A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Prompt Approval of Safe Generic Drugs Act
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.)
Updated Drug Labeling for Patient Safety Act
Updated Drug Labeling for Patient Safety Act
Preserve Access to Affordable Generics and Biosimilars Act
Interagency Patent Coordination and Improvement Act of 2023 This bill establishes the Interagency Task Force on Patents to support coordination and communication between the U.S. Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) on activities relating to patents for human drugs and biological products. The task force's duties shall include sharing information about (1) the processes of each agency, including how each agency evaluates applications (e.g., patent applications at the PTO and new drug applications at the FDA); and (2) new approvals of patents, human drugs, biological products, and new technologies. The task force must also establish a process that requires (1) the PTO to request from the FDA information relating to certain patent applications to help patent examiners carry out their duties, (2) the FDA to provide such information to the PTO, and (3) the PTO to assist the FDA in its ministerial role of listing patents.
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
Protecting Consumer Access to Generic Drugs Act of 2023
To amend the Federal Food, Drug, and Cosmetic Act to require labeling of food products containing insects, and for other purposes.