FDA Restrictions on Mifepristone: Time for a Change?

Issue Brief

FDA Restrictions on Mifepristone: Time for a Change?

Recent Studies Confirm Clinical and Cost Effectiveness for Medical Management of Early Miscarriage

Mifepristone, a drug used to manage early miscarriage or end an early pregnancy, carries unique restrictions imposed by the U.S. Food and Drug Administration (FDA). Patients are required to pick up the drug in person from a doctor or a clinic, even though they can take the drug at home. In July, a federal court ruled that the FDA must suspend these restrictions during the COVID-19 pandemic, for patients seeking an early abortion, although the ruling did not apply to women with an early pregnancy loss. But the challenges to FDA restrictions on mifepristone predate the pandemic. This Issue Brief provides the context for this ongoing controversy, and reviews recent evidence on the clinical and cost effectiveness of mifepristone for the medical management of first trimester miscarriage.