Huge: FDA approves abortion pill to be sold at retail pharmacies

via Pam Belluck of the New York Times:

For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication.

Until now, mifepristone — the first pill used in the two-drug medication abortion regimen — could be dispensed only by a few mail-order pharmacies or by specially certified doctors or clinics. Under the new F.D.A. rules, patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by certain other criteria can dispense the pills in its stores and by mail order.

This would be a pretty big deal anyway, but given the Supreme Court's recent repeal of Roe vs. Wade, it obviously takes on even more significance.

via the FDA's website:

Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

Mifeprex (mifepristone) and its generic Mifepristone Tablets, 200 mg (collectively mifepristone) are approved, in a regimen with misoprostol, to end an intrauterine pregnancy through ten weeks gestation (70 days or less since the first day of a patient’s last menstrual period). The FDA first approved Mifeprex in 2000 and approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg in 2019.

Risk Evaluation and Mitigation Strategy (REMS) Information

Mifeprex and its generic Mifepristone Tablets, 200 mg, are available under a single, shared system risk evaluation and mitigation strategy (REMS), known as the Mifepristone REMS Program, which sets forth the requirements that must be followed for mifepristone for medical termination of pregnancy through ten weeks gestation.

Under the Mifepristone REMS Program, mifepristone must be dispensed by or under the supervision of a certified prescriber or by certified pharmacies for prescriptions issued by certified prescribers. Under the Mifepristone REMS Program, mifepristone may be dispensed in-person or by mail.

Mifeprex was approved in 2000 with restrictions to assure its safe use. Mifeprex was deemed to have in effect an approved REMS under the Food and Drug Administration Amendments Act of 2007. In 2019, at the same time the FDA approved the generic version of Mifeprex, the agency approved a single, shared system REMS for mifepristone products for the medical termination of intrauterine pregnancy through 70 days gestation (known as the Mifepristone REMS Program).

In 2021, after conducting a review of the Mifepristone REMS Program, the FDA determined that the available data and information support modification of the REMS to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks. The Mifepristone REMS Program was modified on January 3, 2023. Under the Mifepristone REMS Program:

  • Mifepristone must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program.
  • In order to become certified to prescribe mifepristone, health care providers must complete a Prescriber Agreement Form.
  • The Patient Agreement Form must be reviewed with and signed by the patient and the health care provider, and the risks of the mifepristone treatment regimen must be fully explained to the patient before mifepristone is prescribed.
  • The patient must be provided with a copy of the Patient Agreement Form and mifepristone Medication Guide (FDA-approved information for patients).
  • Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber.
  • To become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form.
  • Certified pharmacies must be able to ship mifepristone using a shipping service that provides tracking information.
  • Certified pharmacies must ensure mifepristone is dispensed to the patient in a timely manner.