New Penalties for Blocking Cheaper Generic Drug Approvals.
This law aims to speed up access to affordable generic and biosimilar drugs by curbing abusive practices. The Federal Trade Commission (FTC) gains the power to impose high penalties on pharmaceutical companies that file baseless petitions with the FDA solely to delay the market entry of cheaper, competing medicines. Citizens should benefit from faster availability of lower-cost drug alternatives, reducing healthcare expenses.
Key points
The FTC can penalize companies that intentionally delay generic drug approvals, classifying this action as an unfair method of competition.
Financial penalties are substantial: up to $50,000 for each day of delay or the equivalent of revenue earned from the drug's sale during that period.
The goal is to increase competition and lower drug prices for consumers.
Expired
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