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REMS And Generics: GPhA Needs Legislation, Continues Education

Executive Summary

GPhA says congressional action is only remedy after study estimates $5.4 billion in potential savings is lost annually because of brand manufacturers using REMS to prevent generic competition.

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Generic Drug Roadblock: 74 Brands Subject To REMS, Other Restrictions

Report sponsored by Association for Accessible Medicines in US says drugs with restricted distribution programs had total sales of $22.7bn in 2016; seven drugs had sales topping $1bn.

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

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