Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2167 Page 6 of 31
mifepristone. Id., ¶ 101. However, FDA still required that mifepristone be administered in a clinic setting. Id.
In 2019, FDA approved a different manufacturer’s abbreviated NDA for a generic version of mifepristone and established the Mifepristone REMS Program, which covered both Mifeprex and the generic drug. Id. at 32, ¶ 103; ECF No. 51-3. In May 2020, American College of Obstetricians and Gynecologists (“ACOG”) sued FDA, challenging the Mifepristone REMS Program’s in-person dispensing requirement in light of the COVID-19 pandemic. ECF No. 35, ¶ 104. In that case, the district court temporarily enjoined FDA from enforcing the in-person dispensation requirements under the REMS in light of the COVID-19 pandemic. American College of Obstetricians and Gynecologists v. United States Food and Drug Administration, 47 2F. Supp. 3d 183 (D. Md. 2020).
In April 2021, FDA suspended the in-person dispensing requirement during the COVID-19 public health emergency because, during the six-month period in which the in-person dispensing requirement had been enjoined, the availability of mifepristone by mail showed no increases in serious patient safety concerns. Id., ¶ 105.
On May 7, 2021, FDA announced it would review whether the Mifepristone REMS Program should be modified. ECF No. 51-4. FDA reviewed materials between March 29, 2016 and July 26, 2021, as well as publications found on
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 6
