A federal court in New York has determined that the Food and Drug Administration (FDA) arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of proceedings to withdraw approval from certain uses of antibiotic drugs in livestock. Natural Resources Defense Council v. FDA, No. 11 Civ. 3562 (THK) (U.S. Dist. Ct., S.D.N.Y., decided June 1, 2012). The ruling follows the court’s March 2012 grant of summary judgment to the plaintiffs on their first claim for relief. Additional information about that ruling appears in Issue 432 of this Update. The most recent ruling relates to the third claim for relief, that is, whether FDA violated the Administrative Procedure Act when it denied the two petitions “requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals.”
The court first determined that it had subject matter jurisdiction over the claim, disagreeing with FDA’s assertion that its November 2011 decision to deny both petitions was a matter for agency discretion, not subject to judicial review. On the merits, the court found that FDA repeatedly turned aside requests for agency considerations of antibiotic safety by asserting that such reviews would be time-consuming and resource intensive and that better results would be obtained with voluntary industry action under several agency guidances. According to the court, the Food, Drug, and Cosmetic Act “contains no language indicating that the costs of a withdrawal proceeding— either to the Agency itself or to industry—are to be taken into account when making the decision whether to initiate withdrawal proceedings. Rather, in both approving an initial drug application and determining whether withdrawal is appropriate, the inquiry focuses on whether the drug is safe and effective.”
Noting that the agency had neither considered nor addressed the thousands of pages of scientific evidence submitted in support of the petitions relating to the propensity for sub-therapeutic uses of antibiotics in livestock to promote antibiotic-resistant bacteria and the increase in antibiotic-resistant bacteria in humans, the court said, “FDA in refusing to follow the statutory mandate of withdrawal proceedings” and “[d]enying the Petitions on the grounds that it would be too time consuming and resource-intensive to evaluate each individual drug’s safety, and withdraw approval if a drug was not shown to be safe, is arbitrary and capricious.” The court also noted that the petitions had been pending for 13 and seven years, respectively, thus, “The position that instituting withdrawal proceedings—what the statute mandates—is too time consuming is both ironic and arbitrary.”
The court further observed, “For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks.” Without compelling FDA to reach a certain conclusion, the court remanded the matter for further proceedings. The agency appealed the court’s March ruling to the Second Circuit Court of Appeals on May 21. It is unknown whether FDA will appeal the most recent court ruling.