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.

Subjects: Health

Summary:  <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>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 383 Introduced in House (IH)]

&lt;DOC&gt;






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 Representatives of the 
United States of America in Congress assembled,

SECTION 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).
                                 &lt;all&gt;
</pre></body></html>