Flonase.

The lawsuit comes on the heels of a recent industry conference in which a top FDA official asked the generic drug industry to "work together" with the FDA to develop bioequivalence methods and standards for nasal sprays and other products.