This bill adds a new section to the Federal Trade Commission Act that makes certain kinds of "product hopping" by drug or biological product manufacturers an unfair method of competition. It defines terms such as generic drug, biosimilar, reference product, follow-on product, hard switch, and soft switch. The bill says a manufacturer is prima facie (considered) to have engaged in unlawful product hopping during a specific period after a generic or biosimilar applicant files if the manufacturer either (A) performs a hard switch (for example, withdrawing or discontinuing the older product in a way that impedes competition and selling a follow-on product) or (B) performs a soft switch (taking actions that disadvantage the older product while selling a follow-on product). The bill lists narrow exclusions for truthful promotion and stopping promotion. It allows manufacturers to justify their actions to the FTC or a court for patient safety, unavoidable supply disruptions, or legitimate pro-competitive reasons. The FTC may investigate, bring administrative proceedings, seek temporary or permanent injunctions, and sue in district court for equitable remedies including disgorgement and restitution. The bill allows judicial review of final FTC orders in certain courts and allows the FTC to write rules to define terms. It applies to conduct and proceedings after the date the bill becomes law and does not replace existing antitrust laws.
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The bill’s text states its purpose is to prohibit product hopping and to give the Federal Trade Commission tools to address actions by manufacturers that impede competition from generic drugs or biosimilars. It creates a legal framework for identifying hard and soft switches and for the FTC to seek remedies.
No publicly available information.