Essential Access Health Statement Regarding FDA Rule Change on Mifepristone REMS

Statement by Amy Moy, Co-CEO + Chief External Affairs Officer

Today, the US Food and Drug Administration (FDA) finalized new changes to the Risk Evaluation and Mitigation Strategy program for medication abortion care.

“In a post-Roe world, increasing the availability of medication abortion is a public health imperative to build abortion care capacity and infrastructure in safe haven states.

“The FDA’s long-awaited announcement is a step in the right direction, and has the potential to significantly expand access to safe and effective medication abortion care in states where abortion remains legal. We applaud the FDA for permanently lifting the onerous in-person dispensing requirement, supporting access through telehealth and allowing prescriptions for mifepristone to be dispensed through local pharmacies, creating new access points for essential and time-sensitive health care. 

“Medication abortion has been FDA-approved for over twenty years and now accounts for more than half of abortions in the U.S. Utilization is expected to increase as more states enact harmful abortion bans and severe restrictions. Even prior to the Dobbs decision, there were unnecessary and harmful barriers to access for adolescents, individuals with low-incomes, Black, Indigenous, and People of Color, and in rural regions across the country.

“While the FDA’s action was urgently needed, it also underscores the devastating inequities that have created a “divided states of America” when it comes to health access. The ability to get health care should not be dependent on a patient’s zip code, age, income, race, or the political ideology of their state government.

“We call on the Biden Administration to continue to take meaningful action to ensure that everyone in the US can make the most personal decisions about if and when to have a child and get the care they want and need without delay - with dignity and respect.”