Regulatory Focus™ > News Articles > Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing

Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing

Posted 08 May 2012 | By Alexander Gaffney, RAC 

Pharmaceutical manufacturer Abbott Laboratories has agreed to pay a near-record $1.5 billion in fines for the off-label promotion of its anti-seizure drug Depakote, with the total to be split between the federal government, states and consumers.

In a lengthy statement released by the Department of Justice (DOJ), Deputy Attorney General James M. Cole called the settlement a "strong message to other companies" not to engage in fraud.

DOJ explained in its statement that Abbott executives had agreed to market Depakote for a wide range of indications not approved by the US Food and Drug Administration (FDA).

"In an agreed 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," wrote DOJ in their statement. "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."

As part of the agreement, Abbott will be subject to a corporate integrity agreement (CIA) to ensure the company remains in compliance.

"The five-year CIA requires, among other things, that Abbott's board of directors review the effectiveness of the company's compliance program, that high-level executives certify to compliance, that Abbott maintain standardized risk assessment and mitigation processes, and that the company post on its website information about payments to doctors," explained DOJ. Failure to comply with the CIA will subject Abbott to the possibility of being excluded from federal programs, including Medicare and Medicaid.

The settlement is reportedly one of the largest ever, behind only Pfizer's $2.3 billion fine for marketing Bextra and GlaxoSmithKline's $3 billion settlement over its marketing of Avandia, reports The New York Times.


Read more:

DOJ - Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote

DOJ - Acting Associate Attorney General Tony West Speaks at Press Conference Regarding Settlement with Abbott Laboratories

The New York Times - Abbott Settles Marketing Lawsuit

NPR - Abbott Labs To Pay $1.5B Over Anti-Seizure Drug

Modern Healthcare - Abbott to pay $1.5 billion settlement

Thompson Reuters - Abbott Depakote Settlement Totals $1.5 Billion

NASDAQ - 2nd UPDATE: Abbott To Pay $1.6 Billion To Settle Depakote Marketing Probes

Pharmalot - Abbott To Pay $1.6 Billion To Settle Depakote Probes

$1.5B Abbott fine proves Feds serious about penalizing off-label promotion

Pharma Times - Abbott pays $1.6 billion to settle Depakote investigation

Forbes - In Latest Drug Sales Case, Abbott Will Pay $1.5 Billion

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe