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Stopping Fake Petitions to Speed Up Generic Drug Approval

New rules aim to speed up access to cheaper generic and biosimilar drugs. The law will make it harder for pharmaceutical companies to file false petitions that delay the market entry of competitive, often cheaper alternatives. This means citizens may gain faster access to more affordable medications.
Key points
The Federal Trade Commission (FTC) gains tools to penalize companies filing baseless petitions intended to delay generic drug approval.
Companies filing such sham petitions can face significant fines, calculated based on revenues earned or a daily amount for each day of delay.
The goal is to increase competition in the pharmaceutical market, potentially leading to lower drug prices and wider availability for patients.
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Additional Information
Print number: 119_S_1095
Sponsor: Sen. Klobuchar, Amy [D-MN]
Process start date: 2025-03-24