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REMS Class-Action Lawsuit Against Celgene Is First By Patients

Executive Summary

Patients For Affordable Drugs Founder David Mitchell alleges Celgene's unlawful delay tactics like REMS obstruction kept generic versions of Thalomid and Revlimid off the market, forcing plaintiffs to pay higher costs.

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FDA User Fee Bill: House Cmte. Makes Technical Changes, Adds Pricing Resolution

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REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill

Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.

REMS Reform Seems Distant Goal For Generics After Limited Support At US House Hearing

Although panelists expressed concerns about REMS misuse as barrier to competition, Republicans did not appear interested in the topic.

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