Healthy Skepticism Library item: 17864

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kmietowicz Z
Company pays over $81m for allegedly promoting topiramate for unapproved uses
BMJ 2010 May 27; 340:
http://www.bmj.com/cgi/content/extract/340/may27_2/c2848

Abstract:

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 . . .