Preserve Access to Affordable Generics and Biosimilars Act

The Preserve Access to Affordable Generics and Biosimilars Act prohibits "reverse payment" settlements where brand-name drug companies pay generic competitors to delay market entry, treating such agreements as anticompetitive violations of the Federal Trade Commission Act. The bill empowers the FTC to enforce these rules through civil penalties that can reach up to three times the value transferred in the settlement and allows for the forfeiture of a generic company's 180-day exclusivity period if they violate the new law. It also requires executives to certify that all settlement documents filed with regulators are complete and accurate, including any related oral agreements or contingent conditions. These provisions apply to both traditional generic drugs and biosimilar biological products to ensure that patent disputes do not unduly restrict consumer access to lower-cost alternatives.