# Plain Language Summary: SAVE Moms and Babies Act of 2021

This bill would prevent the FDA from approving any new abortion medications and would place strict restrictions on abortion pills that are already approved and in use. Currently, mifepristone (commonly known as RU-486 or the "abortion pill") is the only FDA-approved medication for ending pregnancy. Under this bill, the FDA would be banned from approving any new abortion drugs in the future, and no new uses or methods of distributing existing abortion drugs could be approved.

For medications already on the market, the bill would impose significant new requirements. It would limit their use to the first 70 days of pregnancy (down from the current 77 days allowed by FDA regulations) and would require that these drugs only be given in person at a doctor's office, clinic, or hospital—not through mail or pharmacy pickup. The bill would also require doctors who prescribe these medications to be specially certified and to have specific medical capabilities, including the ability to diagnose ectopic pregnancies, handle incomplete abortions, and provide blood transfusions if needed. Doctors would also be required to report any serious complications to the FDA, including deaths, hospitalizations, infections, and excessive bleeding.

Additionally, the bill would require doctors and other healthcare providers to report all adverse events associated with abortion drugs to the FDA, and it would mandate that the use of these drugs be reported to state authorities in the same way surgical abortions are reported. The bill essentially treats abortion medications like controlled substances requiring close medical supervision and extensive documentation. For women seeking medication abortion, this would mean fewer options, more restrictions on how and when they can access these drugs, and more extensive medical oversight of the process.

SAVE Moms and Babies Act of 2021

Latta, Robert E.

Support And Value Expectant Moms and Babies Act of 2021 or the SAVE Moms and Babies Act of 2021 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 to also act 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.)