J&J to Pay $81 Million to Federal Government over Topamax Promotion

Washington, DCJohnson & Johnson has agreed to pay $81 million to the US Justice Department as settlement over allegations that the pharmaceutical company illegally promoted the epilepsy drug Topamax for unapproved uses, specifically for psychiatric indications.

Topamax is approved by the FDA for use in epilepsy patients and migraine prevention.

The New York Times reports that Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, will pay more than $75 million, and Ortho-McNeil Pharmaceutical will plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act and pay a $6.1 million criminal fine.

According to the Justice Department, Ortho-McNeil Pharmaceutical used a program called Doctor-for-a-Day to promote sales of Topamax for psychiatric indications. Sales for the drug reached $2 billion annually by 2006, and peaked in 2008 at $2.7 billion. A generic version of the drug came online in 2009, and Johnson & Johnson's sales subsequently plunged to $148 million.