Expanded Food Safety Investigation Act of 2023
Expanded Food Safety Investigation Act of 2023
To direct the Secretary of Labor to ensure that the database relating to investigations under the Fair Labor Standards Act of 1938 is language accessible, and for other purposes.
To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring the manufacturers of a covered device to disclose to a patient all patient-specific data that is recorded or transmitted by the device and accessible to the manufacturer, and for other purposes.
To amend the Endangered Species Act of 1973 to provide that artificially propagated animals shall be treated the same under that Act as naturally propagated animals, and for other purposes.
Mandating Exclusive Review of Individual Treatments (MERIT) Act This bill specifies that coverage determinations for drugs and biologics under Medicare must be made with respect to each drug or biologic, rather than with respect to a class of drugs or biologics.
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.)
To provide for a study on food animal microbiomes, and for other purposes.
A bill to provide for the establishment, within the Food and Drug Administration, of an Abraham Accords Office to promote and facilitate cooperation between the Food and Drug Administration and entities in Abraham Accords countries wishing to work with the agency in order to develop and sell products in the United States, and for other purposes.
Wildfire Recovery Act This bill makes changes with respect to the federal cost share for Fire Management Assistance Grants and provides that the federal share shall be not less than 75% of the eligible cost. Specifically, the bill directs the Federal Emergency Management Agency (FEMA) to conduct and complete a rulemaking to provide criteria for the circumstances under which FEMA may recommend that the President increase the federal cost share. Such criteria shall include a threshold metric that assesses the financial impact to a state or local government from responding to a fire for which fire management assistance is being provided.