23-10362
804–36. And on the very same day in March 2016, FDA approved several major changes to mifepristone’s approved conditions of use, including its REMS. Specifically, FDA removed four of the original safety restrictions by (1) increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion (the “2016 Major REMS Changes”). FDA Add. 777–802.
In March 2019, one of the plaintiff associations filed a second citizen petition challenging the 2016 Major REMS Changes (the “2019 Citizen Petition”). FDA Add. 192–217. That petition asked FDA to “restore” the 2000 Approval’s REMS and “retain” a requirement that mifepristone be dispensed to patients in person. FDA Add. 192.
In April 2019, FDA approved GenBioPro, Inc’s ANDA for a generic version of mifepristone (the “2019 Generic Approval”). PI App. 694–708. GenBioPro’s generic version of mifepristone has the same labeling and REMS requirements as Danco’s Mifeprex.
In April 2021, FDA announced that it would “exercise enforcement discretion” to allow “dispensing mifepristone through the mail … or through a mail-order pharmacy” during the COVID-19 pandemic (the “2021 Mail-Order Decision”). PI App. 713–15. FDA took this action in response to a letter from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. PI App. 710–11.
Later that year, in December 2021, FDA denied almost all of the 2019 Citizen Petition (the “2021 Petition Denial”). FDA Add. 837–76. In particular, FDA expressly rejected the 2019 Citizen Petition’s request to keep the in-person dispensing requirements and announced that the agency
5
