Attorney General Steve Carter, 32 States Reach Landmark $62 Million Settlement with Indiana-based Eli Lilly

Eli Lilly pays $1.6 million to Indiana in largest multi-state consumer protection-based pharmaceutical action

INDIANAPOLIS, IN -  Attorney General Steve Carter announced today that Indiana, along with 31 other states and DC, reached a record $62 million dollar action with Indiana-based Eli Lilly and Company arising from alleged improper marketing of the antipsychotic drug Zyprexa. It is the largest ever multi-state consumer protection-based pharmaceutical action.

The Attorneys General alleged that Eli Lilly may have marketed its antidepressant drug Zyprexa for off-label uses and may have failed to adequately disclose the drug’s potential side effects to health care providers. Following a nearly two-year investigation, Eli Lilly has agreed to change how it markets Zyprexa and to cease promoting its “off-label” uses, which are not approved by the U.S. Food and Drug Administration (FDA).  

“The agreement provides Hoosiers assurance that their doctors are and will be fully informed about the potential medical impact of Zyprexa,” said Carter. “We are pleased that Eli Lilly has agreed to take measures to ensure that doctors and consumers in Indiana and throughout the nation will be provided with accurate, objective and balanced information.”

The Office of the Indiana Attorney General will receive $1,602,874 from the consumer protection-based pharmaceutical action. Money from the action will be used for consumer protection and other lawful purposes that have not been determined at this time.

In 2001, Eli Lilly began an aggressive marketing campaign called “Viva Zyprexa!” As part of that campaign, the company allegedly marketed Zyprexa for a number of off-label uses including pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions and in the elderly for the treatment and/or chemical restraint of patients suffering from dementia. While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. 

The agreement mandates that for a six year time period extending beyond the patent term for Zyprexa, Eli Lilly will:

Promotional Activities

·   Not make any false, misleading or deceptive claims regarding Zyprexa;

·   Not promote Zyprexa using selected symptoms of the FDA-approved  diagnoses unless certain disclosures are made regarding the approved diagnoses; 

Dissemination of Medical Information

·   Require its medical staff, rather than its marketing 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.  This information shall not be distributed unless certain criteria are met;

·   Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a health care provider regarding Zyprexa;

·   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;

·   Not use grants to promote Zyprexa, or condition CME funding on Eli Lilly’s approval of speakers or program content;

·   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

·   Provide each signatory Attorney General a list of health care provider promotional speakers and consultants who were paid more than $100 for promotional speaking  and/or consulting by Eli Lilly;

Product Samples

·   Only provide product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product’s current labeling;  and

Clinical Research

·   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.

Participants in the action include: Alabama, Arizona, California, Delaware, D.C., Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin

Source: Office of the Indiana Attorney General

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