• The last drug company settlement for off-label promotion

    Glaxo settled with the USG this week (WSJ), agreeing to pay $3 billion on charges of off-label promotion and several other issues.  (For general background on these suits, see Kesselheim, Mello & Studdert in PLoS Medicine 2011)

    • Compared to Glaxo US revenues during the settlement period, this is a mere “speed bump” for them, akin to parking tickets for UPS or any other cost of doing business. Total off-label promotion settlements for all companies has been about $12 billion the last 15 years, averaging less than a billion per year.  Annual US sales, about $350 billion.
    • This will be one of the last US drug company settlements for off-label marketing. As previously discussed here at TIE, after Sorrell v. IMS Health, the companies will defend off-label marketing on First Amendment grounds. In a separate article, the WSJ discusses this today.
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    • So, the reality is that some of these drugs actually WORK in off-label conditions. There was a major settlement between the drug manufacturers and Medicaid for promotion of off-label use, when the label was subsequently amended, after FDA review, to include that use. What matters is “is the drug effective for this condition?” Not “has the FDA already agreed to the efficacy?”

    • There is more at stake than just whether the drug works for the off-label use in any given instance. If we allow drug companies to use to promote their drug for any use then we are allowing them to simply prove to the FDA it meets one indication to get on the market, and everything else it’s promoted for (no matter how dangerous) would be allowed without rigorous testing. See Marc J. Scheineson’s comments in this NYT article on the First Amendment and promotion drugs http://www.nytimes.com/2009/10/03/business/media/03drug.html

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