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

[Guest guest]

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 " .

http://tmap.wordpress.com/2008/03/27/otsuka-to-pay-fine-to-resolve-abili

fy-marketing-probe/

Otsuka to Pay Fine to Resolve Abilify Marketing Probe

Bloomberg News

By 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.

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.

+++

Abilify Booth at NAMI CONVENTION (National Alliance on Mental Illness),

San Diego, CA June 20 - June 24, 2007 (courtesy of www.namipharma.org)

+++