Protecting Consumer Access to Generic Drugs Act of 2023

The Protecting Consumer Access to Generic Drugs Act of 2023 prohibits "pay-for-delay" agreements between brand-name drug manufacturers (NDA/BLA holders) and generic drug applicants (subsequent filers) that delay market entry of lower-cost alternatives. It bans arrangements where generic companies receive value from brand-name companies in exchange for limiting or delaying their development, manufacturing, marketing, or sales of generic drugs. The Federal Trade Commission will enforce these provisions as unfair or deceptive practices under existing law, with specific filing requirements for such agreements and a provision to forfeit 180-day exclusivity periods if violations occur. This legislation aims to increase competition in the generic drug market, potentially lowering drug prices for consumers.