Regulatory Focus™ > News Articles > GSK Settles Charges, Agrees to Record-Setting Fine

GSK Settles Charges, Agrees to Record-Setting Fine

Posted 03 July 2012 | By Alexander Gaffney, RAC 

British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used to promote three of its best-selling drugs.

In a statement released 2 July, US Department of Justice (DOJ) officials said GSK plead guilty to three counts of criminal conduct, including respective counts of misbranding antidepressants Paxil (paroxetine) and Wellbutrin (bupropion). A final count alleged the company "failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends."

"The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators' concerns about the cardiovascular safety of Avandia," DOJ wrote in its statement. The failure to disclose the data resulted in a $242 million fine for the company, which has already seen its Avandia product become the subject of two "black box" warnings for congestive heart failure and myocardial infarction.

As part of the settlement, GSK also paid $757 million to settle its charges related to Wellbutrin. DOJ alleged the company paid millions to doctors to promote the off-label uses of the drug in addition to "sham advisory boards and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for [unapproved] uses."

The remaining funds-approximately $2 billion, which would by itself be among one of the largest fines in US history for healthcare misconduct-were the result of GSK's marketing of several other drugs, including Paxil. DOJ alleged GSK's behavior effectively combined the tactics used to market Paxil and Wellbutrin, both withholding data regarding the drug's efficacy while using illicit promotional tactics to market the product.

Other violations included in the fine included Advair, Malictal and Zofran, all of which were marketed "for uses not approved by [FDA]," wrote DOJ.

As part of the settlement, GSK will be subject to a Corporate Integrity Agreement (CIA) administered by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) which DOJ said includes "novel provisions that require that GSK implement and/or maintain major changes to the way it does business, including changing the way its sales force is compensated to remove compensation based on sales goals for territories."

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