Public Citizen Sues FDA Seeking Action on Petition to Ban Serzone

WASHINGTON - Consumer watchdog Public Citizen sued the U.S. Food and Drug Administration March 15, claiming that the agency's failure to act on its petitions to withdraw Serzone violates the Administrative Procedures Act (APA). Public Citizen, Inc. v. Food and Drug Administration, No. n/a (D. D.C.).

In its complaint, Public Citizen seeks a court order requiring the federal agency to issue a decision on the petition within 30 days after it is determined whether the FDA's actions are unlawful.

Serzone received FDA approval in December 1994, and was prescribed to nearly 2.8 million Americans in 2002. But liver toxicity …