By Guest Contributor Diana R. H. Winters
Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts. The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.
With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public. In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed. This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general. The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.
FDA first called for these withdrawal hearings in 1977, but never held them. The notices for hearing stated that the drugs were no longer “safe under the conditions of use prescribed, recommended, or suggested in their labeling.” So, why weren’t the hearings held? Various reasons. More studies were needed, Congress basically told them not to, there were other priorities, hearings take a long time, and et cetera. In 1999 and 2005, various advocacy organizations petitioned FDA to withdraw the approval for these drugs. FDA did not answer either of these petitions.
In 2011, a group of public interest organizations sued FDA, arguing that the Food Drug and Cosmetic Act (FDCA) required the agency to hold the hearings that it had called for in 1977, and also that FDA had unreasonably delayed answering the petitions filed in 1999 and 2005. During the suit, FDA denied the petitions and petitioners supplemented their complaint with an allegation that the denials were arbitrary and capricious. In 2012, a district court granted plaintiffs’ motions for summary judgment on both claims. This was an unusually strongly worded opinion. The judge wrote that “ 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.”
Yesterday, the Second Circuit reversed the district court on both counts.
The principal question in this case is one of statutory interpretation. The withdrawal of approval for animal drugs is governed by 21 U.S.C. § 360b(e)(1), which states, “[t]he Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application . . . if the Secretary finds . . . that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application as approved.” The issues here are whether FDA was obligated to proceed with hearing, once it had found the animal drugs to be unsafe, and what exactly this finding had to entail. Both sides agreed that the statutory language was ambiguous.
FDA argued that even though it had stated in its 1977 notice for a hearing that these drugs were not safe under the conditions of their use, it had never made a “finding,” because it had never held the hearing, and it did not need to do so. Plaintiffs argued, to the contrary, that once FDA had “found” the drugs to be unsafe in the notice for a hearing, the agency was required to hold that hearing and move forward on the withdrawal. Notably, plaintiffs did not argue that the statute required the withdrawal of approval for the drugs, merely a hearing.
This was not a case of Chevron deference because FDA had not issued a definitive interpretation of § 360b(e)(1), but the Second Circuit nevertheless was persuaded by FDA’s interpretation. Looking at the statutory text, the court found that plaintiffs’ interpretation “requires not one but two findings, in a sentence that refers to only one.” The majority then goes on to find that this interpretation comports with the provision’s context and background legal concepts.
We see here an example of the “crabbed” style of statutory interpretation that commentators, like Nicole Huberfeld and Nicholas Bagley, have accused the Halbig court of using. As the dissent in NRDC v. EPA explained, any reading of the provision in its larger context would show that once FDA had made a preliminary finding that the drugs were unsafe, it was required to hold hearings on their withdrawal. The plaintiffs’ argument was the better one: because the primary purpose of the FDCA is to protect the public; because the statute’s provisions regarding human drugs have always been construed to assume that withdrawal hearings would follow a preliminary finding; and because administrative practice comports with this sequence of events. Yes, it would be better if Congress had written a clearer statute. But because it didn’t, the court should, as the dissent argues, “do our best to determine which of these … meanings Congress intended to convey.”