GlaxoSmithKline Agrees to Pay $3 Billion over Avandia Marketing

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On November 3, 2011, GlaxoSmithKline (GSK) agreed to a settlement with the U.S. Department of Justice (DOJ) for a record-breaking $3 billion. The settlement, which is expected to be finalized in early 2012, involves multiple civil and criminal claims filed against GSK for the alleged off-label marketing of its widely controversial diabetes drug Avandia. In particular, the government alleged that GSK had illegally marketed Avandia for uses that were not approved in the products labeling.

The governments prohibition of “off-label” marketing, or promoting a drug for uses other than those approved by the U.S. Food and Drug Administration (FDA), is a highly-contentious issue. While it is widely accepted that licensed practitioners may prescribe drugs for uses other than those approved by the FDA, drug manufacturers are prohibited from marketing such uses, even where the new uses show no signs of adverse events. However, although the FDA views its prohibition on off-label promotion as well-settled, challenges by drug manufacturers have called the legal grounding of this prohibition into question. Recently, various pharmaceutical manufacturers have brought challenges against the FDA regarding restrictions on off-label promotions, arguing that the prohibition violates the First Amendment. In addition, as previously reported, drug manufacturers petitioned the FDA in July 2011 requesting that the Agency solidify its stance on off-label marketing by promulgating regulations and publishing other guidance in this area.

For more information on FDA regulations and acceptable pharmaceutical marketing practices please contact us at contact@fidjlaw.com.