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H.R. 679 · 119th Congress

To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation…

Full title

To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

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This bill nullifies certain changes made by the Food and Drug Administration (FDA) to dispensing requirements for mifepristone. (Mifepristone is a drug that is approved to end pregnancies through 10 weeks gestation when used in conjunction with the drug misoprostol. The procedure is often referred to as medication abortion or the abortion pill.)

What it does: CRS summary · Introduced in House · Jan 23, 2025

This bill nullifies certain changes made by the Food and Drug Administration (FDA) to dispensing requirements for mifepristone. (Mifepristone is a drug that is approved to end pregnancies through 10 weeks gestation when used in conjunction with the drug misoprostol. The procedure is often referred to as medication abortion or the abortion pill.)

The FDA regulates the use of mifepristone through the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program. The program requires health care providers to comply with certain requirements in order to prescribe or dispense mifepristone to end a pregnancy; the program previously included an in-person dispensing requirement that required mifepristone to be directly dispensed to patients in clinics, medical offices, or hospitals. During the COVID-19 public health emergency, the FDA temporarily stopped enforcing the in-person dispensing requirement, which allowed mail-order pharmacies to fill and dispense mifepristone prescriptions.

In January 2023, the FDA modified program requirements so as to (1) remove the in-person dispensing requirement, and (2) require pharmacies to be certified in the program in order to dispense mifepristone. The modifications allow retail pharmacies, after receiving certification, to dispense mifepristone pursuant to prescriptions that are written by program-certified prescribers.

The bill nullifies the January 2023 changes and prohibits any similar changes in the future.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

Latest action (Jan 23, 2025): Referred to the House Committee on Energy and Commerce.

Policy area: Health · Origin: House · Introduced: Jan 23, 2025

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.