ACOG Statement on Court’s Order Lifting Burdensome FDA Restriction

Washington, DC – The following is a statement from Eva Chalas, MD, FACOG, FACS, president of the American College of Obstetricians and Gynecologists, on today’s decision from the United States District Court for the District of Maryland:

“Today’s ruling represents a victory for patients, who should not have to face the additional burden of increased COVID-19 exposure as a condition of receiving their prescribed mifepristone. It also represents a victory for the dedicated clinicians who are working to provide needed care without unnecessary exposure of patients, their families and the members of the healthcare team, to the novel coronavirus.

“ACOG undertook this legal challenge because we believe strongly in our position, which is founded on clear science and the consensus of the medical community. Mifepristone is a safe medication and FDA's in-person dispensing requirements provide no medical benefit to patients. There is no basis for FDA’s decision to treat mifepristone differently than other medications. During the COVID-19 pandemic – which is likely to impact the U.S. for many months to come – requiring in-person dispensing of mifepristone needlessly threatens both patients and clinicians, and we are relieved to see that our members and their patients will no longer face this additional burden when it comes to abortion care.

“Nonetheless, we are disappointed that the injunction issued by the Court does not apply to women experiencing miscarriage and the clinicians treating them, putting these individuals at risk for needless COVID-19 exposure and increased potential harm during what is already a painful time for these patients. This decision particularly adversely affects women in states with rising rates of COVID-19 infection with resulting limitation of access to surgical procedures, which may be required to complete the miscarriage in the absence of access to mifepristone. As always, ACOG feels strongly that access to women’s health care should not be singled out and burdened with regulation that renders patient care less accessible or, in this case, potentially dangerous, and we will continue our advocacy to seek removal of these restrictions during the pandemic.

“The FDA’s burdensome in-person dispensing requirement for mifepristone has had a disproportionate effect on communities hit hardest by the pandemic, including communities of color who already face existing inequities and structural barriers to care. Suspending the REMS requirement for mifepristone for early pregnancy termination represents a necessary step forward in our collective work toward health equity during this unprecedented time of pandemic.”