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SACRAMENTO—California Attorney General Edmund G. Brown Jr. today announced a record $62 million multi-state settlement with Eli Lilly and Company for improperly marketing the antipsychotic drug Zyprexa for use beyond the drug’s Food and Drug Administration (FDA)-approved uses.
“Eli Lilly put profits ahead of patients when it marketed Zyprexa for a use that had not been properly tested or approved, in many cases, putting young people at risk for weight gain, hypoglycemia and even diabetes,” Attorney General Brown said.
The settlement is the largest ever multi-state consumer protection-based pharmaceutical settlement. California will receive $5.6 million, the largest share of the award.
In his original complaint, Attorney General Brown alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for off-label uses and failed to adequately disclose the drug’s potential side effects to healthcare providers. As a result of the settlement, Eli Lilly agreed to change its marketing strategies and to cease promotion of its “off-label” uses. Off-label uses are those not approved by the FDA when it approves the sale and use of a particular drug. Physicians are allowed to prescribe drugs for off-label uses, but federal law prohibits pharmaceutical manufacturers from marketing products for off-label uses.
Zyprexa is the brand name for the prescription drug olanzapine. In 1996, Zyprexa was first marketed for use in adults with schizophrenia and belongs to a class of drugs commonly referred to as “atypical antipsychotics,” which are traditionally used to treat schizophrenia. 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 carries serious side-effects, including weight gain, hyperglycemia and diabetes.
Beginning in 2001, Eli Lilly launched an aggressive marketing campaign called “Viva Zyprexa!” As part of the campaign, the company marketed Zyprexa for off-label uses including pediatric care, high-dosage treatment, treatment of symptoms rather than diagnosed conditions and treatment of elderly patients suffering from dementia.
Stipulations in the settlement agreement require Eli Lilly to:
• Refrain from making any false, misleading or deceptive claims regarding Zyprexa.
• Require its medical staff, rather than its marketing staff, to have ultimate responsibility for developing and approving content for all medical letters and references 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.
• Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a healthcare provider regarding Zyprexa.
• Contractually require continuing medical education providers to disclose Eli Lilly’s financial support of their programs and any financial relationship with faculty and speakers.
• Provide a list of healthcare provider promotional speakers and consultants who were paid more than $100 for promotional speaking and/or consulting by Eli Lilly.
• Only provide product samples of Zyprexa to healthcare providers whose clinical practice is consistent with the product’s current labeling.
Other states included in today’s settlement agreement include: Alabama, Arizona, Delaware, District of Columbia, 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 and Wisconsin.