The disproportionate burdens of the mifepristone REMS

Of the people who need abortion care in the United States every year, 75% are poor or living on low-incomes and approximately 60% are Black, Indigenous, and other people of color. Black, Indigenous, and other people of color face profound inequities in accessing essential health care as a result of a long history of systemic racism and discrimination. Accessing abortion is no different. Further, due to the stark racial disparities in maternal mortality and morbidity in the United States, Black and Indigenous people who cannot access the abortion care they need confront unconscionably elevated risks in carrying a pregnancy to term. Over the past year, the COVID-19 pandemic has only laid bare and deepened existing health care inequities. Unfortunately, legal barriers to abortion access at the state and federal levels exacerbate these inequities. Among these barriers are the U.S. Food and Drug Administration's (“FDA”) Risk Evaluation and Mitigation Strategy (“REMS”) restrictions for mifepristone—1 of 2 drugs used to end early pregnancy and manage a miscarriage. This Spring, the FDA announced its intention to exercise enforcement discretion for the in-person dispensing requirement of the REMS during the public health emergency. This change, although welcome, is temporary and applies only to one of the REMS restrictions. In May, the FDA stated its intention to conduct a long-awaited review of the REMS as a whole. As long as the REMS remain in place, it will unnecessarily burden access to safe medication for abortion and miscarriage care. Permanently removing the REMS in its entirety is therefore critical to reducing the disproportionate harms of abortion restrictions on communities of color and advancing equity in and access to timely and essential reproductive health care.