GlaxoSmithKline Hit With $3 Billion Off-Label Settlement

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Drug maker GlaxoSmithKline(GSK) has to pay $3 billion while pleading guilty to federal charges. The charges are composed of a mix of criminal and civil issues that arose from the company's engaging in kickbacks, misbranding and other misconduct.

In the early part of the 2000s, GlaxoSmithKline started an off-label marketing campaign to get doctors to push medications such as Paxil and Welbutrin. The focus was to encourage physicians to prescribe the drugs for off-label use, and for conditions that they were not intended to resolve.

Paxil is licensed for the treatment of depression and other mental issues, but notes written by GSK's sales rep show that the drugs were being pushed for a variety of unapproved uses. One such push was to use them for children and adolescents. The drug maker even went so far as to sponsor dinners and spa programs for physicians.

Another GSK product, Advair, was also pushed for off-label use. Advair is an asthma medication that is used in the most serious of asthma cases. GSK instructed sales reps to promote the drug for use in all types of asthma sufferers, including those with mild cases, which Advair is not approved for. Similar promotion was encouraged for Welbutrin as a weight-loss drug.

The public at large is at the mercy of those who provide life-saving and enhancing medications, with the only available recourse coming through the courts. A court case cannot necessarily fix the harm that has been caused by the misuse of medications, but it can bring financial relief for those who have suffered.

Source: Los Angeles Times, "GlaxoSmithKline settles drug-marketing case for $3 billion," William D'Urso, July 2, 2012

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