Information on the Attorney General's Action Against Zyprexa

1. What should people who are currently taking Zyprexa do?

f you are currently taking Zyprexa and have any concerns, contact your prescribing physician. The settlement only ensures that your doctor providing the prescription has the most information available about the drug.

2. Explain what the settlement means to Indiana.

The settlement ensures that Eli Lilly will not promote or market Zyprexa in a deceptive or misleading way.

It also protects Indiana consumers who might take the drug by ensuring that the doctors prescribing Zyprexa are given accurate, objective and balanced information about the drug from Eli Lilly’s medical organization rather than from Eli Lilly’s sales, marketing or other non-medical organization.

3. How does the settlement affect Eli Lilly?

The settlement requires Eli Lilly to market and sell Zyprexa truthfully and legally. It will serve as a deterrent to prevent Eli Lilly’s off-label marketing of Zyprexa in the future, and should also serve similarly as a deterrent for Eli Lilly and other pharmaceutical companies practices with other drugs.

The settlement was negotiated by capable parties on both sides, and both the states and Eli Lilly have determined that their respective interests are best served by the settlement.

4. Will the settlement result in employee cut backs at Eli Lilly?

The settlement does not prevent Eli Lilly from marketing and selling Zyprexa truthfully and legally.

5. What are the components of the settlement?

Promotional Activities

• Cannot make any false, misleading or deceptive claims regarding Zyprexa.
• Cannot promote Zyprexa using selected symptoms of the FDA-approveddiagnoses unless certain disclosures are made regarding the approved diagnoses.

Dissemination of Medical Information

• Must require its medical staff to have ultimate responsibility for developing and approving the medical content for all medical letters and medical references regarding Zyprexa, including those that may describe off-label information.
• Must provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a health care provider regarding Zyprexa.
• Must require its medical staff to be responsible for the identification, selection, approval and dissemination of article reprints containing more than an incidental reference to off-label information regarding Zyprexa, and that such information not be referred to or used in a promotional manner;

Continuing Medical Education (CME) and Grants

• Disclose information about grants, including continued medical education on its Web site (www.lillygrantoffice.com), for at least two years and maintain the information for five years;
• Cannot use grants to promote Zyprexa, or condition CME funding on Eli Lilly’s approval of speakers or program content;
• Must contractually require continuing medical education providers to disclose Eli Lilly’s financial support of their programs and any financial relationship with faculty and speakers;

Payments to Consultants and Speakers

• Is Required to provide a list of health care provider promotional speakers and consultants who are paid more than $100 for promotional speaking and/or consulting by Eli Lilly

Product Samples

• Can only provide product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product’s current labeling

Clinical Research

• Must register clinical trials and submit results as required by federal law; register Zyprexa Eli-Lilly sponsored Phase II, III and IV clinical trials beginning after July 1, 2005; and post on a publicly accessible Web site all Eli-Lilly sponsored Phase II, III and IV clinical trials completed after July 1, 2004.

6. What off-label uses did Eli Lilly mention in their marketing?

• Pediatric use
• Use at high dosage levels
• Treatment of symptoms rather than diagnosed conditions for which the drug was approved
• Treatment and/or chemical restraint of patients suffering from geriatric dementia. 
• Mild bipolar disorder
• Depression

7. What is the approved FDA use for Zyprexa?

The FDA has approved Zyprexa for the treatment of the symptoms of schizophrenia, and certain aspects of Bipolar disorder, specifically the treatment of acute mixed or manic episodes of Bipolar I Disorder and the maintenance treatment of Bipolar disorder.

8. Why was there an investigation launched into Eli Lilly’s sale and promotion?

Although physicians can prescribe medications for uses other than those approved by the FDA ("off-label” uses), drug companies are prohibited from promoting off-label uses. The States involved in the action learned that Lilly had promoted Zyprexa for off-label uses, and opened an investigation.

The multistate investigation began due to a combination of factors, but it was largely press-driven, specifically by the December 2006 series of New York Times articles written by Alex Berenson.

9. What was Eli Lilly doing wrong? Who specifically brought the wrong-doing to light?

The multistate investigation began due to a combination of factors, but it was largely press-driven, specifically by the December 2006 series of New York Times articles written by Alex Berenson.

In early 2001, Eli Lilly began an aggressive marketing campaign called “Viva Zyprexa!” As part of that campaign, the company marketed Zyprexa for a number of uses for which it was not approved by the FDA. 

Eli Lilly marketed Zyprexa for the following off-label uses:

• Pediatric use
• Use at high dosage levels
• Treatment of symptoms rather than diagnosed conditions for which the drug was approved
• Treatment and/or chemical restraint of patients suffering from geriatric dementia. 

Through its Viva Zyprexa! campaign and its efforts to promote Zyprexa for uses for which it was not approved by the FDA, Eli Lilly misrepresented the drug’s approved uses, its safety and its effectiveness.

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