Does the Mifepristone Case Tee Up a Chevron Challenge?

In Alliance for Hippocratic Medicine v. USFDA, U.S. District Judge Matthew J. Kasmaryck stayed the FDA approval of the abortion drug Mifepristone, disregarding the FDA's medical and scientific judgment to approve the drug 23 years ago and decades of clinical data affirming the drug's safety and efficacy.[1] The judge afforded no deference to FDA's expertise and, instead, felt free to substitute his own judgment and that of the plaintiffs' experts. What does that imply for the doctrine of deference laid down in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 468 U.S. 837 (1984)?

We do not dwell in this post on what appear to be fatal problems with standing and timeliness of the plaintiffs. Nor do we address here that the order appears wholly informed by the judge's religious objections to abortion, rather than law or science. It's the court's treatment of the merits, i.e., that FDA lacked sufficient data to support the drug in the first place, that should be of critical interest to environmental lawyers.

Although Chevron was mentioned in neither the District Court nor the 5th Circuit's order, which mostly affirmed the lower court, the case is now before the Supreme Court. It seems most likely that the Court will dispose of the case on standing or other procedural grounds and thus avoid the merits. However, the high Court has long been signaling its impatience with Chevron deference, and we wonder if it will seize on this opportunity to pare back this central element of environmental administrative law.

What is now well known as Chevron deference refers to the doctrine of judicial deference given to agency actions. In Chevron, the Supreme Court provided a test for when courts should defer to an agency's interpretation of a statute it is responsible for enforcing: in short, if the statute is silent on the issue or the statutory language is ambiguous, the agency's statutory interpretation is not unreasonable, and Congress has not otherwise directly answered the question, deference to the agency's interpretation is appropriate. As Justice Stevens explained, when the statute is silent or ambiguous, the court may not substitute its own interpretation of the statute if the agency action was based on a permissible construction of that statute.

Chevron deference became a staple of environmental law practice in the U.S. over the years and a key consideration for any attorney thinking of questioning an agency's interpretation. But in recent years, Chevron has come under attack from state courts and the Supreme Court, as well as being a regular target of some conservatives wanting to curb agencies' power.

Ohio recently concluded that state courts do not have to defer to state agency interpretations of state law in TWISM Ents., L.L.C. v. State Bd. Of Registration for Professional Engineers & Surveyors, Slip. Opinion No. 2022-Ohio-4677. In 2021, the 6th Circuit held in Gun Owners of America v. Garland, No. 1901298 (6^th Cir. 2021), that an agency's interpretation of a criminal statute is not entitled to Chevron deference. Justice Kavanaugh did not even mention Chevron when rejecting the U.S. Department of Health and Human Services' change to its method of calculating reimbursement rates for hospitals providing prescription drugs, focusing instead on "traditional tools of statutory interpretation."

The high-profile West Virginia v. EPA decision and the newly announced "major question doctrine" further stripped Chevron of its influence when reviewing administrative actions with transformative effects, such as actions with significant economic or political impact.

These are only a few examples of Chevron's dwindling influence on administrative law. The Supreme Court would not need to rely on Chevron if it decides to uphold Judge Kasmaryck's decision on Mifepristone. Denying the drug to women across the country, even those who reside in states in which abortion is legal, would certainly qualify as a major question. But the notion that agencies must have sufficient discretion to reasonably rely on data to support an agency decision is essential to the administrative process. Courts have always been reluctant to substitute their own judgment for that of government experts, and the far-reaching implications of upholding the Kasmaryck's decision is an apt example of the wisdom of that approach.

*Rick Glick is a former partner at Davis Wright Tremaine with decades of experience in environmental law and is recently retired.