FDA After Loper Bright

Loper Bright Enterprises v. Raimondo, which overruled the Chevron, U.S.A. v. Natural Resources Defense Council decision from 1984, tells us that a court should determine the meaning of all statutory provisions for itself, rather than deferring to the views of the federal agencies that implement those provisions. But the overruling of Chevron may have less of an impact on the U.S. Food and Drug Administration (FDA) than conventional wisdom supposes. Most challenges to FDA action do not concern its statutory interpretations. And the agency prevailed in most cases involving statutory interpretation before the Chevron doctrine took hold. After 1984, when the doctrine did apply, the agency often lost cases at “step one” of the analysis because the statute clearly foreclosed the agency’s reading. If anything, FDA may have fared worse in the Chevron era. To be sure, de novo review of FDA’s statutory interpretations could yield some surprises. Some of FDA’s statutory interpretations are half a century old, or older, and experts in the field have internalized them, without realizing that federal judges coming to the issues cold may see things differently. Still, alarm about de novo review is premature. Regulated parties may decline to upset the apple cart, and the Court’s standing jurisprudence may limit the others who would seek to do so. Although overruling Chevron may have only a modest impact, this Article explains that the Loper Bright decision, in a different way, may indeed have a significant impact. The decision—and the formalist principles the Court has embraced—provides a clear path forward for FDA and other agencies to prevail in judicial challenges. Specifically, the majority opinion permits a simplified taxonomy of agency actions and their corresponding scopes of review, under which much of the agency’s work would receive deferential review in federal court—because the agency was not interpreting its statute. Instead, it was engaged in policymaking or exercising discretion pursuant to clear legislative authorization. Consequently, concerns that the Loper Bright decision will hamstring FDA are overblown. The agency may be resilient. This Article illustrates how it could defend itself and may thus offer ideas for other agencies that face challenges in the new era.