Mifepristone in the Courts

A case pending at the Federal District Court in Amarillo, Texas, could have catastrophic consequences on the ability of patients across the United States to access needed medication abortion care and miscarriage management. A decision in favor of the plaintiffs in this case would essentially remove mifepristone from the marketplace, affecting every single state (not just those in which abortion is currently illegal) and exacerbating the current abortion care crisis in the U.S.

Used in combination with misoprostol, mifepristone is an important component of the recommended regimen for medication abortion and for the management of early pregnancy loss. In this case, plaintiffs are suing to overturn the 2000 FDA approval of mifepristone for medication abortion, disregarding the decades of data that support the safe and effective use of mifepristone. In fact, it is because of mifepristone’s robust clinical data that ACOG has long advocated for the FDA to overturn burdensome and clinically unnecessary risk evaluation and mitigation strategy for mifepristone in order to increase access to this critical medicine.

According to some legal analysts, the judge in this case could invalidate the FDA’s approval of mifepristone for use in medication abortion, and this decision could take immediate effect. If so inclined, the judge has the power to issue an injunction that applies across the country. If this happens, doctors will not be able to prescribe mifepristone for medication abortion, and the manufacturer of mifepristone will no longer be legally allowed to market mifepristone as part of a two-drug medication abortion regimen.

ACOG, along with several coalition partners, will be providing the court with an amicus brief that will lay out the overwhelming evidence that backs up the safety and efficacy of mifepristone. We will closely monitor the court’s decision and, if the need arises, will provide members with clinical information about how to approach shared decision making with patients in need of abortion care and miscarriage management.