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November 4, 2011

Drug Companies Seek End of Off-Label Marketing Ban

Drug companies are mounting a legal campaign to overturn longstanding U.S. regulations prohibiting them from pitching medicines for uses not listed on the bottle, The Wall Street Journal reports. Doctors routinely prescribe drugs for situations in which the meds haven’t been federally approved—usually because the drugs aren’t believed as effective or their outcomes haven’t been properly studied. Despite this common off-label practice, drug companies can’t market the meds for those non-approved uses. One example: Par Pharmaceutical Inc. has said in a court filing it wants to market Megace—a drug approved to treat AIDS-related weight loss—at long-term care facilities that also have cancer and geriatric patients. Fifteen of 31 drug cases settled under the False Claims Act from 1996 through 2010 totaling $8.7 billion involved off-label or fraudulent marketing and the related charge of misbranding.

To read the WSJ article, click here.

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