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U.S. studies on medication abortion without in-person clinician dispensing of mifepristone

In this brief, ANSIRH reviews research on the provision of medication abortion without in-person dispensing of mifepristone by a clinician in the United States (U.S.). In all six studies reviewed, the effectiveness of the medication abortion was high, and serious adverse events were uncommon.

The FDA’s Risk Evaluation and Mitigation Strategy for Mifepristone

The most effective regimen for medication abortion uses mifepristone, followed by misoprostol. The Food and Drug Administration (FDA) has imposed a Risk Evaluation and Mitigation Strategy (REMS) on mifepristone, which requires it to be dispensed only in a clinic, medical office, or hospital by a certified provider. There is increasing interest in removing the REMS, which creates barriers in accessing medication abortion for patients. The FDA suspended the in-person dispensing requirement during the COVID-19 public health emergency, and then, after reviewing the evidence, permanently removed it in December 2021 and allowed for certified brick-and-mortar and mail-order pharmacists to dispense mifepristone. 

Data Supports Removal of Mifepristone’s In-Person Dispensing Requirement 

Research on the provision of medication abortion without in-person dispensing of mifepristone in the U.S., in combination with data from other countries, indicates that the in-person dispensing requirement of the mifepristone REMS is not necessary to ensure medication abortion effectiveness or safety, and supports its permanent removal.

Download the full issue brief summarizing U.S. studies on medication abortion without in-person clinician dispensing of mifepristone.

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