Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2166 Page 5 of 31
In 2015, Mifeprex’s manufacturer submitted a supplemental NDA proposing to update the label to reflect evidence-based practices across the country – namely, the use of 200 mg of mifepristone instead of 600 mg. Id., ¶ 92. In July 2015, the manufacturer submitted its REMS assessment, proposing minor modifications. Id. This submission prompted a review of the Mifeprex label and REMS by FDA. Id. at 26, ¶ 93. As part of the review, FDA received letters from more than 40 medical experts, researches, advocacy groups, and professional associations who asked, inter alia, that the REMS be eliminated in their entirety. Id. One letter asked FDA to “[e]liminate the REMS and ETASU (Elements to Assure Safe Use), including eliminating the certification and patient agreement requirements. Id. at 27, ¶ 95.
In 2016, FDA found “no new safety concerns have arisen in recent years, and that the known serious risks occur rarely,” and that “[g]iven that the number of … adverse events appear to be stable or decreased over time, it is likely that … serious adverse events will remain acceptably low.” Id. at 30, ¶ 100. Following this review, FDA changed Mifeprex’s indication, labeling, and REMS, including increasing the gestational age limit from 49 to 70 days, reducing the number of required in-person clinic visits to one, finding at-home administration of misoprostol safe, finding no significant differences in outcomes based on whether patients had a follow-up phone call or in person or based on the timing of those appointments, and allowing a broader set of healthcare providers to prescribe
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 5
