Company pays over $81m for allegedly promoting topiramate for unapproved uses

BMJ 2010; 340 doi: (Published 27 May 2010) Cite this as: BMJ 2010;340:c2848
  1. Zosia Kmietowicz
  1. 1London

    Two subsidiaries of drug giant Johnson & Johnson have agreed to pay fines of more than $81m (£56m; €65m) for allegedly illegal promotion of the epilepsy drug topiramate (Topamax) for psychiatric uses, the US Justice Department announced on 24 May.

    Ortho-McNeil Pharmaceutical LLC, one of the subsidiaries, pleaded guilty to one count of misdemeanour for promoting topiramate for uses that were not approved by the US Food and Drug Administration (FDA) and was ordered to pay a criminal fine of $6.14m.

    The government says that the company promoted topiramate for unapproved uses under a scheme called “Doctor for a Day,” which it operated between 2001 and 2003. Under the scheme Ortho-McNeill hired doctors to accompany sales representatives during visits to other doctors, including psychiatrists, and to speak at meetings and dinners about prescribing topiramate for psychiatric disorders.

    The government claimed that Ortho-McNeil never applied for approval to use topiramate to treat psychiatric conditions and that there were no reliable clinical trials showing that the drug is safe and effective to treat psychiatric conditions.

    Topiramate is licensed in the US to prevent seizures and migraines. It has been one of the biggest selling drugs for Johnson & Johnson with sales of nearly $3bn in 2008. In April 2009, however, the FDA approved generic versions of topiramate, which led to a fall in revenue for the company.

    US Attorney Carmen M Ortiz said: “This case 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.’ We will remain vigilant in our enforcement of these laws regardless of what form the conduct takes.”

    The government also announced that an affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals Inc. will pay $75.37m to resolve civil allegations that it illegally promoted topiramate and caused false claims to be submitted to government healthcare programmes for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programmes.

    As part of the settlement, the company entered into a five year corporate integrity agreement with the Department of Health and Human Services.

    Ortho-McNeil-Janssen denies it engaged in any wrongful conduct, with the exception of acknowledging the admissions made by Ortho-McNeil Pharmaceutical LLC in connection with the misdemeanor plea.

    Greg Panico, a spokesman for Ortho-McNeil-Janssen Pharmaceuticals, said in a statement, “We take the investigation and settlement very seriously, and we are fully committed to meeting the terms of the agreement.’’

    The settlement resolves two lawsuits brought under the False Claims Act, in which whistleblowers can sue on behalf of the US. More than $9m of the settlement will go to the private citizens who brought the lawsuits.


    Cite this as: BMJ 2010;340:c2848