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Creators Of The Drug “Ability†To Pay $19.5 Million penalty For Alleged Improper Marketing INDIANAPOLIS, Ind. – Attorney General Greg Zoeller announced today Indiana joined 41 other states and the District of Columbia in a multi-state, $19.5 million settlement with drug manufacturer Bristol-Myers Squibb Company due to the alleged improper marketing of Abilify, an atypical antipsychotic medication. The state of Indiana will receive $399,594, dedicated toward consumer protection and education. In a complaint filed today in court along with a settlement agreement, the participating states allege that Bristol-Myers Squibb engaged in unfair or deceptive trade practices when it marketed Abilify, the brand name for the prescription drug aripiprazole. “It is imperative that pharmaceutical companies conduct their marketing operations with full transparency, not only informing consumers of the health benefits, but also the risks associated with their product,†Zoeller said. “I commend all who worked diligently in their efforts to ensure an outcome that represents a zero-tolerance attitude toward misleading and misguiding information.†The states allege that Bristol-Myers Squibb promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease despite the lack of FDA approval for these uses and without first establishing the drug’s safety and efficacy for those uses. Additionally, the complaint alleges that Bristol-Myers Squibb promoted Abilify for uses in children not approved by the FDA, and also minimized and misrepresented risks by making false and misleading representations about Abilify. The complaint further alleges that Bristol-Myers Squibb overstated the findings of scientific studies by not revealing limitations that would materially affect the interpretation of the study results. In the terms of the settlement, Bristol-Myers Squibb’s marketing of any formulation containing the active ingredient aripiprazole will be restricted. Bristol-Myers Squibb will be prohibited from making false or misleading claims about Abilify, about its safety or efficacy in comparison with other drugs, and about the implications of clinical studies relating to the drug. The pharmaceutical company will also be subject to limitations on financial incentives to sales representatives and health care providers, dissemination of information that may promote off-label use of Abilify, and other practices affecting off-label promotion. Indiana was joined in the settlement by Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin. |
