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Allergan Inc. Message Board

  • stocktracker2008 stocktracker2008 Sep 1, 2010 1:45 PM Flag

    $600 million fine for misbranding- more coming?

    How is it that Latisse marketing is not also "misbranding" as most use is cosmetic not for the rare disease that it was approved, Treatment for Hypotrichosis, which occurs in less than 1 in 2000?

    Allergan Inc (NYSE:AGN )has agreed to plead guilty and pay $600 million to resolve a federal probe of its marketing practices for the injectable wrinkle smoother Botox, the company and the Department of Justice said on Wednesday. Allergan will record nonrecurring pretax charges of $610 million to $615 million in its third fiscal quarter related to the settlement.
    Worldwide sales of Botox were $691 million for the first half of 2010 for both therapeutic and cosmetic uses, although the settlement only involves its non-cosmetic version.
    As part of the settlement, the company will plead guilty to a single misdemeanor "misbranding" charge covering the period 2000 through 2005, and pay $375 million in criminal penalties and forfeiture, the Justice Department said.
    News of the agreement sent Allergan shares up almost 3 percent and is the latest settlement involving the misbranding of drugs by pharmaceutical companies. Pfizer agreed to pay $2.3 billion in a similar case.
    "For nearly a decade Allergan illegally promoted Botox for uses that were not approved as safe and effective by the FDA (Food and Drug Administration)," said Tony West, assistant attorney general for the Justice Department's civil division.
    He said the department would continue to "aggressively pursue" such cases and the Allergan case served as a deterrent in the industry.
    The DOJ accused Allergan of a concerted effort to promote Botox for certain therapeutic uses not approved by the FDA, paying kickbacks to encourage doctors to prescribe it and teaching them how to bill for off-label uses.
    Allergan also agreed to pay $225 million to resolve civil claims asserted by the Justice Department under the civil False Claims Act. The company will also enter into a corporate monitoring program that will include publicly detailing payments to doctors

171.15-1.28(-0.74%)10:13 AMEDT

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