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US SB1040
Bill
AI Summary
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Amends the Federal Trade Commission Act to prohibit pharmaceutical "product hopping," where brand-name drug manufacturers impede generic or biosimilar competition through anticompetitive product switches
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Defines two types of prohibited conduct: "hard switches" (withdrawing original drugs from the market while selling reformulated versions) and "soft switches" (taking actions that unfairly disadvantage original products relative to follow-on products)
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Applies during the period from when a manufacturer receives notice of a generic/biosimilar application until 180 days after the competing product enters the market or 3 years after the follow-on product launches
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Provides manufacturers an affirmative defense if they can demonstrate actions were taken for patient safety reasons, due to supply disruptions beyond their control, or for legitimate pro-competitive reasons
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Grants the FTC enforcement authority including temporary and permanent injunctions, disgorgement of unjust enrichment, and restitution, with a 5-year limitations period for seeking monetary remedies
Legislative Description
Drug Competition Enhancement Act
Health
Last Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
4/10/2025