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Case Detail


In re Reprints Guidance
(Regulatory Proceeding)
On April 21, 2008, WLF filed formal comments with the Food & Drug Administration (FDA) in opposition to FDA's draft Guidance for Industry on reprint practices regarding articles/medical texts that contain off-label information concerning FDA-approved drugs and medical devices. WLF reminded FDA that a federal court injunction (issued in 1998 in WLF v. Friedman) prohibits FDA from preventing manufacturers from disseminating peer-reviewed medical journal articles and medical texts that contain off-label information. WLF charged that the Draft Guidance violates the injunction and that FDA officials would be in contempt of court were they to adopt the Draft Guidance in final form. WLF argued that if FDA intends to go forward with new restrictions on manufacturer speech, it must revise them to ensure that they violate neither the injunction nor the First Amendment. WLF also argued that disseminating information about effective off-label uses serves a vital health care function.
Case Status:
Awaiting decision.
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