Articles

  • Off-Label Dissemination: What the Constitution Giveth, Are the OIG and DOJ Taking Away?

    Published on January 1, 2004
    Authored by Mark DuVal
    Categorized as FDA News

    Although this may be an unusual format for expressing legal and political views, it seems appropriate to address this communiqué—call it an open letter—to each of you in a public forum. This "letter" is not intended to be a law review-like dissertation; rather it is an honest and candid assessment of where industry feels it is today, given your recent prosecutions in, among others, the TAP, AstraZeneca, Abbott, Schering-Plough, and Guidant cases.1

    While we do not condone some of the activity cited in those cases, some of the legal theories espoused trouble industry because they seem to have an intended application far beyond those cases. It as if the Office of Inspector General (OIG) and the Department of Justice (DOJ) are expressing politically their institutional distaste both for off-label prescribing and for the otherwise constitutionally-protected activity of off-label dissemination as contemplated by Judge Lamberth in the Washington Legal Foundation (WLF) case.2

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