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

 
• By Brenda Sandburg

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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The US generic drug industry has long complained that brand-name pharma companies are using Risk Evaluation and Mitigation Strategy (REMS) programs to limit access to drugs for generic bioequivalence testing. Now they have the numbers to show the economic impact.

A June 7 report sponsored by the Association for Accessible Medicines, formerly the Generic Pharmaceutical Association, analyzed REMS and other programs restricting distribution of drugs and found that they cover 74 drugs with total sales of $22.7bn in 2016

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