Faster Generic Drug Access: Limiting FDA Approval Delays.
This law aims to speed up the market entry of cheaper generic drugs by changing the rules for submitting petitions to the Food and Drug Administration (FDA). It introduces new criteria allowing the FDA to reject petitions submitted primarily to delay generic approvals, which should ultimately lower medication costs for consumers. Furthermore, the law requires that all objections must first be raised with the FDA within a specific timeframe before a civil lawsuit can be filed.
Key points
The FDA gains tools to quickly reject petitions primarily intended to delay the approval of cheaper generic drugs, promoting lower medication costs.
A 180-day time limit is established for submitting petitions to the FDA after the petitioner knew the information forming the basis of the request.
Courts will dismiss lawsuits seeking to delay drug approval if the company failed to file a petition with the FDA first or if the petition was untimely.
Introduced
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