Protecting Life from Chemical Abortions Act 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 the FDA from (1) exercising any enforcement discretion with respect to program requirements, or (2) reducing program protections until every state submits certain data regarding abortions to the Centers for Disease Control and Prevention. The bill also generally prohibits the declaration of a public health emergency with respect to abortions.
If enacted, this legislation would substantially affect access to abortion services in the U.S., particularly chemical abortions. By reinstating the in-person dispensing requirement, the bill would likely increase barriers for patients seeking medication abortions, as it removes the ability to obtain such medications through mail-order pharmacies. The bill also mandates that any changes to the Rem Risk Evaluation and Mitigation Strategy (REMS) program will only be permissible once significant abortion data is submitted to federal health authorities by each state. This mechanism is designed to restrict the fluidity of current regulations concerning abortion medication.
House Bill 384, also known as the 'Protecting Life from Chemical Abortions Act', seeks to prohibit the Secretary of Health and Human Services from declaring any public health emergency concerning abortion. The bill effectively terminates any existing declarations related to this issue upon its enactment. Furthermore, it aims to nullify certain changes made by the FDA regarding the dispensing requirements of mifepristone, an abortion drug. Specifically, it reinstates the in-person dispensing requirement that was suspended during the COVID-19 pandemic, requiring that mifepristone be dispensed only in medical settings and under the supervision of certified healthcare providers.
Discussions surrounding HB 384 highlight a deep division among lawmakers. Supporters of the bill argue that it is necessary to ensure patient safety by mandating that abortions are conducted in clinical settings with direct oversight from healthcare professionals, thereby reducing potential health risks associated with chemical abortions administered outside such environments. However, opponents contend that the bill undermines women's healthcare rights and access to necessary medical interventions, particularly in regions where clinic access is limited, exacerbating existing inequalities in healthcare access for pregnant individuals.