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Bill to stop citizen petition “abuse”

This article was originally published in The Tan Sheet

Executive Summary

Sens. Herb Kohl (D-Wis.) and Patrick Leahy (D-Vt.) introduced a proposal to prohibit drug manufacturers from using FDA's citizen petition review process simply to block generic competitors from reaching the market. Although most citizen petitions relating to generic versions of drugs affect the prescription arena, over-the-counter manufacturers can also use this gambit to prevent generic competitors from reaching the market. The "Citizen Petition Fairness & Accuracy Act of 2006," would authorize HHS to sanction companies who abuse the citizen petition process. Proposed sanctions include fines up to $1 mil., suspensions or permanent revocations of violators' rights to file future petitions and dismissals of petitions. The bill would also require HHS to review all citizen petitions within six months of filing...

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