Pharmaceutical giant Eli Lilly pled guilty to criminal charges that it urged doctors to prescribe its anti-psychotic drug, Zyprexa, for uses not approved by the U.S. Food & Drug Administration (FDA). The drug manufacturer was fined $615 million for its conduct.
Zyprexa Use
Eli Lilly’s Zyprexa is an anti-psychotic drug that has been approved by the FDA for treating the symptoms of schizophrenia, acute mixed or manic episodes of bipolar I disorder and for maintenance treatment in bipolar disorder. However, the company urged doctors to prescribe the drug for other, off-label, uses such as treatment in children and treatment of the elderly for dementia and depression. Zyprexa has been prescribed to nearly 24 million people in 84 countries since its approval in 1996. Worldwide sales were over $4.8 billion in 2007.
“Viva Zyprexa”
That was the name of Lilly’s sales campaign to have doctors use Zyprexa for unapproved uses. However, the company’s scheme came back to haunt them. It has agreed to pay approximately $1.4 billion in fines, damages and penalties to settle several whistleblower lawsuits brought by former employees of the company. The lawsuits alleged that the company defrauded Medicare, Medicaid and other health care programs in connection with Zyprexa. Part of that figure also represents the $615 million fine for urging doctors to prescribe Zyprexa for off-label uses – and providing them with kickbacks for their actions.
Is Eli Lilly a recidivist?
That’s what the judge in the case called the drug maker. Being called a habitual law breaker by the judge who approves $1.4 billion in damages simply can’t be good for business – especially after the company was recently accused of lying to the FDA about Zyprexa’s link to diabetes.
Legal experts say that the judge in the case did not want to put the company out of business, but wanted to send a strong message for it to stop its illegal activity. In addition to the monetary fine, Lilly’s actions will now be monitored by the U.S. Department of Health and Human Services’ Inspector General to make sure the company complies with federal laws.