Wall Street Journal
by Jeanne Whalen
4 Nov 11
In one of the largest settlements of its kind, GlaxoSmithKline PLC said it will pay the U.S. government $3 billion to settle several long-running criminal and civil investigations into the company, including allegations that Glaxo marketed some drugs illegally and defrauded the Medicaid program.
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The deal is one of the largest in a string of settlements the U.S. government has struck with drug companies as it tries to stamp out illegal marketing practices that flourished in the 1990s and early 2000s. Critics of the industry say the sums, while large, are still dwarfed by the profits companies earned from marketing their drugs improperly. "It's a speed bump," said Kevin Outterson, co-director of the health-law program at Boston University. "It's a cost of doing business."
Glaxo has disclosed that investigators examined whether Glaxo promoted Wellbutrin for uses not approved by the Food and Drug Administration, an illegal practice known as off-label marketing.
Investigators have also examined how Glaxo portrayed, in interactions with doctors and the FDA, patients' risk of suicidal behavior while taking Paxil, according to lawyers interviewed by the investigators.
In addition, the investigation has examined Glaxo-funded medical education and clinical trials, and the company's hiring of doctors for various services, according to Glaxo disclosures.
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A number of big drug companies have struck large settlements with the U.S. in recent years to resolve similar investigations. In 2009, Pfizer Inc. agreed to pay $2.3 billion to settle a federal investigation into whether it promoted the painkiller Bextra off label. Eli Lilly & Co. agreed to pay $1.4 billion to settle similar charges involving its antipsychotic medicine Zyprexa. AstraZeneca PLC and Novartis AG also made big settlements last year relating to their marketing practices.
http://online.wsj.com/article/SB1000...100584756.html