Drug Makers to Pay Fine of $81 Million - Illegal marketing of antipsychotic drug
source: http://www.nytimes.com/2010/04/30/business/30fine.html?src=busln
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- PepsiJuror
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By THE ASSOCIATED PRESS
Published: April 29, 2010
WASHINGTON (AP) — The Justice Department announced Thursday that two subsidiaries of the pharmaceutical giant Johnson & Johnson had agreed to pay more than $81 million in a case accusing them of illegally promoting the epilepsy drug Topamax for psychiatric uses.
Federal drug regulators approved Topamax for epilepsy and for preventing migraine headaches.
It was the second settlement this week involving a pharmaceutical manufacturer accused of misconduct involving promotion of unapproved uses for a drug.
On Tuesday, Attorney General Eric H. Holder Jr. and Kathleen Sebelius, the secretary of health and human services, announced a $520 million settlement with AstraZeneca, resolving allegations of illegal marketing of the company’s antipsychotic drug Seroquel.
In the case involving Topamax, the government says Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals unit will pay more than $75 million. That unit’s subsidiary, Ortho-McNeil Pharmaceutical, has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act and to pay a $6.1 million criminal fine.
The government says that Ortho-McNeil Pharmaceutical promoted Topamax sales for unapproved psychiatric uses under a program called Doctor-for-a-Day. The program hired outside physicians who joined sales representatives in visits to health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses.
Topamax had been a blockbuster for Johnson & Johnson, with sales topping $2 billion a year by 2006 and peaking at $2.7 billion in 2008. Topamax was approved for preventing migraine headaches about five years ago. The drug got generic competition in March 2009, and sales for the year plunged to $148 million.
Ortho-McNeil-Janssen said it had cooperated with the government since its inquiry began in 2003.
The settlement resolves two lawsuits brought under the False Claims Act. More than $9 million of it will go to the private citizens who brought the suits.
http://www.nytimes.com/2010/04/30/business/30fine.html?src=busln
http://www.edrugsearch.com/edsblog/wp-content/uploads/2008/07/fdaapproved.jpg
Published: April 29, 2010
WASHINGTON (AP) — The Justice Department announced Thursday that two subsidiaries of the pharmaceutical giant Johnson & Johnson had agreed to pay more than $81 million in a case accusing them of illegally promoting the epilepsy drug Topamax for psychiatric uses.
Federal drug regulators approved Topamax for epilepsy and for preventing migraine headaches.
It was the second settlement this week involving a pharmaceutical manufacturer accused of misconduct involving promotion of unapproved uses for a drug.
On Tuesday, Attorney General Eric H. Holder Jr. and Kathleen Sebelius, the secretary of health and human services, announced a $520 million settlement with AstraZeneca, resolving allegations of illegal marketing of the company’s antipsychotic drug Seroquel.
In the case involving Topamax, the government says Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals unit will pay more than $75 million. That unit’s subsidiary, Ortho-McNeil Pharmaceutical, has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act and to pay a $6.1 million criminal fine.
The government says that Ortho-McNeil Pharmaceutical promoted Topamax sales for unapproved psychiatric uses under a program called Doctor-for-a-Day. The program hired outside physicians who joined sales representatives in visits to health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses.
Topamax had been a blockbuster for Johnson & Johnson, with sales topping $2 billion a year by 2006 and peaking at $2.7 billion in 2008. Topamax was approved for preventing migraine headaches about five years ago. The drug got generic competition in March 2009, and sales for the year plunged to $148 million.
Ortho-McNeil-Janssen said it had cooperated with the government since its inquiry began in 2003.
The settlement resolves two lawsuits brought under the False Claims Act. More than $9 million of it will go to the private citizens who brought the suits.
http://www.nytimes.com/2010/04/30/business/30fine.html?src=busln
http://www.edrugsearch.com/edsblog/wp-content/uploads/2008/07/fdaapproved.jpg
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bailey78
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I would like to see a large portion of these types of drugs taken off the market all together. Most just make Zomies out of us. I guess a druged person is easyer to brainwash than a sober one.
- 2 years ago
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bailey78
