Two subsidiaries of Johnson & Johnson will pay over $81m in criminal and civil liability costs accrued from the illegal promotion of the epilepsy drug Topamax.
Topamax, an anti-epileptic drug, was being promoted for use other than that approved by the US FDA for partial onset seizure.
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The US Justice Department alleged the company promoted the product for off-label psychiatric use through the Doctor-for-a-Day programme, which partnered outside physicians with sales representatives on visits to medical offices to promote the product.
The US Justice Department said Ortho-McNeil Pharmaceutical has been fined $6.14m for midbranding Topamax in violation of the Food, Drug and Cosmetic Act.
Ortho-McNeil-Janssen Pharmaceuticals said it will pay $75.37m to resolve civil allegations under the False Claims Act.
It is alleged the company illegally promoted Topamax in government healthcare programmes.
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By GlobalDataAssistant Attorney General for the Civil Division of the Department of Justice Tony West said the government is committed to enforcing regulations around the off-label promotion of drugs.
“This type of unlawful marketing undermines the FDA’s important role in deciding which drugs are safe and effective for consumers and costs the taxpayers billions of dollars each year,” West said.
