FDA appeals judge's order to take action on antimicrobial use

The U.S. Food and Drug Administration (FDA) has appealed a mandate ordering the agency to move forward with its 1977 proposal to address concerns related to subtherapeutic use of antimicrobials in food animals. A federal district court judge in New York issued the orders on March 22 in response to a lawsuit filed by the Center for Science in Public Interest, National Resources Defense Council, the Union of Concerned Scientists and Food Animal Concerns Trust. The four organizations claim that the FDA failed to deliver on its promise to conduct proceedings to withdraw approvals for subtherapeutic uses of penicillin and tetracycline.

The appeal, dated May 21, is filed by Margaret Hamburg, commissioner, of the FDA; Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine; and Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services.

If the FDA fails to overturn the court’s ruling, the agency will be required to initiate withdrawal proceedings for relevant NADAs (new animal drug applications) and ANADAs (abbreviated new animal drug applications). Additionally, it will need to reissue a notice of the proposed withdrawals, which may be updated, and provide opportunities for hearings to drug sponsors.