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States Reach Landmark $62 Million Settlement with Eli Lilly

[ Return To Senator Roy Dyson's Newsletter ]

Posted on October 21, 2008:

Senator Dyson Eli Lilly agrees to cease "off-label" marketing of Zyprexa

BALTIMORE (Oct. 20, 2008) - Attorney General Douglas F. Gansler announced on Oct. 9 that he, along with Attorneys General from 31 other states and the District of Columbia, entered into a settlement agreement with Eli Lilly and Company concerning the antipsychotic drug Zyprexa. It is the largest ever multi-state consumer protection-based pharmaceutical settlement.

In a complaint filed on October 7, 2008, in the Circuit Court for Baltimore City, Attorney General Gansler alleged that Eli Lilly engaged in unfair or deceptive trade practices when it marketed Zyprexa for off-label uses and when it failed to adequately disclose the drug's potential side effects. In the Consent Judgment that was also filed on October 7, 2008, in the Circuit Court for Baltimore City, Eli Lilly 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).

"This settlement will promote safer prescriptions practices by prohibiting Eli Lilly from marketing a drug which has serious side effects for uses that have not been approved by the FDA," said Attorney General Gansler.

Zyprexa, the brand name for the prescription drug olanzapine, was first marketed for use in adults with schizophrenia in 1996. Since then, the FDA has approved Zyprexa for the treatment of acute mixed or manic episodes of bipolar I disorder and for maintenance treatment of bipolar disorder. Zyprexa has been associated with serious side effects, including a high risk of weight gain, hyperglycemia, and diabetes.

Eli Lilly engaged in an aggressive marketing campaign that included promoting Zyprexa for a number of off-label uses, such as for pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and in the elderly for the treatment of patients suffering from dementia. While a physician is allowed to prescribe drugs for off-label uses, pharmaceutical manufacturers are prohibited by law from marketing their products for off-label uses.

The settlement mandates that Eli Lilly refrain from making any false, misleading or deceptive claims regarding Zyprexa. In addition, for a six-year period extending beyond the original patent term for Zyprexa, Eli Lilly shall:

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

-- Require its medical staff, rather than its marketing staff, t-- have ultimate responsibility for developing and approving the medical content of all medical letters and medical references regarding Zyprexa;

-- Provide specific, accurate, objective and scientifically balanced responses t-- unsolicited requests for off-label information from health care providers regarding Zyprexa;

-- Disclose information about grants, including continued medical education, on its website (www.lillygrantoffice.com) for at least tw-- years;

-- Not use grants t-- promote Zyprexa, or condition continued medical education funding on Eli Lilly's approval of speakers or program content;

-- Require continuing medical education providers t-- disclose Eli Lilly's financial support of their programs and disclose any financial relationship with faculty and speakers;

-- Only provide product samples of Zyprexa t-- a health care provider whose clinical practice is consistent with the product's current labeling; and

-- Register clinical trials and submit results as required by federal law and on a publicly accessible website.

Source: Attorney General Douglas F. Gansler

[ Return To Senator Roy Dyson's Newsletter ]

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