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 that it will permanently eliminate 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We applaud the FDA for following the science and removing one of these unnecessary, outdated barriers to abortion medication and allowing more people to get the care they need in the way that works best for them. We have known for years, and have scientific evidence to back it up, that abortion pills are safe and effective. In a post-Roe The US and while anti-abortion politicians continue to restrict access to this important 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 don’t yet know how many pharmacies will participate in the program or how much it will actually expand. of access. Every patient deserves to get abortion care at a time and place that is right for them. Today, too many people live in states where they have lost access to essential abortion care, and we have more to do so that people have the same access to health care wherever they live.