FDA Not Required to Hold Hearings on Antibiotics Bans, Second Circuit Says
The Second Circuit has reversed a district court’s decision that ordered the U.S. Food and Drug Administration (FDA) to initiate hearings responding to a livestock antibiotics challenge from the Natural Resources Defense Council (NRDC) based on a 1977 agency finding that the use of growth antibiotics for healthy animals was unsafe. NRDC v. FDA, No. 12-2106 (2d Cir., order entered July 24, 2014). Two judges were “firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage,” that FDA has discretion on proceedings to withdraw approval of animal drugs, and that the law requires “withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety.”
In 1977, FDA planned to limit the use of growth antibiotics in animals by pulling them from the market, but following the agency’s formal rejection of the plan in 2011, environmental groups sued FDA to force the implementation of the plan. Agreeing with the groups, as led by NRDC, a district court ordered FDA to initiate hearings on the controversial use of antibiotics. Additional information about the district court’s ruling appears in Issue 432 of this Update.
In reversing the district court, the Second Circuit held that the lower court could not force FDA to restart its plan because FDA has discretion on when it holds hearings or begins the process of withdrawing approval for the drugs. In addition, the 1977 FDA conclusion about the use as unsafe does not bind the agency to pursue the withdrawal of approval because the conclusion was not a final determination.
In a dissent, the chief judge warned, “Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug. It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug.”
