The US Food & Drug Administration (FDA) announced Thursday that it permanently lifted restrictions on access Mifeprex (mifepristone) and its generic versions, which are used with another medication to end an early pregnancy.
The FDA confirmed that it conducted a review of its mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, conducting a benefits and risks analysis. Through its review, the “FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.” Subsequently, the FDA modified its REMS Program by eliminating an in-person dispensing requirement. Pursuant to the eliminated requirement, providers could only dispense mifepristone in clinics, medical offices, and hospitals. Now, providers can dispense the abortion pill by mail.
The FDA first approved the abortion pill in 2000, adding regulations over time to further restrict access. Under FDA regulations, healthcare providers must provide patients with information on the pill. Providers must also be certified and meet certain qualifications. Furthermore, providers must obtain a signed agreement form before prescribing the pill and afterwards, to ensure that the patient received counseling. Though the FDA’s December announcement eliminated the in-person restriction, it added a requirement that pharmacies dispensing mifepristone be certified.
Earlier this year, the US Supreme Court reinstated the in-person requirement, granting an application for a stay on a district court preliminary injunction. Chief Justice John Roberts concurred, stating that the district court lacked a sufficient basis to compel the FDA to change its medical abortion regime. Justices Sonia Sotomayor and Elena Kagan dissented, writing that the in-person requirement “imposes an unnecessary, unjustifiable, irrational, and undue burden on women seeking an abortion during the current pandemic.”
The preliminary injunction was granted by the US District Court for the District of Maryland due to COVID-19. The injunction temporarily prevented the FDA from requiring patients to physically travel to their health care providers to access mifepristone.
The revised regulation permits “dispensing of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals as currently outlined in the Mifepristone Rems Program.” The FDA notes that applicants began ordering the pill by mail when the restriction was temporarily lifted during COVID-19. According to the FDA announcement, the temporary public health emergency model will remain in effect permanently.
