ELR Citation: 42 ELR 20073
No(s). 11 civ. 3562 (S.D.N.Y. Mar 22, 2012) (Katz, MJ)

A district court held that the FDA must reconsider its approval of certain antibiotics used in animal feed unless, after a hearing, the drug uses at issue are determined to be safe. In 1977, the FDA issued notices of an opportunity for hearing (NOOHs) on proposals to withdraw penicillin and tetracycline in animal feed. In December 2011, the FDA withdrew the NOOHs on the ground that they were outdated. Environmental and citizens groups filed suit, alleging that the FDA's failure to withdraw approval of the antibiotics following its 1977 NOOHs constituted an agency action unlawfully withheld or unreasonably delayed in violation of the APA. The court agreed. Based on the text of §360b(e)(1) of the Food, Drug, and Cosmetic Act, as well as the structure of §360b as a whole, the FDA Secretary must issue a notice and an opportunity for a hearing whenever he finds that a new animal drug is not shown to be safe. If the drug sponsor does not meet her burden of demonstrating that the drug is safe at the hearing, the FDA must issue an order withdrawing approval of the drug. Here, in both the penicillin and the tetracycline NOOHs, the FDA explicitly concluded that the drugs had not been shown to be safe. Such a conclusion is the statutory trigger for the FDA to institute withdrawal proceedings. Accordingly, the FDA must hold the requested hearings and withdraw approval if the drug sponsors fail to show that the drugs are safe. The FDA argued that the groups' claim is moot because it rescinded the NOOHs in 2011. But because the FDA's rescission of the 1977 NOOHs did not rescind the original findings that the use of penicillin and tetracycline in animal feed has not been shown to be safe, the groups' claim is not moot.