Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson, pled guilty Monday in federal court to illegally promoting its epilepsy drug Topamax for off-label psychiatric uses. The case stems from a promotional campaign called the “Doctor for a Day Program,” in which the company paid outside physicians to sit in with company reps on sales calls about Topamax to other physicians. The company had never applied to the Food and Drug Administration for approval of Topamax to treat psychiatric disorders.
The guilty plea came with a $6.14 million fine for Ortho-McNeil. An affiliate of the company, Ortho-McNeil-Janssen Pharmaceuticals,will pay $75.37 million to resolve civil allegations that it violated the False Claims Act by illegally promoting Topamax and causing false claims for its use to be submitted to government healthcare programs. From the FDA press release:
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,’” said United States Attorney Carmen M. Ortiz. “We will remain vigilant in our enforcement of these laws regardless of what form the conduct takes,” Ortiz concluded.
Company representatives called the ruling fair. A company spokesman for Ortho-McNeil-Janssen told Bloomberg news that “the company has taken appropriate action with this settlement agreement and is fully committed to meeting its requirements.”


