Ortho-McNeill Pleads Guilty to Illegal Promotion of Topamax – $6.14M Fine And $75.37M For Payment of Civil Allegations

The fine appears small compared to also having to pay $75.37 million to resolve civil allegations related to the false medical claims that were generated due to off label illegally promoted use.

The ‘Doctor For A Day Program” is listed as an area where the promotions occurred as well as sales efforts. No more physicians accompanying pharma sales representatives you can almost bet. The drug Topamax was approved by the FDA for epilepsy and not for psychiatric conditions. Again, doctors can use off label prescribing but it cannot be promoted by a company for conditions other than what the FDA has approved. BD

Press Release:

Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million

BOSTON—Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today’s hearing.

U.S. Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Civil Division of the Department of Justice announced today that Ortho-McNeil was sentenced by U.S. Magistrate-Judge Robert B. Collings to pay a criminal fine of $6.14 million.

At the plea hearing, the prosecutor told the court that had the case proceeded to trial, the government’s evidence would have proven that Ortho-McNeil used a promotional program called the “Doctor for a Day Program” as a tool to promote its epilepsy drug, Topamax, for uses which had never been approved by the U.S. Food & Drug Administration (FDA). Through the “Doctor for a Day Program,” Ortho-McNeil paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists. On these sales calls, through the Doctor for a Day, Ortho-McNeil promoted Topamax to psychiatrists, including some in Massachusetts, for psychiatric uses. However, Ortho-McNeil had never applied to the FDA for any approval for Topamax to treat any psychiatric disorders and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.

“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 U.S. Attorney Carmen M. Ortiz. “We will remain vigilant in our enforcement of these laws regardless of what form the conduct takes,” Ortiz concluded.

An affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals Inc. will also pay $75.37 million to resolve civil allegations under the False Claims Act that it illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. Also as part of the settlement, Ortho-McNeil-Janssen Pharmaceuticals entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

The criminal case was prosecuted by Assistant U.S. Attorneys Jeremy Sternberg and Susan Winkler of the U.S. Attorney’s Office for the District of Massachusetts and Jill Furman of the Justice Department’s Office of Consumer Litigation. It was investigated by the U.S. Department of Veterans Affairs, Office of Inspector General; Boston Resident Agency, Criminal Investigations Division; the U.S. FDA’s Office of Criminal Investigations, Boston Resident Office; and the FBI’s Boston Field Office.

The civil investigation and settlement was handled by Assistant U.S. Attorney Zachary A. Cunha of the U.S. Attorney’s Office in Massachusetts and Trial Attorney Colin M. Huntley of the Commercial Litigation Branch of the Justice Department’s Civil Division. The Corporate Integrity Agreement was negotiated by the Office of Inspector General for the Department of Health and Human Services. Assistance was provided by the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.