Bill > S1096

This bill seeks to prohibit anticompetitive practices in the pharmaceutical industry, specifically targeting "reverse payment" settlement agreements between brand name drug manufacturers and generic drug or biosimilar product manufacturers. These agreements, which involve brand name companies paying generic companies to delay entering the market, have historically prevented low-cost generic and biosimilar drugs from becoming available to consumers. The bill amends the Federal Trade Commission Act to create a presumption that such settlements have anticompetitive effects, with potential civil penalties up to three times the value received from the agreement. Key provisions include requiring companies to file detailed certifications about settlement agreements, creating mechanisms for the Federal Trade Commission to challenge these agreements, and establishing that such settlements can result in forfeiture of certain market exclusivity rights. The legislation aims to enhance competition in the pharmaceutical market, support antitrust principles, and ultimately lower drug costs for consumers by preventing brand name drug companies from artificially extending their market monopolies. The bill applies to both traditional generic drugs (filed through Abbreviated New Drug Applications or ANDAs) and biosimilar biological products, which represent a growing and expensive segment of the pharmaceutical market.

Justice

https://www.congress.gov/bill/119th-congress/senate-bill/1096/all-info