From dem AG’s amici brief in Louisiana v. FDA re: Purcell -
“Mifepristone's safety record is so conclusive that leading medical associations, as well as
several amici, have advocated that the FDA's Risk Evaluation and Mitigation Strategy (REMS) designation for the drug be eliminated altogether, viewing it as outdated and medically unjustified."
And in October 2025, a federal district court in Hawaii held that the FDA's decision to retain certain prescribing and dispensation restrictions on mifepristone was arbitrary and capricious
because of the overwhelming record of the drug's safety and efficacy, and remanded to the agency without vacatur for a new analysis. See Purcell v. Kennedy, No. 1:17-cv-493, 2025 WL 3101785,
at *2 (D. Haw. Oct. 30, 2025).
First few pages of Purcell v. Kennedy
Purcell v. Kennedy, No. 1:17-cv-493, 2025 WL 3101785 (D. Haw. Oct. 30, 2025).
Case 1:17-cv-00493-JAO-RT
Document 253
PageID.9606
Filed 10/30/25 Page 1 of 79
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF HAWAII
HEIDI PURCELL, ET AL.,
Plaintiffs,
VS.
ROBERT F. KENNEDY, JR., in his official capacity as SECRETARY, U.S.
D.H.H.S., ET AL.,
CIV. NO. 17-00493 JAO-RT ORDER GRANTING PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT (ECF NO. 221) AND DENYING DEFENDANTS' CROSS MOTION FOR SUMMARY JUDGMENT (ECF NO. 228)
Defendants.
ORDER GRANTING PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT (ECF NO. 221) AND DENYING DEFENDANTS' CROSS
MOTION FOR SUMMARY JUDGMENT (ECF NO. 228)
The Food and Drug Administration ("FDA" or "Agency") regulates
prescription drugs to ensure their safe use. When approving drugs, the Agency sometimes requires a "risk evaluation and mitigation strategy" ("REMS") if it determines such a strategy "is necessary to ensure that the benefits of the drug outweigh the risks of the drug." 21 U.S.C. §§ 355-1(a)(1). In addition, when imposing a REMS, the FDA may further restrict the drug by imposing certain
"elements as are necessary to assure safe use" ("ETASU"). Id. § 355-1(f).
ETASUs must "be commensurate with the specific serious risk listed in the labeling of the drug" and cannot "be unduly burdensome on patient access to the
Case 1:17-cv-00493-JAO-RT Document 253
PageID.9607
Filed 10/30/25 Page 2 of 79
drug," especially considering "patients who have difficulty accessing health care (such as patients in rural or medically underserved areas)[J" Id. § 355-1(f)(2)(A),
(C).
This case involves a challenge to the FDA's regulation of mifepristone, a
drug used as part of a regimen for medication abortion. Mifepristone is one of
Purcell v. Kennedy, No. 1:17-cv-493, 2025 WL 3101785 (D. Haw. Oct. 30, 2025) 2-3
Importantly, Purcell does NOT support Liz Murrill. The REMS are arbitrary and capricious because mifepristone is TOO SAFE FOR SUCH RESTRICTIVE TREATMENT
Ultimately, the Court concludes that the Agency violated the APA by failing
to provide a reasoned explanation for its restrictive treatment of the drug, which
was compounded by its decision to limit the scope of information it considered when evaluating the REMS. More specifically, the Agency neglected to consider certain required statutory factors and generally failed to sufficiently explain the
logic behind any reasoning it did provide, rendering the 2023 REMS Decision
arbitrary and capricious.
Purcell v. Kennedy, No. 1:17-cv-493, 2025 WL 3101785 (D. Haw. Oct. 30, 2025)
merits. Any other court has decided on procedural grounds.
2. The ONE court, #HI in #Purcell v. Kennedy, found the REMS arbitrary and capricious in a WIN for #abortion rights, contrary to Murrill’s reasoning; the real reason undermines Murrill’s statement. Mifepristone is TOO safe for the REMS. ⬇️