FDA After Loper Bright

Abstract

This Article illustrates that Loper Bright may empower the U.S. Food and Drug Administration in unexpected ways. 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. This Article grapples with the effect of the decision at FDA — one of the most important federal agencies, affecting the life of every person in the United States and regulating about a quarter of all consumer spending in the country, i.e., over $4 trillion annually. It makes three novel and potentially surprising claims, as follows.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