A coalition of non-profit advocacy organizations has filed a complaint for declaratory and injunctive relief against the Food and Drug Administration (FDA), alleging that the agency has unreasonably delayed action on several of its petitions relating to the use of antibiotics in animal feed. Natural Res. Def. Council v. FDA, No. 11-3562 (U.S. Dist. Ct., S.D.N.Y., filed May 25, 2011). The plaintiffs seek orders compelling the agency to “withdraw approval for subtherapeutic uses of penicillin and tetracyclines, unless FDA’s findings are reversed in new administrative proceedings.” According to the complaint, while FDA determined in 1977 that these drugs” have not been shown to be safe,” it never withdrew its approvals for the drugs’ subtherapeutic uses.

Contending that “misuse and overuse of antibiotics has given rise to a growing and dangerous trend of antibiotic resistance,” the coalition alleges that some of its organizations filed citizen petitions in 1999 and 2005 requesting that FDA “withdraw approvals for nontherapeutic uses of antibiotics in livestock if those antibiotics are also important in human medicine.” FDA has apparently never finally acted on either petition. The coalition cites a number of studies purportedly showing that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria in animals and quotes FDA as follows: “[a]ntimicrobial use in animals can contribute to the emergence of antimicrobial resistance which may be transferred to humans, thereby reducing the effectiveness of antimicrobial drugs for treating human disease.”

Alleging violations of the Administrative Procedure Act and the Food and Drug Act, the coalition seeks a declaration that FDA has violated the law and that its delay in responding to the petitions is unreasonable. The coalition also seeks an order compelling FDA to withdraw its approval for the drugs’ uses and to issue a final response to the petitions. The coalition includes the Natural Resources Defense Council, Inc.; Center for Science in the Public Interest; Food Animal Concerns Trust; Public Citizen, Inc.; and Union of Concerned Scientists, Inc.