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.
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.
Plain Language Summary
# HR 679 Summary **What the bill would do:** This bill would reverse FDA changes made in January 2023 that relaxed how the abortion pill mifepristone can be dispensed to patients. Specifically, it would reinstate an in-person dispensing requirement, meaning patients would need to pick up the medication directly from a clinic, medical office, or hospital rather than receiving it by mail from a pharmacy. **Who it affects:** The bill would impact patients seeking medication abortion (which uses mifepristone to end pregnancies up to 10 weeks), healthcare providers who prescribe or dispense the drug, and mail-order pharmacies currently permitted to distribute it. **Key context:** The FDA originally required in-person dispensing for safety monitoring. During COVID-19, this requirement was temporarily suspended, allowing mail delivery.
In 2023, the FDA permanently removed the in-person requirement, making mifepristone more accessible by mail. This bill seeks to reverse that decision and restore the in-person requirement. **Current status:** The bill is currently in committee and has not yet advanced further in the legislative process.
CRS Official Summary
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.
Latest Action
Referred to the House Committee on Energy and Commerce.