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.
The enactment of HB 383 would reinstate stricter requirements for the dispensing of mifepristone, potentially impacting access to medication abortion. By prohibiting mail-order pharmacies from dispensing mifepristone, the bill aims to centralize control over the distribution of this medication to certified healthcare providers only. This move may be seen as a measure to enhance the safety of prescribing practices but could also limit access for individuals seeking abortion care, particularly in areas with fewer medical facilities.
House Bill 383 aims to nullify modifications made by the Food and Drug Administration (FDA) in January 2023 regarding the Risk Evaluation and Mitigation Strategy (REMS) for the abortion pill mifepristone. The modifications had allowed for the dispensing of mifepristone via mail order, rather than requiring in-person dispensing at clinics or medical offices. This bill seeks to reverse these changes and establish a regulatory framework that maintains previous restrictions, advocating for in-person dispensing to ensure oversight and safety in the distribution of the medication.
This bill highlights significant divisions in public health policy, particularly concerning reproductive rights. Proponents argue that maintaining stringent dispensing requirements ensures safety and compliance with established medical guidelines, while opponents view it as an unnecessary restriction on access to reproductive healthcare. The contentious nature of this bill reflects broader national debates over abortion access, state regulatory power, and the evolving role of healthcare providers in reproductive health services.