Drug Cos. Faulted For Not Giving FDA Risky-Drug Info

Law360, New York (February 13, 2013, 8:31 PM EST) -- Pharmaceutical companies are not providing the U.S. Food and Drug Administration with enough information to ensure high-risk drugs are providing more benefits than harm to users, a government watchdog said Tuesday.

The U.S. Department of Health and Human Services' Office of Inspector General released a report examining drugmakers' adherence to risk evaluation and mitigation strategies, or REMS. The FDA Amendments Act of 2007 gave the FDA the power to require REMS for drugs and biological products whose health risks might outweigh their benefits without the precautionary...
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