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.
2/12/2025, 9:01 AMSummary of Bill HR 685
Bill 119 hr 685, also known as the "Abortion Drug Safety Act of 2021," aims to amend the Federal Food, Drug, and Cosmetic Act to impose stricter regulations on abortion drugs. The bill seeks to prohibit the approval of new abortion drugs, as well as investigational use exemptions for these drugs. Additionally, the bill proposes to impose additional regulatory requirements on previously approved abortion drugs.The main goal of this legislation is to enhance the safety and oversight of abortion drugs in the United States. Supporters of the bill argue that these measures are necessary to protect the health and well-being of women who choose to undergo medical abortions.
Critics of the bill, however, argue that it restricts access to safe and effective abortion care and interferes with a woman's right to make decisions about her own body. They also raise concerns about the potential impact of the bill on healthcare providers and patients. Overall, Bill 119 hr 685 is a controversial piece of legislation that has sparked debate among lawmakers, healthcare professionals, and advocacy groups. It remains to be seen how this bill will progress through the legislative process and what its ultimate impact will be on the regulation of abortion drugs in the United States.
Congressional Summary of HR 685
Support And Value Expectant Moms and Babies Act of 2025 or the SAVE Moms and Babies Act of 2025
This bill prohibits the Food and Drug Administration (FDA) from approving any new drug (either as a brand-name drug or a generic) intended to terminate a pregnancy and imposes additional restrictions on such drugs that are already approved.
Under the bill, an already-approved drug intended to terminate a pregnancy may be dispensed to a patient only with a prescription. Furthermore, the FDA may not approve any labeling change that would authorize (1) using the drug after 70 days of gestation, or (2) dispensing the drug by any means other than in-person administration by the prescribing health care practitioner.
The FDA must also impose additional restrictions on such already-approved drugs, including by (1) requiring the prescribing health care practitioner to receive a special certification, (2) prohibiting the practitioner from also acting as the dispensing pharmacist, and (3) requiring the practitioner to have the ability to provide surgical intervention to the patient.
The bill also rescinds any investigational use exemption already granted to such a drug if the bill would have prohibited the FDA from granting the exemption. (Currently, the FDA may grant an exemption to certain market approval requirements if a drug is intended solely for use in safety and effectiveness investigations.)
