FDA approves mifepristone to be dispensed in certified pharmacies

Mifepristone (Mifeprex), in a regimen with misoprostol, have been approved by the US Food and Drug Administration (FDA) to be dispensed to pharmacies for consumer use.

Mifepristone, also known as RU-486, is a medication used to terminate a pregnancy. The combination is 97% effective during the first 63 days of pregnancy. Misoprostol is a synthetic prostaglandin medication used to prevent and treat stomach and duodenal ulcers, induce labor, and cause an abortion.

Both Mifeprex and the generic mifepristone tablets (200 mg), are available under the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program, which produces the requirements that must be adhered to for medical termination of a pregnancy through 10 weeks. Under this program, mifepristone may be dispensed in person or by mail.

The FDA originally approved Mifeprex in 2000 and in 2019 approved the generic version, at which time the agency also approved a single shared REMS system for all mifepristone products. Until recently, the drug could only be dispensed by a few mail-order pharmacies or certified doctors and clinics. Under the current program:

--Mifepristone must be prescribed by a health care provider and is certified in the Mifepristone REMS Program.

--A patient agreement form must be reviewed with and signed by the patient and the health care provider with the risks of the mifepristone treatment being fully explained to the patient.

--The patient must be provided with a copy of the Patient Agreement Form and mifepristone Medication Guide.

--Mifepristone can only be dispensed under the supervision of a certified prescriber or by a certified pharmacy.

The FDA did not issue an announcement but instead updated its website to reflect the decision, as well as adding a series of questions and answers. The 2 manufacturers of the pill, Danco Laboratories and GenBioPro released statements saying the agency had informed them of their action.

Reference

Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation. US Food and Drug Administration. January 3, 2023. Accessed January 5, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation