Connecticut Joins Multistate Settlement with
Bristol-Myers Squibb over Abilify Marketing Allegations
Connecticut has joined a $19.5 million multistate settlement with drug-maker Bristol-Myers Squibb to resolve allegations that the company improperly marketed the atypical antipsychotic drug, Abilify, Attorney General George Jepsen and state Department of Consumer Protection (DCP) Commissioner Jonathan A. Harris announced today.
Abilify is the brand name for the prescription drug aripiprazole, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2002 for the treatment of schizophrenia in adults; the FDA has since approved Abilify in various formulations for several indications, including the treatment of bipolar disorder in certain children and adults, treatment of major depressive disorder in adults, and the treatment of schizophrenia in certain children, among others.
The states allege, however, that Bristol-Myers Squibb promoted Ability for use in elderly patients with symptoms consistent with dementia and Alzheimer's disease despite lack of FDA approval for this use and without establishing the drug's safety. In 2006, the FDA issued a black-box warning for Abilify stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
The states also allege that Bristol-Myers Squibb marketed Abilify for children suffering from schizophrenia before it was approved by the FDA for children, and that the company minimized and misrepresented the risks associated with taking Abilify.
"Companies are prohibited under state law from making false or deceptive claims about the products they produce and sell," said Attorney General Jepsen. "In the case of drug companies, the products they create and sell, and the representations they make about those products, have a direct impact on the health and well-being of patients, which makes it all the more important that those representations be truthful. Allegations of false representations about a drug's safety or effectiveness will not go unaddressed."
"Products sold by pharmaceutical companies have a direct impact on public health and safety, and when deceptive claims are made regarding their products, it hurts patients, families and trust in the healthcare system," said Commissioner Harris. "Consumers deserve to do business with companies that make honest representations of their products as those products have a direct impact on their health and well-being. We're dedicated to continuing to make sure it's clear to companies that these unfair practices will not be tolerated."
Connecticut's share of the settlement funds is $310,133. Of those settlement funds, $15,000 will be deposited in DCP's Consumer Protection Fund and $15,000 will be deposited in the Attorney General's Consumer Protection Fund; both funds are used by the respective agency to support investigations, training and consumer outreach efforts. The remaining settlement funds will be deposited in the state's General Fund.
In addition to the monetary payment, Bristol-Myers Squibb faces several restrictions on its marketing of Abilify through the settlement, and the company is prohibited from making false or misleading claims about Abilify, about its safety or efficacy in comparison to other drugs and about the implications of clinical studies related to Abilify. The company will be subject to limitations on financial incentives to sales representative and healthcare providers, dissemination of information to may promote Abilify's off-label use and other practices involving off-label promotion.
In addition to Connecticut, and led by the states of Maryland and Kentucky, other state's participating in this settlement include Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, 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, and the District of Columbia.
Assistant Attorneys General Jeremy Pearlman and Lorrie Adeyemi, head of the Consumer Protection Department, assisted the Attorney General with this matter.
Office of the Attorney General:
Jaclyn M. Falkowski
Department of Consumer Protection:
Lora Rae Anderson
Facebook: Attorney General George Jepsen