Bill > S1095

This bill aims to prevent pharmaceutical companies from using "sham" citizen petitions to delay the approval of generic drugs or biosimilars. Specifically, the Stop STALLING Act empowers the Federal Trade Commission (FTC) to take civil action against entities that file petitions primarily designed to obstruct competition rather than raise legitimate public health concerns. A petition would be considered a "sham" if it is objectively baseless and attempts to interfere with a competitor's business through the governmental process. If the Secretary of Health and Human Services determines a petition was submitted to delay drug approval and refers this to the FTC, the agency can pursue legal action. Potential penalties include a civil fine of either the revenue earned from the drug during the review period or $50,000 per calendar day the petition was under review, whichever is greater. The bill applies to all covered petitions submitted after its enactment and does not limit the FTC's existing legal authorities. By targeting these delaying tactics, the legislation seeks to foster faster market entry for generic medications and promote competition in the pharmaceutical industry.

Justice

https://www.congress.gov/bill/119th-congress/senate-bill/1095/all-info