Federal

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.

Source: Congress.gov · 351 words in original text

What This Bill Does

This bill cancels changes the Food and Drug Administration made in January 2023 to the risk evaluation and mitigation strategy (a safety plan required by law) for the drug mifepristone. The bill also prevents the Secretary of Health and Human Services from creating similar safety plans for mifepristone in the future.

Who It Affects

The Food and Drug Administration, the Department of Health and Human Services, and the Secretary of Health and Human Services.

Key Provisions

• The modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for mifepristone are canceled (Sec. 1(a)) • The Secretary of Health and Human Services cannot create, put in place or enforce any risk evaluation and mitigation strategy for mifepristone that is substantially similar to the changes that were canceled (Sec. 1(b))

What Changes

If this bill becomes law, the January 2023 changes to the mifepristone safety plan would no longer be in effect. The federal government could not then adopt nearly identical safety plans for this drug.

Important Definitions

None defined in bill text.

I 118TH CONGRESS 1ST SESSION H. R. 383 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. 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. NULLIFICATION OF MODIFICATIONS TO REMS 3 FOR MIFEPRISTONE. 4 (a) NULLIFICATION.—The modifications made by the 5 Food and Drug Administration in January 2023 to the 6 VerDate Sep 11 2014 03:40 Jan 28, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H383.IH H383 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 383 IH risk evaluation and mitigation strategy under section 505– 1 1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2 355–1) for mifepristone are hereby nullified. 3 (b) NO SUBSTANTIALLY SIMILAR PROVISIONS.—The 4 Secretary of Health and Human Services (or any head of 5 any office, department, or agency of the Department of 6 Health and Human Services) shall not establish, imple- 7 ment, or enforce any provision of a risk evaluation and 8 mitigation strategy under section 505–1 of the Federal 9 Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for 10 mifepristone that is substantially similar to any of the 11 modifications nullified by subsection (a). 12 Æ VerDate Sep 11 2014 03:40 Jan 28, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H383.IH H383 kjohnson on DSK79L0C42PROD with BILLS

Important: This plain English summary was generated by AI and is provided for informational purposes only. It is not legal advice. Always consult the official bill text on Congress.gov or a qualified attorney for legal matters.