ELR Citation: 44 ELR 20174
No(s). 12-2106, -3607 (2d Cir. Jul 24, 2014)

The Second Circuit reversed a lower court decision that FDA was required to hold hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed. Looking at the text of the Federal Food, Drug, and Cosmetic Act, the context, the regulations, and the background legal principles, the court concluded that Congress has not required FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage. In addition, FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs by issuing or withdrawing notice of opportunities of hearings. Further, the statutory mandate contained in 21 U.S.C. §360b(e)(1) applies to limit FDA's remedial discretion by requiring withdrawal of approval of animal drugs or particular uses of such drugs only when FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety. The court also held that the decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary determination left to FDA. And based on the record in this case, FDA's decision denying two citizen petitions urging it to hold hearings to determine whether to withdraw its approval of the use of penicillin and tetracyclines in animal feed was neither arbitrary nor capricious.