To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

Bill: 118-hr-383
Sponsor: full_name: Rep. Harshbarger, Diana [R-TN-1]
Introduced: 2023-01-17
Policy area: Health
Latest action: action_date: 2023-01-27
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-01-17
action_desc: Introduced in House
text: <p>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.)</p> <p>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. </p> <p>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.</p> <p>The bill nullifies the January 2023 changes and prohibits any similar changes in the future.</p>

tv_txt: I 118th CONGRESS 1st Session H. R. 383 IN THE HOUSE OF REPRESENTATIVES January 17, 2023 Mrs. Harshbarger (for herself, Mr. Hern , Mr. Lamborn , Mr. Baird , Mr. Carter of Georgia , Mr. Weber of Texas , Mrs. Miller of Illinois , Mr. Banks , Mr. Jackson of Texas , Mr. Webster of Florida , Mr. Duncan , Mr. Feenstra , Mr. Smith of New Jersey , and Mr. Gosar ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

1. Nullification of modifications to REMS for mifepristone (a) Nullification The modifications made by the Food and Drug Administration in January 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 are hereby nullified. (b) No substantially similar provisions The Secretary of Health and Human Services (or any head of any office, department, or agency of the Department of Health and Human Services) shall not establish, implement, or enforce any provision of a 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 that is substantially similar to any of the modifications nullified by subsection (a).