Legal Challenges to the FDA Approval of Medication Abortion Pills


Appendix Table 1: Timeline of Regulatory Actions Regarding Mifepristone*
Date Action
March 1996 The Population Council submitted a New Drug Application (NDA) for Mifeprex (Mifepristone).
September 2000 FDA approved Mifeprex for the medical termination of pregnancy through 49 days’ gestation. The approval was granted under FDA’s regulations at 21 C.F.R. Part 314 Subpart H (Subpart H), which permitted FDA to impose conditions the agency deemed necessary to ensure the product’s safe use, including in this instance requirements regarding the capabilities and commitments of each healthcare provider who would be authorized to prescribe the drug and restrictions on how the drug would be distributed.
August 2002 American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and Christian Medical& Dental Associations and Concerned Women for America submitted a citizen petition requesting FDA revoke approval of Mifeprex.
September 2007 Congress amended the Food, Drug, and Cosmetic Act to give FDA authority to require an applicant to submit a risk evaluation and mitigation strategy (REMS) if the agency determined that a REMS “is necessary to ensure that the benefits of the drug outweigh the risks of the drug.” 21 U.S.C. § 355-1(a)(1).
August 2008 The GAO issued a report on the approval and oversight of Mifeprex following a request from several members of Congress.
June 2011 FDA approved the Mifeprex REMS after Danco submitted an application on September 17,2008. The approved REMS maintained and augmented the Subpart H requirements imposed with the initial approval of Mifeprex.
March 2016 FDA denied the 2002 citizen petition requesting to revoke approval of Mifeprex.
March 2016 FDA updated and approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy.
March 2018 The GAO issued a report on FDA’s actions in approving the 2016 changes following a request from several members of Congress.
March 2019 Plaintiffs AAPLOG and ACOP submitted a citizen petition to FDA asking the agency to “restore and strengthen elements of the Mifeprex regimen and prescriber requirements approved in 2000,” and “retain the Mifeprex [REMS], and continue limiting the dispensing of Mifeprex to patients in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.”
April 2019 FDA approved of GenBioPro’s abbreviated new drug application for a generic version of mifepristone. FDA determined that the generic drug was material the “same” as Mifeprex. With this approval, the FDA also approved a Mifepristone REMS program, covering both Mifeprex and the generic medication.
April 2020 The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) sent a letter urging FDA to suspend enforcement of the in-person dispensing requirements of the Mifeprex REMS.
April 2021 FDA responded to the letter from ACOG and SMFM, stating that during the COVID-19 public health emergency, the agency would exercise enforcement discretion with regard to “dispensing of Mifeprex . . . through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.”
May 2021 FDA updated the Mifepristone REMS, adding gender-neutral language to the patient agreement form.
December 2021 FDA responded to the 2019 citizen petition from plaintiffs AAPLOG and ACOP, addressing in detail their concerns, assertions, and the sources cited in support, but denying their request to restore the requirements approved in 2000 and to limit dispensing (for both Mifepristone and Misoprostol) in person.
January 2023 FDA modified the Mifepristone REMS, removing the in-person dispensing requirement.
NOTES: *For the purpose of terminating pregnancy. The FDA has additionally approved a Mifepristone medication to treat Cushing’s disease.
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