It is not uncommon for large drugmakers to market drugs for uses that have not been approved by the U.S. Food and Drug Administration. This practice, known as “off-label marketing,” can result in billions of dollars in profits for drugmakers, but can also cause significant patient harm.
Abbott Laboratories recently agreed to pay federal authorities $1.5 billion because of its off-label promotion of the anti-seizure drug Depakote. The company recently pleaded guilty to marketing the dangerous pharmaceutical for unapproved uses that may have endangered customers.
Abbott’s off-label marketing activities were first brought to light by whistleblowers who alleged that the company was violating “basic norms of health care and ethics.” Approximately $800 million of the total payout is to satisfy civil lawsuits by states and the federal government. The other $700 million is to pay a criminal fine and forfeiture.
Depakote was approved as an anti-seizure and mood stabilizing drug for bipolar disorder patients. This is a limited market, however, so Abbott allegedly devised a specialized sales force designed to push the drug in nursing homes to treat dementia. This action was controversial because there is insufficient evidence that the drug is safe for these patients and the company sought to exploit a loophole in federal rules designed to prevent unnecessary pharmaceuticals from being pushed on nursing home patients.
The company also marketed Depakote to treat schizophrenia despite clinical trial evidence showing that the drug was not more effective than antipsychotic drugs.
Source: The Associated Press, “Abbott Labs agrees to pay $1.5B over Depakote,” May 7, 2012