FDA Allows Dispensing of Mifepristone in Retail Pharmacies

In the wake of the Dobbs v. Jackson Women’s Health Organization decision, access to mifepristone also known as medication abortion has been important to patients who are seeking to terminate a pregnancy. In a step to address these access issues, the FDA has removed the restriction that prevented retail pharmacies from selling the drug. Retail pharmacies can now sell it following a certification process.¹ Mail-order pharmacies had previously been allowed to dispense the drug.

The process to make this change was started in December 2021 and was not in response to any state laws on abortion. The medication was made following a review by the FDA that examined published research, review of adverse event data. In addition, the change also removes the requirement that it is dispense in-person, which has long been considered a hurdle for its use.

The move was met with approval by women’s health medical organizations. The American College of Obstetricians and Gynecologists (ACOG) released a statement² saying, “Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients. ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order if that is right for them.” ACOG also noted that they would continue to urge the removal of the risk evaluation and mitigation strategy for mifepristone, stating that would be consistent with the clinical evidence.

References

1. Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. Guidance. FDA. Updated January 4, 2023. Accessed January 5, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#:~:text=Under%20the%20Mifepristone%20REMS%20Program%2C%20as%20modified%2C%20Mifeprex%20and%20its,supervision%20of%20a%20certified%20prescriber.
2. ACOG releases statement on FDA announcement regarding changes to restrictions on provision of mifepristone. News Release. ACOG. January 3, 2023. Accessed January 5, 2023. https://www.acog.org/news/news-releases/2023/01/statement-fda-announcement-regarding-changes-to-restrictions-on-provision-of-mifepristone