WLF Appeals Court Decision Leaves Free Speech Question Open
Executive SummaryFDA's ability to introduce sponsor dissemination of off-label reprints as evidence in enforcement action litigation may be the next item open for constitutional questioning, following the Feb. 11 dismissal of Washington Legal Foundation v. Henney by the Washington D.C. appeals court.
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A draft guidance that outlines six categories of drug ads FDA wants submitted for prior review is a violation of advertisers’ free speech rights, the industry group argues. Other comments float a storyboard compromise.