TALLAHASSEE, FL LawFuel – Online Legal Jobs & Legal Announcements – Attorney General Bill McCollum announced today that Florida and 32 other states have reached a record-setting $62 million settlement with Eli Lilly and Company over allegations the company improperly marketed the prescription drug Zyprexa. The settlement is the largest ever multistate consumer protection-based pharmaceutical settlement. The second largest was a $58 million agreement reached in May with Merck & Co., Inc. regarding its product Vioxx.
This landmark settlement sends the message that pharmaceutical companies will be held responsible for their actions, including any inappropriate marketing practices which may promote off-label uses that have not been approved, said Attorney General Bill McCollum.
In a complaint simultaneously filed with and resolved by the settlement, Attorney General McCollum and the other state Attorneys General alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed the prescription for off-label uses. The company also allegedly failed to adequately disclose the medications potential side effects to health care providers. Following a lengthy investigation, Eli Lilly agreed to modify its marketing practices for Zyprexa and cease promoting any off-label uses not approved by the U.S. Food and Drug Administration (FDA).
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. While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for such uses. As an atypical antipsychotic, Zyprexa has been associated with an especially high risk of weight gain, hyperglycemia and diabetes.
This agreement is a step in the right direction towards ensuring children are not inappropriately targets for off-label prescription uses and physicians are adequately appraised of a drug’s potential side effects, said Dr. Jerry Isaac, president of the Florida Chapter of the Academy of Pediatrics.
Floridas share of the $62 million is $3.6 million and will be used to fund future enforcement efforts and to reimburse the Attorney Generals Office for its fees and costs. In addition to the monetary provisions, Eli Lilly must adhere to certain behaviors for a period of time extending six years beyond the patent term for Zyprexa. These will include the following
The company must not make any false, misleading or deceptive claims regarding Zyprexa or promote Zyprexa using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
– The company may only provide product samples of Zyprexa to a health
care provider whose clinical practice is consistent with the products current labeling;
– The company 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;
– The company must provide specific, accurate, objective and
scientifically balanced responses to unsolicited requests for off-label information from a health care provider regarding Zyprexa;
– The company must disclose information about grants, including
continuing medical education, on its website for at least two years and must maintain the information for five years;
– The company may not use grants to promote Zyprexa and may not make
continuing medical education funding conditional on Eli Lillys approval of speakers or program content;
– The company must require continuing medical education providers to
disclose Eli Lillys financial support of their programs and any financial relationship with faculty and speakers;
– The company must provide each participating 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; and
– The company must register clinical trials and submit results as
required by federal law, register specific types of Eli-Lilly sponsored Zyprexa clinical trials beginning after July 1, 2005, and post on a publicly accessible website specific types of Eli-Lilly sponsored Phase II, III and IV clinical trials completed after July 1, 2004.
Florida was part of the executive committee which led the investigation into Eli Lillys marketing and promotional practices. Other states on the committee were Arizona, California, Illinois, Ohio, Oregon, Texas, and Vermont. Additional states included in the settlement are Alabama, Delaware, Hawaii, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Washington, and Wisconsin, as well as the District of Columbia.