Ortho-McNeil-Janssen Pharmaceuticals, Inc (OMJPI) has entered into an agreement with the US Attorney's Office for the District of Massachusetts, the US Department of Justice and other federal agencies to resolve a previously reported government investigation of past US marketing and promotional practices for Topamax (topiramate), an antiepileptic and migraine prevention prescription medicine.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. has been co-operating with the government since its investigation began in December 2003. OMJPI settlement agreement includes total payments of US$ 81.5 million plus interest, an amount previously reserved for, to the federal government and state medicaid programmes.
As one part of the resolution, Ortho-McNeil Pharmaceutical, LLC, a subsidiary of OMJPI, has agreed to plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act and to pay a US$ 6.1 million criminal fine.
OMJPI has denied that it has engaged in any wrongful conduct, with the exception of acknowledging the admissions made by Ortho-McNeil Pharmaceutical, LLC in connection with the misdemeanor plea. The guilty plea is subject to approval by the US District Court for the District of Massachusetts. The balance of the total settlement amount, US$ 75.4 million, is a civil payment, part of which will be paid to the federal government and part of which will be made available to states for their medicaid programmes.
The plea states that the subsidiary, Ortho-McNeil Pharmaceutical, LLC, through one of its promotional programs, in some instances between 2001 and 2003, promoted Topamax for certain uses not approved by the US Food and Drug Administration. Ortho-McNeil Pharmaceutical, LLC voluntarily discontinued the programme at issue before receiving the government's first subpoena in the investigation.
OMJPI has a robust compliance programme, which it will continue as part of this settlement through a five-year corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the US Department of Health and Human Services (HHS).
The CIA is largely consistent with the company's existing compliance programme, and reflects OMJPI's commitment to ensuring integrity in the delivery of essential medicines to patients. OMJPI's existing compliance programme includes: a chief compliance officer; corporate compliance committee; code of conduct; extensive compliance training, policies and procedures regarding the appropriate promotion of OMJPI products; auditing, monitoring, and reporting, including a compliance hotline; and processes for disciplinary and corrective action.