Bridging the Divide White Paper on Medication Abortion: Overview of Research & Policy in the United States

Abstract

Medication abortion (also called medical abortion) is a safe method of abortion available for the past 15 years in the US. The Bridging the Divide white paper summarizes the scientific evidence related to the current medication abortion process and potential changes to the process that could make it even safer and more accessible for patients, as well as policy considerations and directions for future research. In the fall of 2000, the US Food & Drug Administration (FDA) approved the drug Mifeprex© (generic: mifepristone) for use in medication abortions. That approval included requirements that affect both patients and providers and that are far more specific than typical requirements for prescription drugs. The package insert (also known as the product label) indicated procedures for mifepristone prescribers to follow, based on the regimen used during the drug’s pre-approval clinical trials. FDA has not approved any other abortion drugs besides Mifeprex. Fifteen years later, in March 2016, the FDA approved an updated label for Mifeprex, marking an important step forward for access to abortion care and for evidence-based policy. Although the new label is progress toward policy that is informed and driven by scientific research, the change came many years after research data had demonstrated the safety and efficacy of widely used evidence-based protocols. In the intervening years, some states took advantage of the outdated requirements in the product label and implemented restrictive policy measures that prevented their residents from accessing care based on the latest evidence and best practice. The Bridging the Divide white paper on the current state of medication abortion evidence and policy can be found below, along with a shorter summary document for policy-makers and a recently published commentary from the journal Women’s Health Issues