background
Photo by Daniel H. Tong on Unsplash
News /

Gynuity’s Research is Primary Source Cited in the U.S. Food and Drug Administration’s Decision to Suspend In-Person Mifepristone Dispensing Requirement

A published summary of the expansion of the TelAbortion study during the COVID-19 pandemic was the primary source cited in the U.S. Food and Drug Administration’s (FDA) decision to suspend the in-person mifepristone dispensing requirement.

In a letter to the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (accessible via ACOG’s Twitter account), the FDA’s Center for Drug Evaluation and Research noted that the findings from this and three other studies “do not appear to show increases in serious safety concerns (such as hemorrhage, ectopic pregnancy, or surgical interventions) occurring with medical abortion as a result of modifying the in-person dispensing requirement”. The agency intended to “exercise enforcement discretion” with respect to this requirement for the duration of the public health emergency. The determination came into effect on April 12, 2021.

Gynuity’s TelAbortion study – a groundbreaking research project designed to evaluate the use of telemedicine for providing medical abortion in the U.S. – was launched in 2016 at a time when telemedicine abortion was a newly emerging idea with little documentation available for policymakers. Gynuity was granted special dispensation from the FDA to mail the abortion pills to study participants.

Our research has shown that this model of early medical abortion care, which allows abortion-seekers to be counseled remotely and receive the mifepristone and misoprostol medications through the mail, is safe, efficacious and acceptable.

Explanatory Note
The FDA regulates mifepristone by a Risk Evaluation and Mitigation Strategy (REMS) Program and associated Elements to Assure Safe Use (ETASU). These regulations stipulate that mifepristone must be dispensed in certain healthcare settings; providers must register as certified prescribers; and, abortion-seekers must sign an agreement that is separate from standard informed consent.