U.S. Barred From Prosecuting Off-Label Sales of Drugs
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Pharmaceutical companies and their sales staff can’t be prosecuted for promoting drugs for “lawful,” unapproved uses, a federal appeals court said, reversing a conviction of a salesman.
Alfred Caronia, a sales representative for Orphan Medical Inc., was convicted in 2008 of conspiracy to introduce a misbranded drug into commerce by promoting the narcolepsy medication Xyrem for unapproved uses. Under the U.S. Food, Drug and Cosmetic Act, or FDCA, doctors are allowed to prescribe drugs for unapproved uses while drugmakers and their sales representatives are barred from promoting such prescriptions.