A federal magistrate judge in New York has determined that the Food and Drug Administration (FDA) must begin proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes on the agency’s timeline, thus denying FDA’s request for a stay while the matter is pending on appeal before the Second Circuit. NRDC v. FDA, No. 11 Civ. 3562 (JCF) (U.S. Dist. Ct., S.D.N.Y., decided August 8, 2012). In June, the court determined that FDA arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of these proceedings. More information about the case appears in Issue 442 of this Update.
The magistrate first ruled on the Natural Resource Defense Council’s (NRDC’s) motion to strike a document from the record; it was an Animal Health Institute statement “expressing general support for the FDA’s plans to reduce the non-therapeutic use of medically-important antibiotics in animal feed through a voluntary guidance program.” According to NRDC, the statement was not part of the record before the agency when the challenged decisions were made. The court agreed, further noting that it did not provide any useful background on the issue of whether FDA violated its congressionally mandated duty of initiating withdrawal proceedings 30 years ago when it issued a regulation “providing that the agency would propose to withdraw approval of all [non-therapeutic] uses of antibiotics in animal feed unless drug sponsors and other interested parties” could resolve its growing concern over “the public health risk to humans and animals of antibiotic resistance caused by such uses.”
The magistrate also decided that the plaintiffs had not sufficiently supported their abbreviated timeline for agency action, finding that it was based on unsupported assumptions. While the court rejected the government’s request that no deadlines be imposed, it adopted FDA’s alternative proposed timeline. FDA must issue revised notices of opportunity for public hearing for penicillin and tetracyclines in 17 months, and the agency will have an additional 41 months for the hearing process.
Regarding FDA’s request for stay on the ground that the proceedings would divert significant resources and “compromise FDA’s ability to pursue its goals with respect to antimicrobial resistance and animal drug licensing,” the court noted that the only task on FDA’s schedule during the pendency of the appeal “is the beginning of the literature review—an entirely internal process which, even if ‘resource-intensive’ is hardly likely to infringe significantly on the FDA’s operations.” The court also commented that FDA’s insistence that its voluntary program will succeed lacked any support in the record. Thus, “engaging in the mandated withdrawal procedures promptly will allow drug sponsors the opportunity to show that the challenged drug uses are safe.”