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Expert Analysis

REMS Abuse And Antitrust Injury: Round Peg, Square Hole

Law360, New York ( November 4, 2015, 12:55 PM EST) -- In recent years, a small crop of complaints have alleged that brand pharmaceutical companies take advantage of distribution restrictions in U.S. Food and Drug Administration-imposed "risk evaluation and mitigation strategy" — or REMS — programs to delay or block generic competition.[1] Recently, district courts issued motion to dismiss decisions in two such cases: Natco Pharma Ltd. v. Gilead Sciences Inc. and Express Scripts Holding Co.[2] and In re Thalomid and Revlimid Antitrust Litigation.[3]...

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