How HR 685 changes current law

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 regulatory requirements 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 addition prohibits the FDA from approving any applications for abortion drugs or granting investigational use exemptions for them.

• 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 2025, 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 requires the Secretary to impose restrictions on labeling changes for abortion drugs concerning gestation limits and administration methods.

• 21 U.S.C. 355

  (3) Reporting on adverse events by other health care practitioners.--The Secretary shall require all other health care practitioners to report to the Food and Drug Administration any adverse events experienced by their patients that are connected to use of an abortion drug, excluding any individually identifiable patient information.

  This mandates additional reporting requirements for health care practitioners regarding adverse events linked to abortion drug usage.

• 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 provides a specific definition of 'abortion drug', clarifying what substances fall under the prohibition and regulatory requirements.