HR 427 — SAVE Moms and Babies Act of 2023

Summary

To amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval of new abortion drugs, to prohibit investigational use exemptions for abortion drugs, and to impose additional regulatory requirements with respect to previously approved abortion drugs, and for other purposes.

Bill Text

• Introduced Introduced in House Current html January 20, 2023

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill prohibits the approval of new abortion drugs and imposes additional restrictions on previously approved abortion drugs.

• 21 U.S.C. 355

  (aa) Abortion Drugs.--(1) Prohibitions.--The Secretary shall not approve--(A) any application submitted under subsection (b) or (j) for marketing an abortion drug; or(B) grant an investigational use exemption under subsection (i) for--(i) an abortion drug; or(ii) any investigation in which the unborn child of a woman known to be pregnant is knowingly destroyed.

  This change makes it illegal for the Secretary to approve any new applications or investigational use exemptions for abortion drugs.

• 21 U.S.C. 355

  (2) Previously approved abortion drugs.--If an approval described in paragraph (1) is in effect for an abortion drug as of the date of enactment of the Support And Value Expectant Moms and Babies Act of 2023, the Secretary shall--(A) not approve any labeling change--(i) to approve the use of such abortion drug after 70 days gestation; or(ii) to approve the dispensing of such abortion drug by any means other than in-person administration by the prescribing health care practitioner.

  This provision prohibits any changes to labeling that would allow abortion drugs to be used after 70 days of gestation or to be dispensed in ways other than in-person.

• 21 U.S.C. 355

  (B) treat such abortion drug as subject to section 503(b)(1); and

  This stipulation ensures that previously approved abortion drugs are treated under stricter regulations.

• 21 U.S.C. 355

  (C) require such abortion drug to be subject to a risk evaluation and mitigation strategy under section 505-1 that at a minimum--(i) requires health care practitioners who prescribe such abortion drug--(I) to be certified in accordance with the strategy; and(II) to not be acting in their capacity as a pharmacist;

  This enforces additional regulatory requirements for abortion drugs, requiring prescribers to be certified and limiting their role.

• 21 U.S.C. 355

  (iii) limits the dispensing of such abortion drug to patients--(I) in a clinic, medical office, or hospital by means of in-person administration by the prescribing health care practitioner; and(II) not in pharmacies or any setting other than the health care settings described in subclause (I);

  This restricts the places where abortion drugs can be dispensed, ensuring they are administered only in healthcare settings.

• 21 U.S.C. 355

  (iv) requires the prescribing health care practitioner to give to the patient documentation on any risk of serious complications associated with use of such abortion drug and receive acknowledgment of such receipt from the patient;

  This amendment mandates that patients be informed about potential serious risks before receiving abortion drugs.

• 21 U.S.C. 355

  (5) Definitions.--In this section: (A) The term `abortion drug' means any drug, substance, or combination of drugs or substances that is intended for use or that is in fact used (irrespective of how the product is labeled) to intentionally kill the unborn child of a woman known to be pregnant, or to intentionally terminate the pregnancy of a woman known to be pregnant, with an intention other than--(i) to produce a live birth;(ii) to remove a dead unborn child; or(iii) to treat an ectopic pregnancy.

  This definition clarifies what constitutes an 'abortion drug,' impacting regulation and approval.

Action History

1. January 20, 2023

   Introduced in House

2. January 20, 2023

   Introduced in House

3. January 20, 2023

   Referred to the House Committee on Energy and Commerce.

4. January 27, 2023

   Referred to the Subcommittee on Health.

Sponsors

• Robert E. Latta · Primary

Subjects