This past week, according to the Associated Press, the agreement was announced by Illinois-based Abbott Laboratories to pay $1.5 billion in criminal fines, civil settlements and forfeiture. Abbott pled guilty to promoting the anti-seizure medication, Depakote, for uses which had not been approved by the U.S. Food and Drug Administration (FDA). The Washington Post article by N.C. Aizenman of May 7, 2012, announced the settlement as $1.6 billion.[1] According to Aizenman, this is “the second-largest in a string of multimillion-dollar payouts in recent years.” (Pfizer’s $2.3 billion settlement in 2009 is so far, the largest.)[2] Whatever the dollar amount beyond a billion, Deputy Attorney General James Cole noted that this settlement represented efforts by the U.S. Government “to hold accountable those who commit fraud.”[3] Abbott said they’re pleased the matter is resolved.
The company’s strategy, according to the Associated Press’ syndicated column of May 8, 2012, in The Daily News Record, was at fault; and it was a top-down strategy involving high-level executives who sanctioned and promoted the aggressive marketing of Depakote for uses for which it had not been approved, including to treat schizophrenia, agitated dementia and autism.
Abbott admitted having trained its sales force to sell Depakote to treat dementia, to sedate patients in nursing home settings, because the drug did not come under the umbrella of federal regulations which would have prevented “the use of unnecessary medications”[4] in nursing homes. While a physician can prescribe a drug generally designated for a different purpose, a company cannot market a drug for a purpose for which it has not been approved by the FDA.
Whistleblowers brought Abbott’s practices to the attention of federal investigators. Abbott Labs says, “It takes its responsibility to patients and health care providers seriously.”[5] It is our opinion, at that price tag it should do so.
[1] Abbott Labs Agrees To Pay $1.6 Billion Over Illegal Marketing of Depakote, Aizenman, N.C., The Washington Post, May 7, 2012, http://www.washingtonpost.com/national/health-science/abbott-laboratories-agrees-to-16-billion-settlement-over-marketing-of-depakote/2012/05/07/gIQAh5098T_story.htm
[2] Op.Cit.
[3] “Abbott Labs Agrees To Pay $1.5 Billion Settlement”, Associated Press, May 8, 2012, The Daily News Record, Harrisonburg, Va.
[4] Op. Cit.
[5] Ibid.
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