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Update: FDA’s Decision on Mifepristone REMS


The US Food and Drug Administration (FDA) has long regulated mifepristone, also known as the abortion pill, under a Risk Evaluation and Mitigation Strategy (REMS). Despite mifepristone and misoprostol being one safe, effective way to provide abortion and early pregnancy loss (EPL) care, the FDA restrictions have limited where and who can provide this essential health care. On December 16, 2021 the FDA officially completed its comprehensive review of the mifepristone REMS and announced it would permanently lift the in-person dispensing requirement on mifepristone. This allows clinicians and pharmacies to dispense mifepristone in-person or through the mail. However, the FDA also added a new rule to require pharmacies that dispense mifepristone be certified to do so. The manufacturers of mifepristone are in discussions with the FDA on how to implement the new pharmacy-dispensing rules.

While these changes bring us one step closer to improved access, it does not go far enough. More work is needed to make mifepristone truly accessible and available to everyone. While clinics that have been able to provide telehealth abortion care and to mail the pills during the pandemic can continue to do so after this public health emergency, 19 states ban telehealth for abortion. This inhibits people in these states from getting the medications mailed to them even with these changes to the REMS. And, anti-abortion lawmakers in multiple states are moving to ban mailing mifepristone, to pass their own versions of REMS, and to limit medication abortion at earlier than 10 weeks.

It is crucial that we continue to work and fight to dismantle these oppressive state laws that chip away at – and outright deny – reproductive rights. We must repeal the Hyde Amendment, pass the Women’s Health Protection Act, and train and support all primary care clinicians to provide comprehensive reproductive health care.

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