Faster Generic Drug Access: Stopping Pharma Tactics to Delay Cheaper Medicines.
This law aims to speed up the market entry of cheaper generic drugs by preventing pharmaceutical companies from misusing FDA citizen petitions as a delay tactic. It establishes clear criteria for the FDA to determine if a petition is submitted primarily to delay generic approval, which should lead directly to lower prescription costs for consumers. The FDA is also required to refer cases of intentional delay to the Federal Trade Commission (FTC) for potential enforcement action.
Key points
Limits the ability of drug companies to block cheaper generic medicines using petitions filed with the FDA.
The FDA can deem a petition a deliberate delay if it lacks data, is filed too late, or repeats previously rejected arguments.
Requires petitioners to file with the FDA within 180 days of knowing the relevant information before they can file a lawsuit to delay drug approval.
The FDA must refer instances of deliberate delay to the Federal Trade Commission (FTC) for potential antitrust action.
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