GlaxoSmithKline is the latest drugmaker to pay the price for a government investigation of off-label marketing. The company said it’s taking a $400 million hit over a Justice Department investigation of the way Glaxo marketed top drugs.
Glaxo said it would take the charge in its fourth-quarter results due to an investigation initiated by the U.S. attorney’s office in Colorado over “marketing and promotional practices for several products” from 1997 to 2004. Glaxo reports earnings on Feb. 5.
Glaxo didn’t specify whether it was moving toward a settlement, but said its decision to take the charge “reflects the current status of the investigation, and is based upon the company’s most recent evaluation of the matter.”
According to Glaxo’s most recent annual report, the company received a subpeona from the Colorado U.S. attorney’s office in 2004 around promotion of nine of its top-selling products. The government inquired about alleged off-label marketing as well as medical education programs for doctors, “other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment.”
Though the subpeona came from Colorado, the inquiry is “nationwide,” the filing says.
Part of the investigation concerns a response the company provided to an FDA inquiry of alleged off-label promotion of antidepressant Wellbutrin SR.
Other drug companies paying up over Justice Department probes of off-label marketing include Pfizer, which just took a $2.3 billion charge linked to allegations around painkiller Bextra, and Eli Lilly, which settled for $1.42 billion over marketing of antipsychotic Zyprexa.
The Colorado U.S. attorney’s office declined to comment, and a Glaxo spokeswoman declined to offer additional details.
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