Advancing Safe Medications for Moms and Babies Act of 2026

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 8651 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 8651 To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES May 4, 2026 Ms. Castor of Florida (for herself, Mr. Fitzpatrick, and Ms. Underwood) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, 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. SHORT TITLE. This Act may be cited as the ``Advancing Safe Medications for Moms and Babies Act of 2026''. SEC. 2. UPDATING FDA REGULATIONS TO INCLUDE PREGNANT WOMEN IN CLINICAL TRIALS. (a) Purposes.--The purposes of this section are-- (1) to facilitate compliance with applicable Federal regulations relating to the protection of pregnant women participating in research as subjects; and (2) to promote the inclusion of pregnant women in clinical research. (b) Harmonization.--For the purposes specified in subsection (a), the Secretary of Health and Human Services (referred to in this Act as the ``Secretary''), acting through the Commissioner of Food and Drugs, shall, to the extent practicable and consistent with other applicable Federal statutory law, issue such regulations as may be appropriate to harmonize the regulations of the Food and Drug Administration relating to the protection of human subjects, including parts 50 and 56 of title 21, Code of Federal Regulations, with the regulations of the Department of Health and Human Services relating to the inclusion of