GlaxoSmithKline to Pay $3B for Drug Labeling
GlaxoSmithKline (GSK) will reportedly pay $3 billion to resolve criminal and civil claims of illegal marketing practices relating the drugs Avandia, Paxil, and Wellbutrin. GSK has been accused of marketing the depression drugs Paxil and Wellbutrin for unapproved uses and failing to report clinical data about the diabetes drug Avandia.
A 7-Year Investigation
- The deal would mark the end of a seven-year investigation into GSK for illegal marketing practices.
- The investigation began in 2004 in Colorado and was then taken over by the U.S. Attorney in Massachusetts.
- The company was under investigation for marketing drugs for unapproved uses and for influencing doctors to promote the drugs for off-label uses.
Allegations Against GlaxoSmithKline
- Failure to provide safety data about Avandia from 2001 to 2007.
- Promoting Paxil for the treatment of depression in patients under 18-years-old (an unapproved use).
- Promoting Wellbutrin for unapproved uses such as weight loss, sexual dysfunction, and substance abuse.
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