Us Congress 2023-2024 Regular Session

Us Congress House Bill HB5850

Introduced
9/29/23  
Refer
9/29/23  

Caption

To nullify modifications made by the Food and Drug Administration on January 3, 2023, to the risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for mifepristone, and for other purposes.

Impact

If enacted, HB5850 would significantly alter the current regulatory landscape for mifepristone at the federal level. By prohibiting the use of federal funds to establish or implement any provisions similar to those nullified, the bill would effectively limit the FDA's capacity to enforce any modified REMS for mifepristone. This measure could create a new precedent in how medications that relate to reproductive health are managed and regulated, creating more rigid standards for access as well as potential implications for healthcare providers who prescribe these medications.

Summary

House Bill 5850 aims to nullify recent modifications made by the Food and Drug Administration (FDA) regarding the risk evaluation and mitigation strategy (REMS) for mifepristone, a medication commonly used for medical abortions. The bill specifically addresses the changes the FDA implemented on January 3, 2023, which impacted how mifepristone is regulated. By nullifying these modifications, the bill seeks to revert back to previous regulatory standards under the Federal Food, Drug, and Cosmetic Act. This legislative action reflects ongoing debates about access to abortion medication and regulatory oversight in healthcare.

Contention

The bill is likely to be contentious, with significant support and opposition. Supporters argue that nullifying the modifications will help preserve access to mifepristone and ensure that women retain autonomy over their reproductive health choices. Conversely, opponents may view this bill as a step backward in terms of public health and safety, expressing concerns that removing regulatory modifications could pose risks to patients if the medication is not adequately assessed for safety and efficacy. As this issue intertwines with broader national discussions on reproductive rights, the repercussions of this bill may extend beyond regulatory frameworks into the realm of political discourse.

Companion Bills

No companion bills found.

Previously Filed As

US HB679

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.

US HB383

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.

US HB384

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.

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Similar Bills

No similar bills found.