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The Impact of REMS on Generic Drug Approvals and Drug Competition

This article was originally published in RPM Report

Executive Summary

From the conception of the REMS in the FDAAA Act of 2007, Congress was concerned that giving FDA authority to impose new post-marketing controls could raise competitive issues about market access for generics. Congress was right to be concerned. Despite a specific admonition in FDAAA to prevent use of the most restrictive REMS programs to prevent new competition, strategies to extend product exclusivity have emerged and the competitive landscape has changed.

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REMS Class-Action Lawsuit Against Celgene Is First By Patients

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.

REMS Class-Action Lawsuit Against Celgene Is First By Patients

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.

REMS Use Declining, But Post-Marketing Requirements Remain

Not surprisingly, FDA is imposing REMS less frequently in the fourth year of its new post-marketing authorities. But mandatory trial requirements appear to be rising, as is the use of the most burdensome type of REMS.

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