Faster Access to Affordable Medicines: Ending Approval Delays
New rules aim to speed up the market entry of cheaper generic drugs by limiting pharmaceutical companies' ability to delay the process through unjustified petitions. This means citizens may gain quicker access to more affordable medications, potentially lowering treatment costs and improving therapy availability.
Key points
The Food and Drug Administration (FDA) can deny petitions primarily intended to delay generic drug approvals.
Petitions must be submitted within 60 days of the information becoming known, limiting intentional delays.
The FDA will report to Congress on delaying petitions and their impact on drug availability, increasing transparency.
Companies submitting delaying petitions may be referred to the Federal Trade Commission (FTC).
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