Experts in Technical Area (FDA) Caution Supreme Court About Problems in Overruling Chevron Deference (1/12/24)

I recently wrote a blog on the bad effects of eliminating Chevron deference in a specific context—the § 6751(b) regulations bringing clarity to the legal mess created by the courts. Musings on Proposed § 6751(b) Regulations and the Potential Demise of Chevron Deference (Federal Tax Procedure Blog 1/8/24; 1/15/24), here. A team of multi-disciplinary authors has published a similar blog relating to the Federal Drug Administration (“FDA”). Nikhil Chaudhry, Reshma Ramachandran, & Joseph Ross, Overruling Chevron and FDA Decision-Making (Yale J. on Reg.: Notice & Comment 2/9/24), here. The authors credentials are:

Nikhil Chaudhry is a Postgraduate Associate at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency. Dr. Reshma Ramachandran is an Assistant Professor of Medicine at the Yale School of Medicine and Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency. Dr. Joseph Ross is a Professor of Medicine at the Yale School of Medicine, Professor of Public Health at the Yale School of Public Health, and Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency.

The authors make essentially the same point I made—abandoning Chevron in technical areas, like tax and the FDA, so that judges rather than experts make key interpretations will (quoting the Conclusion):

Overruling Chevron would drastically increase uncertainty and make public health agencies like the FDA less predictable and less effective. There is a high likelihood that decades of precedent would be undone by individual challenges to regulatory decisions, leading to great disorder—for Congress, for the agency, and for physicians and patients across the United States. The highest court should at the very least create a carve out for deference to scientific agencies, although it’s unclear how this would be operationalized. Regardless of how this court decides, with an array of complex public health and medical decisions arising in the 21st century, we need an effective government and more regulatory oversight, not less.

Among these authors’ arguments is the following:

The Federal Food, Drug, and Cosmetic Act is the prime example of a complex statute that requires delegation to the expert agency, and the Chevron opinion was explicitly written with an understanding that certain agencies fundamentally regulate based on their technical expertise. Most Article III courts lack the necessary expertise to make precedent-setting public health decisions, as judges have wisely acknowledged by utilizing Chevron in lower court cases challenging the FDA. Abandoning Chevron would be abandoning a doctrine of humility as Justice Kagan described in oral argument.

Practicing so called “armchair epidemiology” would essentially be interpreting the technical nature of the FDCA, regulating public health without any scientific expertise. This is clearly out of reach for many courts as demonstrated in Otsuka Pharm. Co v. Price, where courts were found to be not competent to evaluate if “a company created a new ‘active moiety’ by joining a previously approved moiety to lysine through a non-ester covalent bond.” Similarly, as show in the Mylan Laby’s, Inc. v. Thompson opinion in the D.C. Circuit, there is an inherent complexity in the “evaluation of scientific data,” outlining the necessity of interpreting “statutory phrase[s]… in the context of the kind of drug at issue.” The FDA is responsible for developing scientifically sound solutions to complex public health problems, where the understanding of a given medical product and the context of the problem are constantly in flux.

The last paragraph’s discussion of moiety reminded me of discussions of active moiety at oral arguments and then in the opinion in Kisor v. Willkie, 589 U.S. ___, 139 S. Ct. 2400 (2019)l. I discuss the Kisor oral argument and opinion on moieties in Even More on Skidmore (Including Equipoise as to Interpretation)(Federal Tax Procedure Blog 7/7/19), here. Readers wanting to consider how the Supreme Court might address the moiety question (and technical issues like it) in considering whether to abandon Chevron.