Protecting Access to Medication Abortion Act of 2023
Impact
The proposed modifications to the REMS could have profound implications for state laws and healthcare practices related to abortion medications. Supporters argue that by facilitating easier access to mifepristone, SB237 addresses barriers that disproportionately affect women and can lead to better health outcomes. This bill could counteract previous legislative efforts in various states aimed at restricting access to abortion, signaling a shift towards protecting reproductive rights and improving healthcare delivery mechanisms. However, the shift in regulation may necessitate adjustments in state-level laws regarding pharmacy practices and telehealth regulations.
Summary
SB237, known as the "Protecting Access to Medication Abortion Act of 2023," aims to enhance patient access to medication abortion, specifically focusing on the drug mifepristone. This legislation proposes significant changes to the current risk evaluation and mitigation strategies (REMS) that govern the dispensing of mifepristone. By eliminating the in-person dispensing requirement, allowing telehealth access for prescriptions, and enabling certified pharmacies to dispense and mail the medication, the bill seeks to improve accessibility, particularly for those in remote areas or with limited mobility.
Contention
Despite its intentions, SB237 is likely to encounter significant opposition from conservative factions and anti-abortion advocates who view the increased accessibility of mifepristone as a threat to unborn life. Critics may argue that facilitating abortion through telehealth and mail-order pharmacies undermines safety protocols and could lead to potential misuse of medication. Additionally, concerns over the adequacy of regulatory oversight in telehealth prescriptions may arise, casting doubt on the safety and efficacy of remotely prescribed medications.
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.
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.