The FDA’s REMS Restriction limits access to Self-Managed Abortions (SMAs)

Source: NPR

Did you know that the FDA has a restriction called the Risk Evaluation and Mitigation Strategy (“REMS”) for mifepristone — 1 of the 2 drugs used for self-managed abortions (SMAs) or medication abortions in early pregnancy?

The FDA previously announced its intention to exercise enforcement discretion for the in-person dispensing requirement of the REMS during the public health emergency, which is temporary and applies only to one of the REMS restrictions.

The REMS restrictions include “the following 3 principal components: 1) it restricts distribution to clinics, medical offices, and hospitals; 2) it limits prescribing to certified prescribers attesting to their ability to diagnose gestational age and ectopic pregnancies, provide in-person counseling on safe use of the drug, and ensure access to surgical and medical care if needed; and 3) it requires that patients receive a special medication guide and sign an agreement acknowledging drug risks and receipt of counseling.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7592805/

In May, the FDA stated its intention to conduct a long-awaited review of the REMS as a whole. If this restriction is lifted, we will be able to make self managed abortions safer and more accessible.