This legislation, titled the "Preserve Access to Affordable Generics and Biosimilars Act," aims to enhance competition in the pharmaceutical market and lower drug costs by prohibiting certain anticompetitive agreements. Congress finds that while generic drugs and biosimilars are crucial for affordability, "reverse payment" settlements have subverted the intent of laws designed to facilitate their early entry. The bill specifically targets agreements between brand name drug companies and generic or biosimilar manufacturers that resolve patent claims but include compensation to the generic or biosimilar company in exchange for delaying market entry. Such agreements are deemed to have anticompetitive effects and are treated as an unfair method of competition under the Federal Trade Commission Act. A key provision establishes a presumption of anticompetitive effects if a generic or biosimilar applicant receives anything of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales for any period. This presumption can be overcome if parties demonstrate the value is solely for other goods or services, or that the procompetitive benefits of the agreement outweigh its anticompetitive effects. The Federal Trade Commission (FTC) is granted authority to bring civil actions against violators, seeking civil penalties and injunctive relief. Penalties can be up to three times the value received by the violating party, or three times the value given to the generic/biosimilar filer, and are intended to deter such practices. The bill outlines specific exclusions from the prohibition, ensuring that legitimate settlements are not penalized. These include agreements that grant the right to market a product before patent expiration, payments for reasonable litigation expenses (up to $7.5 million, adjusted annually), or a covenant not to sue for patent infringement. Furthermore, the legislation amends existing law to require the certification of all relevant agreements, including oral agreements, to the Assistant Attorney General and the FTC. This certification must attest to the completeness and accuracy of the filed agreement details. Violations of the new prohibitions can also lead to the forfeiture of a generic drug's 180-day exclusivity period. The FTC's litigation authority is expanded to enforce these new provisions, and a six-year statute of limitations is set for enforcement proceedings. Overall, this Act seeks to prevent pharmaceutical companies from using financial incentives to suppress competition, thereby promoting timely access to more affordable generic and biosimilar medications for consumers.