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.
If passed, HB 679 would directly impact the legal framework surrounding abortion medications, particularly mifepristone. This would involve the nullification of any modifications to the REMS currently in place that govern how this medication is prescribed and distributed. Critics of the bill argue that it could restrict access to safe and legal abortion care by imposing undue burdens on healthcare providers and patients, straying further from a patient's right to choose. The bill's enactment could lead to a reevaluation of state healthcare laws concerning abortion access and legislation surrounding women's reproductive health.
House Bill 679 seeks to nullify recent modifications made by the Food and Drug Administration (FDA) in January 2023 to the risk evaluation and mitigation strategy (REMS) for the abortion pill mifepristone. The core aim of the bill is to reinstate previous regulations regarding the distribution and use of mifepristone, particularly its availability and safety measures required for its administration. Proponents of the bill assert that recent FDA changes compromise patient safety and could lead to increased risk in the use of the medication, suggesting that stricter controls are necessary to ensure the pill’s proper administration.
The introduction of HB 679 has sparked significant debate among legislators and advocacy groups. Supporters emphasize the need for stricter regulations to protect women’s health, asserting that the recent changes by the FDA were made without adequate consideration of potential health risks. Conversely, opponents raise concerns that the bill represents an attempt to undermine access to abortion services and limit women's autonomy over their reproductive choices, which they argue runs counter to established legal precedents. The bill's potential to restrict access to mifepristone will undoubtedly continue to be at the forefront of contentious discussions surrounding abortion rights in the U.S.