FDA Approves Modifications to Mifepristone REMS Program

FOR IMMEDIATE RELEASE: January 2, 2023
CONTACT: naf@berlinrosen.com

On Tuesday January 3, 2023, the FDA finalized a new version of the REMS on medication abortion care. The agency announced it would permanently lift the in-person dispensing requirement and establish a new program to certify both brick-and-mortar and mail-order pharmacies to dispense mifepristone.

Statement from Melissa Fowler, Chief Program Officer at the National Abortion Federation:

We applaud the FDA for following the science and removing one of the unnecessary, outdated barriers to medication abortion and allowing more people to get the care they need in the way that works best for them. We have known for years, and had the scientific evidence to support, that abortion pills are safe and effective. In a post-Roe U.S. and as anti-abortion politicians continue to restrict access to this essential health care in states across the country, this is an important and necessary step by the FDA to improve access to abortion care for more people. However, while this change potentially allows for more access points in states where abortion is still legal, we do not yet know how many pharmacies will participate in the program or how much it will truly expand access. Every patient deserves to obtain abortion care in the time and place that’s right for them. Today, too many people live in states where they have lost access to essential abortion care, and we have much work to do to so that people have the same access to health care no matter where they live.