• Justice Contacts the WLF

    • Published on: March 1, 2005
    • Category: FDA News

    Update March/April 2005


    This article is comprised of three parts: a letter from the Department of Justice (DOJ) to the Washington Legal Foundation (WLF), WLF’s letter in response, and an author’s commentary in reaction to both. The letters are reprinted here from text provided to Update by the WLF legal department.

    Justice Contacts the WLF

    [The following October 5, 2004 letter was addressed to Mr. David Price, Senior Vice President, Legal Affairs, WLF.]

    Dear Mr. Price: I am writing in response to your letters of April 16, 2004 and June 15, 2004, on behalf of the [WLF], in which you express concern about the [DOJ’s] criminal and civil investigations of the promotion by pharmaceutical companies of “off-label” uses of their products.

    In your April 16 letter, you write that WLF is “concerned about recent press reports indicating that various United States Attorneys’ offices are conducting civil and criminal investigations of major pharmaceutical companies based, in part, on truthful and non-misleading speech about their products.”

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

    • Published on: January 1, 2004
    • Category: 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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