Off-label promotion is apparently second nature to healthcare companies.
Even despite the fact that it is illegal.
Now, there may be a powerful deterrent and a signal that the federal government is cracking down on the practice more strongly than before.
Last year, the federal government collected $1.45 billion in a settlement from pharmaceutical and medical device companies, and the most common charge of alleged misconduct was off-label promotion, according to law firm Skadden. And now comes the news that Abbott Labs is going to pay $1.5 billion in fines for promoting antiseizure drug Depakote in areas outside for which it was approved. It has also pleaded guilty on a misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding.
Yes, you got that right. Last year, the entire industry paid $1.45 billion to settle all charges, including allegations of off-label promotion. This year, Abbott alone is agreeing to cough up $1.5 billion. It is the second-largest payment by a drug company and includes a “criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million” according to the DOJrelease.
“Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, deputy attorney general, in a release. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”
Here’s a portion of the release from the DOJ:
Abbott has pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved.In anagreed statement of facts filed in the criminal action, Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use.In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.
By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
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