Document Type
Article
Publication Date
2026
Abstract
Loper Bright, which overruled the Chevron 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 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 challenge in the new era.
First, the Chevron doctrine meant less to FDA than conventional wisdom supposes. Empirical studies of litigation during the Chevron years — one published by the author and one published by a different team — show that FDA often lost cases at “step one” of Chevron, after reviewing courts decided the agency’s statute clearly answered the question differently than the agency had. This Article also offers the first review of litigation against FDA in the decade before Chevron, finding that the agency generally prevailed in cases involving statutory interpretation even without Chevron in play. Indeed, with one possible exception, no case would have clearly come out differently after Chevron, i.e., none that FDA lost and that it unquestionably would have won after 1984.
Second, if Loper Bright and the formalist principles ascendant in the judiciary are understood properly, FDA should now win many cases that it would have won previously on the basis of Chevron deference. But the reasoning will be different. In many of these instances, the agency was not really interpreting its statute. Instead, it was engaged in policymaking. If FDA policymaking was authorized by Congress, judicial review — even after Loper Bright — remains deferential. Thus, some territory that agency defenders fear was lost with elimination of the Chevron framework will be regained if the agency persuades courts of its statutory authority to make discretionary calls. Scouring FDA’s statute for evidence of this authorization has not been a priority in the past, but this Article shows that the search may be surprisingly fruitful.
Finally, de novo review may yield new and surprising results, but not in the cases that people expect. The defeats should not stem from judicial interpretation of ambiguous statutory provisions as to which those courts would previously have deferred to FDA. Again, many of those agency actions should today be understood as policymaking. Instead, the surprises will come when courts review actual interpretations that have not been challenged previously. Some of FDA’s statutory interpretations are half a century old, or older, and experts in the field have simply internalized them, without realizing that federal judges coming to the issues cold will see things very differently. That said, regulated parties may decline to upset the apple cart. And the Court’s increasingly formalist Article III standing jurisprudence may limit the others who would seek to do so.
Scholars and others writing in health law and policy were almost uniformly alarmed by the Loper Bright certiorari grant and have continued to express concern that the decision will hamstring FDA. These concerns were overblown. FDA may be surprisingly resilient. This Article is meant to illustrate how it could defend itself and also offer ideas for other agencies that face challenge in the new era.
Recommended Citation
Erika Lietzan,
FDA After Loper Bright, 79 SMU Law Review
(2026).
Available at: https://scholarship.law.missouri.edu/facpubs/1359