pleads guilty to illegal marketing of psychiatric drugs
A subsidiary of
pharmaceutical giant Johnson & Johnson (J&J) has pleaded guilty
in federal court to misdemeanor charges of marketing a drug for unapproved
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."
doctors were paid up to $3,000 per day plus expenses, with one neurologist
making half a million dollars for 200 appearances.
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
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.
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