Law360, New York (January 30, 2008, 12:00 AM ET) -- Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration ("FDA") has not approved the drug for the rare disease.
While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this "off-label" use. The drug company wants to get the word out quickly about the new use....
Criminal Prosecution Of Off-Label Drug Promotion
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