Support And Value Expectant Moms and Babies Act of 2023 or the SAVE Moms and Babies Act of 2023 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.)
The implications of HB 427 are significant as it not only attempts to halt the introduction of new abortion medications but also places undue regulatory burdens on practitioners who prescribe existing approved drugs. The bill mandates practitioners to undergo special certification to prescribe these drugs and prohibits them from dispensing the drugs through pharmacies, effectively controlling how these medications can be accessed. This consolidation of regulatory authority could lead to decreased availability of abortion services, particularly for those in remote or underserved areas, thus raising concerns about access to necessary healthcare.
House Bill 427, known as the Support and Value Expectant Moms and Babies Act of 2023 (SAVE Moms and Babies Act), seeks to amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval of new abortion drugs and impose further restrictions on existing ones. This bill categorically bans the FDA from granting marketing approvals for any new drugs intended for abortion, thereby significantly restricting the available options for medically-assisted terminations. Additionally, it stipulates that existing drugs must only be dispensed through in-person administration by certified healthcare practitioners, limiting access for patients in need of such services.
Debate surrounding HB 427 highlights notable divisions among legislators and advocacy groups. Proponents argue the bill protects unborn life and ensures that mothers are provided with adequate medical oversight during termination procedures. In contrast, opponents, including numerous healthcare professionals and reproductive rights advocates, argue that the bill undermines women's health rights and restricts access to safe and effective medical services. They view the bill as part of a broader strategy to limit reproductive choices, potentially leading to increased instances of unsafe abortions.