Bill > S1040

This bill addresses the pharmaceutical practice known as "product hopping," where drug manufacturers make minor modifications to existing drugs to prevent generic competitors from entering the market. Specifically, the bill amends the Federal Trade Commission Act to prohibit manufacturers from engaging in "hard switches" (like withdrawing the original drug from the market) or "soft switches" (taking actions that unfairly disadvantage the original drug) when a generic or biosimilar version is seeking approval. The bill defines key terms such as "generic drug," "reference product," and "follow-on product," and establishes that manufacturers can be found in violation of unfair competition laws if they take actions to impede generic drug competition within a specified timeframe. The Federal Trade Commission (FTC) is empowered to investigate and take legal action against such practices, with potential remedies including temporary or permanent injunctions, disgorgement of unjust enrichment, and restitution. Manufacturers can defend their actions by demonstrating they would have taken the same actions regardless of generic competition or that their actions were necessary for patient safety or due to legitimate pro-competitive reasons. The bill aims to promote drug market competition and prevent pharmaceutical companies from artificially extending their market exclusivity.

Justice

https://www.congress.gov/bill/119th-congress/senate-bill/1040/all-info