Eli Lilly pays record $1.4bn for promoting off-label use of olanzapineBMJ 2009; 338 doi: http://dx.doi.org/10.1136/bmj.b217 (Published 20 January 2009) Cite this as: BMJ 2009;338:b217
The drug giant Eli Lilly has agreed to pay $1.4bn (£1bn; €1.1bn) in settlement for the marketing of its antipsychotic drug olanzapine (Zyprexa) for off-label uses. It is the largest individual corporate fine in history.
The drug, which is licensed for the treatment of schizophrenia and bipolar disorder, was widely promoted by Eli Lilly between September 1999 and November 2003 to treat more common disorders, such as dementia, agitation, aggression, depression, and sleep problems, said the US Department of Justice in a statement.
The company began its promotion by encouraging doctors who treated people in nursing homes and assisted care facilities to prescribe olanzapine, because one of the drug’s side effects is sedation. It claimed that “this side effect was a therapeutic benefit, not an adverse event.” The sales force used the slogan “5 at 5,” meaning that 5 mg of olanzapine at 5 pm would help patients sleep, said the department’s statement.
Eli Lilly expanded its “illegal” marketing strategy to primary care doctors in 2000 with the “Viva Zyprexa” campaign, whose goal, the statement said, was to make the drug “an everyday agent in primary care, even though the company recognized that schizophrenia and bipolar disorder were not viewed as conditions typically treated by primary care physicians.”
The department said that the off-label marketing campaign “raised safety issues and posed potential risk to patients.”
Eli Lilly knew that olanzapine could cause significant weight gain and obesity and increase the risk of hyperglycaemia and diabetes, “yet despite written caution from the FDA [US Food and Drug Administration], Eli Lilly continued to promote these adverse events as therapeutic benefits of Zyprexa use, particularly in the elderly.”
The statement added, “Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law, and directed its sales personnel to promote Zyprexa for off-label uses. When promoting Zyprexa to health care providers, Lilly emphasised that the weight gain of the drug was a therapeutic benefit for patients who had trouble maintaining their weight.”
Eli Lilly pleaded guilty to one misdemeanour violation of the Food, Drug, and Cosmetic Act and agreed to pay a total of $615m.
Gregory G Katsas, assistant attorney general for the civil division of the Department of Justice said, “Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining a drug is safe and effective for a particular use before it is marketed.”
In a separate civil settlement agreement Eli Lilly agreed to pay nearly $800m to the US government and to state Medicaid programmes for payment for unapproved off-label uses of olanzapine.
Four former sales representatives who blew the whistle on Eli Lilly for the off-label practices and who were either fired or resigned filed lawsuits against the company, said the Department of Justice statement. They will share $80m of the civil settlement, in a bid to encourage whistleblowers. Federal law permits whistleblowers to share in the money recovered.
Kim Rice, special agent in charge at the FDA’s Office of Criminal Investigations, said, “The unprecedented terms of this settlement demonstrate the government’s increasing efforts aimed at pharmaceutical companies that choose to put profits ahead of the public’s health.
“The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the safeguards of the drug approval process and recklessly promote drugs for uses for which they have not been proven to be safe and effective.”
Eli Lilly has agreed to cease off-label marketing and must send doctors letters advising them of the settlement, give them a way to report questionable conduct of sales representatives, list payment to doctors on its website, and ensure that the company complies with the law.
John C Lechleiter, chairman, president and chief executive officer of Eli Lilly, said in a statement, “We deeply regret the past actions covered by the misdemeanor plea. At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct.”
Cite this as: BMJ 2009;338:b217