Prompt Approval of Safe Generic Drugs ActThis bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.
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.)
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.
Prescription Drug Affordability Board Exempt Orphan Drugs
Support And Value Expectant Moms and Babies Act of 2025 or the SAVE Moms and Babies Act of 2025This 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.)
Lower Drug Costs for Families Act This bill applies certain Medicare prescription drug rebate requirements to prescription drugs that are available under private health insurance. Current law requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for brand-name drugs without generic equivalents under Medicare that (1) cost $100 or more per year per individual, and (2) for which prices increase faster than inflation. Manufacturers that fail to comply are subject to civil penalties. The bill applies these requirements to prescription drugs that are available in the commercial market under private health insurance. It also indexes rebate calculations to drug prices in 2016 (as opposed to 2021).
An Act Prohibiting The Marketing Of Opioid Drugs And Distribution Of Samples Of Such Drugs.
Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 This bill relaxes certain requirements for compounding drugs that are facing shortages. Drug compounding is the process of mixing or otherwise altering drugs to create a medication. Currently, the Food and Drug Administration (FDA) allows for drug compounding subject to certain requirements. Generally, a licensed pharmacist or physician not registered with the FDA may only compound drugs in limited quantities for prescriptions for a specific individual patient. On the other hand, an FDA-registered outsourcing facility may compound drugs in bulk for use in medical facilities but is subject to additional requirements. This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for an urgent medical need not involving a specific patient if, among other requirements (1) the prescriber certifies that the prescriber is unable, despite reasonable attempts, to obtain certain related drugs with the same active ingredient and route of administration; (2) the compounded drug meets certain labeling requirements, including an indication that the compounded drug is provided only for urgent administration to a patient; and (3) the compounder requests and maintains certain records about patients receiving the compounded drug. Furthermore, a restriction against an unregistered compounder regularly compounding (or compounding inordinate amounts of) what is essentially a copy of a commercially available drug shall not apply if the drug is on a shortage list maintained by the FDA or the American Society of Hospital Pharmacists.
Lower Drug Costs for Families Act This bill applies certain Medicare prescription drug rebate requirements to prescription drugs that are available under private health insurance. Current law requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for brand-name drugs without generic equivalents under Medicare that (1) cost $100 or more per year per individual, and (2) for which prices increase faster than inflation. Manufacturers that fail to comply are subject to civil penalties. The bill applies these requirements to prescription drugs that are available in the commercial market under private health insurance. It also indexes rebate calculations to drug prices in 2016 (as opposed to 2021).
Relating to drugs; providing that this Act shall be referred to the people for their approval or rejection.