Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 5 of 67 PageID 4427
In March 2019, Plaintiffs AAPLOG and American College of Pediatricians filed the 2019 Petition challenging FDA’s 2016 removal of safety restrictions. Id. On April 11, 2019, FDA approved GenBioPro, Inc.’s abbreviated new drug application (“ANDA”) for a generic version of mifepristone without requiring or reviewing new peer-reviewed science (“2019 Generic Approval”). Id. Two years later, on April 12, 2021, FDA announced it would “exercise enforcement discretion” to allow “dispensing of mifepristone through the mail … or through a mail-order pharmacy” during the COVID pandemic — notwithstanding the nearly 150-year-old Comstock Act banning the mailing of “[e]very article, instrument, substance, drug, medicine or thing” that produces “abortion.” Id. Finally, on December 16, 2021, FDA denied most of Plaintiff’s 2019 Petition. Id. at 11. Specifically, FDA expressly rejected the 2019 Petition’s request to keep the in-person dispensing requirements and announced that the agency would permanently allow chemical abortion by mail. Id.
After Plaintiffs filed suit, Danco Laboratories, LLC (“Danco”) — the holder of the NDA for mifepristone — moved to intervene as a defendant. ECF No. 19. On February 6, 2023, this Court granted Danco’s motion. ECF No. 33. Plaintiffs now seek a preliminary injunction ordering Defendants to withdraw or suspend: (1) FDA’s 2000 Approval and 2019 Approval of mifepristone tablets, 200 mg, thereby removing both from the list of Approved Drugs; (2) FDA’s 2016 Changes and 2019 Generic Approval; and (3) FDA’s April 12, 2021, Letter and December 16, 2021, Response to the 2019 Petition concerning the in-person dispensing requirement for mifepristone. ECF No. 7 at 12. Additionally, Plaintiffs seek to enjoin Defendants from taking actions inconsistent with these orders. Id.
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