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 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.472 F. [sic] 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