Originally published September 20 2010
J&J pleads guilty to illegal marketing of psychiatric drugs
by David Gutierrez, staff writer
(NaturalNews) A subsidiary of pharmaceutical giant Johnson & Johnson (J&J) has pleaded guilty in federal court to misdemeanor charges of marketing a drug for unapproved uses.
The guilty plea comes as part of a larger, $81-million settlement signed by J&J to settle government allegations that it illegally marketed its anti-seizure drug Topamax for the treatment of conditions including bipolar disorder and drug and alcohol addiction.
U.S. law allows doctors to prescribe drugs for any use they see fit, but prohibits drug makers from actively promoting drugs for any use not specifically approved by the FDA.
According to prosecutors, J&J sought to get around this restriction through a program it called "Doctor-for-a-Day," in which doctors would accompany sales representatives on marketing visits. These doctors would then promote Topamax for unapproved uses, allowing company employees to keep their hands clean. According to internal documents, sales representatives told doctors that the Doctor-for-a-Day could "talk to you about things I can't talk to you about."
Participating doctors were paid up to $3,000 per day plus expenses, with one neurologist making half a million dollars for 200 appearances.
"This case should send a strong reminder that the off- label promotion of pharmaceuticals is illegal, whether it is done directly by company employees or through programs such as the doctor for a day program," said U.S. Attorney Carmen Ortiz.
Under the terms of the settlement, J&J subsidiary Ortho-McNeil Pharmaceutical LLC will pay a $6.14 million fine and will adopt a corporate integrity agreement designed to prevent repeat offenses. Another subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, will pay $75.37 to settle a civil lawsuit by the federal government for the same complaint.
Until its patent expired in 2009, Topamax was a major income-generator for J&J, capturing 21 percent of the market for epilepsy drugs in the United States. In 2008, Topamax sales totaled $2.7 billion.
Sources for this story include: http://www.businessweek.com/news/2010-05-21/...
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