Support And Value Expectant Moms and Babies Act of 2025 or the SAVE Moms and Babies Act of 2025This 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.)
The changes proposed in HB 685 would have a substantial impact on access to abortion medications. The bill mandates that abortion drugs can only be administered in medical facilities by certified health care practitioners, effectively restricting access to pharmacies and outpatient clinics. This could lead to increased burdens for patients seeking abortion services, as it limits their options for obtaining these medications. Moreover, it emphasizes a reporting mechanism for adverse events, increasing the accountability of health care professionals and manufacturers regarding potential complications associated with abortion drug use.
House Bill 685, known as the 'Support And Value Expectant Moms and Babies Act of 2025,' proposes significant amendments to the Federal Food, Drug, and Cosmetic Act aimed at regulating abortion drugs more strictly. The bill seeks to prohibit the approval of new abortion drugs and disallows investigational use exemptions for these drugs. Additionally, it imposes stringent regulatory requirements on previously approved abortion drugs, intending to ensure that such medications are dispensed only in controlled health care environments.
The bill has sparked considerable debate among lawmakers and healthcare advocates. Proponents assert that the bill's rigorous regulations are necessary to protect the health and safety of women undergoing abortion procedures, citing concerns over complications and the importance of thorough medical oversight. Conversely, opponents argue that these restrictions are a form of overreach that could limit women's healthcare choices and infringe upon their reproductive rights. The contention centers around balancing safety and accessibility, as well as the underlying moral and ethical implications surrounding abortion in general.