Otsuka to Pay Fine to Resolve Abilify Marketing Probe

Bloomberg News

By Robert Schmidt and Beth Jinks

Otsuka Pharmaceutical Co. agreed to pay $4 million to resolve U.S. allegations it marketed the schizophrenia drug Abilify for off-label uses in cahoots with Bristol-Myers Squibb Co., which settled in September.

The Justice Department accused New York-based Bristol-Myers and Otsuka American Pharmaceutical Inc., a U.S. subsidiary of the closely held Japanese drugmaker which invented Abilify, of promoting the antipsychotic for use in children, and as a remedy for dementia, without regulator approval.

Use in children wasn’t approved by the U.S. Food and Drug Administration at the time, and the drug is required to carry the most severe safety warning, a so-called black box, for use in dementia-related psychosis.

In September, Bristol-Myers completed an agreement to pay $515 million to settle U.S. allegations it overcharged the government for drugs and promoted medicines including Abilify for unapproved uses. Bristol-Myers directed its sales force to visit child psychiatrists and nursing homes, the Justice Department said in September. Otsuka’s sales force was “led primarily by Bristol-Myers sales managers,” the department said today.

Otsuka will pay the U.S. government about $2.3 million and the remainder to states’ Medicaid programs, the company said in a statement. It agreed to a corporate integrity agreement, without specifying the length of the compliance and monitoring pledged…

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1 Comment

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One response to “Otsuka to Pay Fine to Resolve Abilify Marketing Probe

  1. This is fantastic news!!! Yea for children everywhere, who were given these drugs that were designed for adults.
    But understand this: There is more money spent on ads than on research and development, and it is not the scientist that has the best product, it is the one who puts on the best show, who wins approval from the FDA.
    When we fully get the message out there to feed our kids great nutrition, teach them how to problem solve,pertaining to emotions, and give them wings to fly, instead of parking them infront of a TV , and of having no boundries, of not having a voice unless it is disfunctional, then we will have healthy well balanced kids, or the beginnings anyway.
    Home should be a haven, no darkness[as relates to depression] there. School should be an exchange, not who has or has not. How you stand in your community should not be dictated by your zip code. Kids need to understand value of humanity, and humility, instead, of me, me, me. Each of us has a job to do, while we are here. Addicting kids to mind altering drugs, because it pays the drug companies, the school system or the parents, is wrong.And so it is super to see the cartel[drug companies fall] It is a new beginning….. It is time, if we are to save our kids. We older folk, who bought the bill of sales[disfunction] that wasn’t in most cases fact, are the best sources to lead the charge… In this way we mentor.. you are not your dis-ease, in any way. we each are spirit.
    Peace

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