Washington v. U.S. Food and Drug Administration
Washington v. U.S. Food and Drug Administration (E.D. Wash, Apr. 7, 2023): A second District Court decision was issued on April 7, 2022, in the Eastern District of Washington, further convoluting the status of mifepristone in the United States. District Court Judge Thomas O. Rice’s decision blocking the FDA from altering its mifepristone control program was issued just minutes after Judge Kacsmaryk issued his decision. At the heart of the case is the FDA’s 2023 Risk Evaluation and Mitigation Strategy (REMS) for mifepristone; REMS programs are generally used for drugs “with serious safety concerns.” The updated 2023 REMS for mifepristone allowed retail pharmacies to become certified to dispense mifepristone and removed a requirement that it be dispensed in-person, among other modifications.
On February 24, 2023, seventeen states and the District of Columbia sought an order from the court prohibiting the FDA from “enforcing or applying the 2023 REMS” and further prohibiting the agency from limiting the availability of mifepristone or removing it from the market. The plaintiffs argued that the FDA violated the Federal Food, Drug, and Cosmetic Act (FDCA) by issuing the 2023 REMS because mifepristone does not meet the statutory definition of a drug that requires a REMS or the more restrictive Elements to Assure Safe Use (ETASU).
Judge Rice granted plaintiffs’ motion in part, finding that the plaintiffs were likely to succeed because “FDA did not assess whether mifepristone qualifies for REMS and ETASU based on the criteria set forth under” the FDCA in likely violation of the Administrative Procedures Act. Judge Rice also noted that the FDA presented “potentially internally inconsistent…findings regarding mifepristone’s safety profile.” Judge Rice cited multiple scientific studies on the safety and efficacy of mifepristone, in the United States and abroad, as well as the drug’s use in the treatment of Cushing’s disease. Although the plaintiffs requested a nationwide order, Judge Rice limited his order to the plaintiff jurisdictions, blocking the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy.” Read the full decision here.
On April 10, 2023, the Defendants filed a Motion for Clarification, requesting that the Court clarify the FDA’s obligations in light of the Alliance for Hippocratic Medicine decision.