Two New Jersey drugmakers owned by Johnson & Johnson are pleading guilty to inappropriately marketing an epilepsy drug for off-label uses and will pay $81 million in criminal and civil fines related to its conduct.
J&J subsidiaries to pay $81 million in Topamax case
Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals, which are based in Titusville, N.J., are both subsidiaries of Johnson & Johnson. They were charged by federal regulators with using a program known as “Doctor-for-a-Day” in which physicians were hired to accompany sales teams and speak at meetings and dinners about off-label uses of the drug Topamax.
Topamax was approved by the Food and Drug Administration as an anti-epileptic and migraine-prevention drug, but not for psychiatric use, the government said.
Johnson & Johnson said in a news release that the company denied any wrongdoing beyond the one misdemeanor charge to which it was pleading guilty. The company has discontinued the marketing program and has previously reserved the $81.5 million to pay the penalty.
The company will pay $6.1 million in criminal fines, and $75.4 million to resolve the civil allegations, and will submit to a five-year corporate integrity agreement, including compliance monitoring by the HHS' inspector general's office. About $9 million of the settlement will go to the corporate whistle-blowers who first made the allegations against the company.
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