Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB95

Introduced
1/26/23  

Caption

SAVE Moms and Babies Act of 2023 Support And Value Expectant Moms and Babies Act of 2023

Impact

If enacted, SB95 would enforce that no new applications for abortion drugs can be approved, effectively halting any future developments in this area. Additionally, previously approved abortion drugs would face numerous new regulations including in-person administration by certified health care practitioners only, required risk evaluations and mitigation strategies, and mandatory reporting of any adverse events associated with their use. This could lead to reduced availability and increased difficulties for expectant mothers seeking abortions through medical means, significantly impacting state laws regarding reproductive health.

Summary

SB95, known as the 'Support And Value Expectant Moms and Babies Act of 2023' or the 'SAVE Moms and Babies Act of 2023', seeks to amend the Federal Food, Drug, and Cosmetic Act significantly. The primary objective of the bill is to prohibit the approval of new abortion drugs and investigational use exemptions for existing abortion drugs. Furthermore, it imposes stricter regulations on previously approved abortion drugs, creating an entirely new framework for how abortion-related medications are managed within the healthcare system.

Contention

Moreover, the bill's requirement that healthcare practitioners have specific qualifications and the ability to perform surgical interventions raises questions about the practicality of implementation and the potential burden it places on medical facilities. This aspect could lead to disparities in access to reproductive health services, particularly in rural or underserved areas.

Companion Bills

US HB427

Same As 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.)

Similar Bills

No similar bills found.