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星期四, 12月 08, 2016

BRISTOL-MYERS SQUIBB TO PAY $19.5 MILLION FOR ALLEGED IMPROPER DRUG MARKETING TO ENCOURAGE PRESCRIPTIONS TO CHILDREN, ELDERLY

BRISTOL-MYERS SQUIBB TO PAY $19.5 MILLION FOR ALLEGED IMPROPER DRUG MARKETING TO ENCOURAGE PRESCRIPTIONS TO CHILDREN, ELDERLYAG Healey Joins Multistate Settlement; Massachusetts to Receive More Than $400,000
BOSTON – Resolving allegations that it improperly marketed an antipsychotic drug to children and elderly patients, Bristol-Myers Squibb Company (BMS) has agreed to pay a total of $19.5 million in a multistate settlement, including more than $400,000 to Massachusetts, Attorney General Maura Healey announced today. 
In a complaint filed today in Suffolk Superior Court along with a consent judgment, AG Healey alleges that BMS engaged in unfair and deceptive trade practices when it marketed an atypical antipsychotic drug known as Abilify.
“We allege that Bristol-Myers Squibb improperly marketed this drug to encourage prescriptions to children and seniors and misled the public about its safety for those populations,” said AG Healey. “Companies cannot use deceptive practices and unfair marketing to increase their sales at the expense of patients’ health and well-being.”
The investigation, conducted by AG Healey and 42 other state attorneys general, concluded that BMS’s promotional efforts for Abilify contained misrepresentations and material omissions. 
Abilify – the brand name for the prescription drug aripiprazole – was originally approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in 2002 and, since then, has been approved for several additional indications. The complaint alleges that, starting in 2002, BMS promoted Abilify to treat certain other conditions prior to receiving FDA approval for those uses.
In particular, BMS 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. In 2006, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. 
Additionally, the complaint alleges that BMS promoted Abilify for uses in children not approved by the FDA, minimized and misrepresented Abilify’s risks, and overstated the findings of scientific studies by not revealing limitations that would materially affect the interpretation of the study results.
Along with a payment to the states involved, BMS’s marketing of any formulation containing the active ingredient aripiprazole will be restricted by the terms of the settlement. The company will be prohibited from making false or misleading claims about Abilify, its safety or efficacy in comparison with other drugs, or the implications of clinical studies relating to the drug. BMS 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.
The states also joining the BMS settlement include: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, 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. 
This matter was handled in Massachusetts by Assistant Attorney General Stephen Vogel and Deputy Division Chief Eric Gold, both of AG Healey’s Health Care Division.
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