Friday, March 28, 2008

U.S. Justice Dept. Pops Antipsychotic Drug Maker - Promoting Use for Children

Abilify, Geodon, Risperdal, Seroquel and Zyprexa  are the names of the "atypical antipsychotics".  They are newer, more expensive and just as damaging as the older "antipsychotics" such as Thorazine and Haldol.
It is illegal for a drug company to promote a drug for uses not approved by the FDA.    Example.  Promoting Antipsychotic Drugs for "ADHD" .
Otsuka to Pay Fine to Resolve Abilify Marketing Probe
Bloomberg News

By Robert Schmidt and Beth Jinks
March 27, 2008

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.

Abilify Booth at NAMI CONVENTION (National Alliance on Mental Illness), San Diego, CA June 20 - June 24, 2007 (courtesy of

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.

Bristol-Myers also agreed to a five-year corporate integrity agreement that requires the company to maintain compliance programs to monitor business practices. It avoided criminal charges.

The U.S. investigation of Bristol-Myers involved more than 50 medicines. The company was accused of inflating prices used by the government to set reimbursement rates for some drugs, and improper promotional activities for others.   

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