FDA Allows Abortion Medication to be Dispensed at Pharmacies

Following a decision from the U.S. Food and Drug Administration (FDA) released on January 3, 2023, pharmacies will be allowed to offer mifepristone—a drug used for medication abortions—for the first time.  Previous rules required that the drug be given in person at a clinic or hospital. While a person will still need a prescription for mifepristone from a certified healthcare provider, the change expands access by allowing pharmacy pickup or mail delivery.

Mifepristone was first approved by the FDA in 2000 and has been used since then for early nonsurgical abortion. The drug is used is combination with another medication—misoprostol—that is used for other conditions and is already available over the counter.

When first approved, the FDA established what is called a “risk evaluation and mitigation strategy” (REMS) for mifepristone that restricted its use, inclduing the requirement for the drug to be given in person at a certified health center. However, in 2021, the restrictions of the mifepristone REMS Program were relaxed to allow easier access to the medication through mail order pharmacies during the COVID-19 pandemic. That experience ultimately led to the recent updates.

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.

The FDA will require pharmacies that would like to offer the medication to undergo a certification process, but stated that any pharmacy that meets the requirements of the drug safety program is eligible for certification.  According to news reports, at least two large pharmacy chains—Walgreens and CVS—plan to become certified.

The change, while welcome, doesn’t mean anyone will be able to access mifepristone at their local pharmacy, given various state laws restricting access. For example, according to the Guttmacher Institute, 18 states require the clinician providing a medication abortion to be physically present when the medication is administered, prohibiting the use of telemedicine to prescribe medication for abortion.

So while state-based restrictions mean not all persons seeking abortion will benefit from the recent FDA change, the move is a step forward in approving access to safe abortion.