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Case Detail


In re: Revised Draft Guidance on Distributing Publications on Off-Label Uses
On May 15, 2014, WLF filed formal comments with FDA, warning the agency that it would violate the terms of a federal court injunction were it to adopt its revised draft guidance on reprint practices regarding articles/medical texts that contain off-label information concerning FDA-approved products. WLF reminded FDA that a federal court injunction (issued in 1998 in Washington Legal Found. v. Friedman) prohibits FDA from preventing manufacturers from disseminating peer-reviewed medical journal articles and medical texts that contain truthful off-label information. It asserted that FDA officials could be held in contempt of court if they attempt to enforce speech restrictions outlined in the Draft Guidance. WLF also argued that disseminating information about effective off-label uses serves a vial health care function, and that the information is unlikely to reach doctors without manufacturer involvement.
Case Status:
Awaiting FDA response.
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