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 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.
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.
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.)
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.
A bill to direct the Secretary of Health and Human Services to conduct a study to assess the unintended impacts on the health and safety of people engaged in transactional sex, in connection with the enactment of the Allow States and Victims to Fight Online Sex Trafficking Act of 2017 and the loss of interactive computer services that host information related to sexual exchange, to direct the Attorney General to submit a report on human trafficking investigations and prosecutions in connection with the same, and for other purposes.
This bill establishes which state law governs health insurers offering coverage in multiple states. Specifically, the bill provides that the laws of a state designated by a health insurer (primary state) apply to individual health insurance coverage offered by that insurer in any other state (secondary state) if the coverage, states, and insurer comply with the conditions of this bill. Insurers are exempted from any secondary state's laws that would prohibit or regulate the operation of the insurer in that state. The primary state is given sole jurisdiction to enforce its covered laws in any secondary state. The Government Accountability Office must study the effect of this bill on specified health insurance issues.