Bill > HR2883

This bill aims to enable the Federal Trade Commission (FTC) to deter the filing of sham citizen petitions that attempt to interfere with the approval of competing generic drugs or biosimilars. The bill defines a "sham" petition as one that is objectively baseless and attempts to use a governmental process to interfere with a competitor's business. The bill allows the FTC to take civil action against individuals or entities that submit or cause the submission of such sham petitions, including by imposing civil penalties based on the revenue earned from the sale of the drug product or a daily fine for each day the petition was under review. The bill also clarifies that it does not modify or limit the applicability of antitrust laws.