Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2168 Page 7 of 31
PubMed and Embase and those provided by “advocacy groups, individuals, plaintiffs in Chelius v. Becerra, 1:17-493-JAO-RT (D. Haw.), application holders, and healthcare providers and researchers. Id. at 10–11.
On December 16, 2021, FDA announced its conclusions regarding the Mifepristone REMS Program. ECF No. 51-5. On January 3, 2023, FDA accepted these conclusions by approving the supplemental applications proposing conforming modifications. ECF Nos. 51-8; 51-11. The 2023 REMS removed the in-person dispensing requirement and added a pharmacy-certification requirement. ECF Nos. 51-4, 51-5. The FDA maintained the Prescriber and Patient Agreement Form requirements. Id.
DISCUSSION
- I. Preliminary Injunction Standard
Plaintiffs, on behalf of themselves and as parens patriae in protecting the health and well-being of its residents, moves for a preliminary injunction “affirming FDA’s original conclusion that mifepristone is safe and effective, preserving the status quo by enjoining any actions by Defendants to remove this critical drug from the market, and enjoining the unnecessary and burdensome January 2023 restrictions.” See ECF Nos. 3 at 5; 35.
Pursuant to Federal Rule of Civil Procedure 65, the Court may grant preliminary injunctive relief in order to prevent “immediate and irreparable
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 7
