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Do Drugmakers Use An FDA Safety Program To Thwart Generics?



7/24/2014 8:40:13 AM

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Are brand-name drug makers hiding behind a mandated safety program to thwart aspiring generic rivals?

This question is at the heart of several lawsuits in which generic drug makers have accused brand-name drug makers of exploiting an FDA program known as Risk Evaluation and Mitigation Strategies, or REMS, which are designed to boost safety. The FDA often requires drug makers to develop such a plan when a drug is approved for use. Typically, these plans educate physicians and monitor distribution.

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