HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Monday, November 27, 2023

The Conservative Court on the Unacceptable Perils in Second-Guessing FDA Safety Decisions and Its Coming Review of Alliance for Hippocratic Medicine v. FDA (The 'Abortion Pill' Case)

Peter Grossi (Harvard Law School), The Conservative Court on the Unacceptable Perils in Second-Guessing FDA Safety Decisions and Its Coming Review of Alliance for Hippocratic Medicine v. FDA (The 'Abortion Pill' Case), Va. J. Soc. Pol’y & L. (forthcoming 2023):

The August 2023 decision of the Fifth Circuit in Alliance for Hippocratic Medicine v. FDA, 2023 WL 5266026 -- nullifying the critical changes FDA made in 2016 and 2021 to its Risk Evaluation and Mitigation Strategy (REMS) governing the use of mifepristone (the abortion medication used by hundreds of thousands of American women each year)--sets up perhaps the most important Supreme Court review of any judicial ruling on an action by FDA or any other agency. The stakes are huge. If not reversed by the Supreme Court, the Fifth Circuit's ruling will severely restrict access to mifepristone, not only to women living in the 17 states that effectively ban abortion within their borders, but also in the 30 or so others which want their residents to have the option of medicated abortion, but whose doctors will be forced to obey restrictions FDA has long determined are both unwarranted and unwise.

When the Justices turn to AHM next year, they should recall a series of decisions in which the Court -- and especially its more conservative members (Justices Roberts, Alito, Kavanaugh and Thomas) -- forcefully warned that no judge or Justice should "second-guess" such scientific judgments that FDA experts make every day with respect to every drug the Agency regulates.. Indeed. the Court applied that rule and repeated that warning only three years ago when it expressly deferred to a judgment FDA had made with respect to the appropriate distribution of mifepristone.  

The Fifth Circuit judges ignored that Supreme Court case law in upending the last seven years of FDA regulation with respect to mifepristone. And they did so without any regard for FDA's reasoned analysis which sought to insure meaningful access to the drug -- one of the specific obligations imposed on FDA by Congress.

This article examines the Supreme Court warnings on the dangers of such judicial second-guessing of FDA drug safety determinations. It then details the history of the modifications FDA made to its mifepristone REMS in 2016 and 2021, (1) extending the deadline for using the drug (from 7 weeks after gestation, which often expired before a woman learned she was pregnant, to a more realistic 10 weeks), and (2) eliminating the requirement of three separate, in-person office visits to obtain and use mifepristone, thus permitting telehealth prescriptions that are now standard with virtually all drugs. 

The article then parses the Fifth Circuit's rulings on those two critical issues, detailing how the panel failed to consider the controlling Supreme Court cases; failed to refute (or even acknowledge_ FDA;s analysis of the relevant scientific and medical data; and overturned the decisions FDA made in 2016 and 2021, while ignoring the new January 2023 REMS which now governs use of the drug.

The article concludes by returning to the individual Justices who authored that contrary "deferential' case law, and assess the likelihood that they will apply those prior opinions in a consistent and intellectually honest manner to reverse the Fifth Circuit's unprecedented intrusion on the authority and expertise of FDA.

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