Safety Controls Eyed As New Way To Block Generic Drugs

Law360, New York (April 12, 2013, 7:40 PM EDT) -- Citing a safety control program adopted by the Food and Drug Administration in 2008, brand-name drug companies have begun to claim that they can refuse to sell drug samples to competitors who need them to make generic versions, a bold move that could jeopardize the generics and biosimilars businesses.

In 2008, the FDA began requiring safety controls as a condition of approving some new drugs with potential health risks, controls known as Risk Evaluation and Mitigation Strategies. REMS differ from drug to drug, and can range...
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