Mifepristone’s REMS Criteria: Dangerous During COVID-19 and Beyond

At a time when COVID-19 transmission is peaking, millions of women have reduced access to family planning care. On January 12th, 2021, the Supreme Court ruled to reinstate the Risk Evaluation and Mitigation Strategy (REMS) program for mifepristone, which requires patients to go to a hospital, clinic, or medical office to pick up the medication in person and sign a disclosure form. Mifepristone is a drug used in combination with misoprostol to end pregnancies, either for induced medical abortion or miscarriage management. And while there are numerous studies suggesting it is safe for patients to receive all physician consultations for mifepristone via telemedicine and take both prescriptions at home without medical supervision, mifepristone is the only FDA- approved drug with this specific dispensing requirement ¹.

This regulation is medically unnecessary and does not improve the safety of abortion ². Instead, it may increase the risks associated with abortion by posing access barriers to patients, which are further heightened due to the COVID-19 pandemic. Medication abortion is a safe option available to women through the first 10 weeks of pregnancy. However, if difficult to obtain, a woman may end up seeking abortion care later in pregnancy, or not at all. Such was the case for one of our patients. Valerie* was a young patient admitted to our inner-city hospital for suicidal ideation. They reported this was because she could not get an appointment at an outside facility for early abortion care secondary to COVID-19. The first available appointment put her beyond the gestational age for a medical abortion. This all could have been avoided if she had the option to get the medication delivered safely to her home.

The REMS regulation also increases the number of clinic visits and in-clinic contacts required to access abortion, which increases the risk of COVID-19 transmission among patients and healthcare workers ³. A recent study estimated that medically unnecessary abortion regulations, including REMS, resulted in 31,132 additional clinic visits (142,910 in-clinic contacts) each month during the early COVID-19 pandemic ³. Additionally, the implications of reinstating REMS for mifepristone disproportionately affect patients who are low-income, Black and/or Hispanic/Latinx, and those who live in regions without abortion providers, thus potentially further exacerbating existing disparities in healthcare ⁴. Permanently removing REMS is long overdue and imperative to promoting equity in the provision of evidence-based abortion care during the COVID-19 pandemic and after.

*Name changed for anonymity