TITUSVILLE, N.J., April 29 Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) today announced an agreement with the U.S. Attorney's Office for the District of Massachusetts, the U.S. Department of Justice, and other federal agencies to resolve a previously reported government investigation of past U.S. marketing and promotional practices for TOPAMAX® (topiramate), an antiepileptic and migraine prevention prescription medicine.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. has been cooperating with the government since its investigation began in December 2003. OMJPI has entered into a settlement agreement resolving the federal government's investigation. The settlement includes total payments of $81.5 million plus interest, an amount previously reserved for, to the federal government and state Medicaid programs.
As one part of the resolution, Ortho-McNeil Pharmaceutical, L.L.C., 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 $6.1 million criminal fine. OMJPI denies it engaged in any wrongful conduct, with the exception of acknowledging the admissions made by Ortho-McNeil Pharmaceutical, L.L.C. in connection with the misdemeanor plea. The guilty plea is subject to approval by the U.S. District Court for the District of Massachusetts. The balance of the total settlement amount, $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 programs.
The plea states that the subsidiary, Ortho-McNeil Pharmaceutical, L.L.C., through one of its promotional programs, in some instances between 2001 and 2003, promoted TOPAMAX for certain uses not approved by the U.S. Food and Drug Administration. Ortho-McNeil Pharmaceutical, L.L.C. voluntarily discontinued the program at issue before receiving the government's first subpoena in the investigation.
OMJPI has a robust compliance program, 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 U.S. Department of Health and Human Services (HHS).
The CIA is largely consistent with the Company's existing compliance program, and reflects OMJPI's commitment to ensuring integrity in the delivery of essential medicines to patients. OMJPI's existing compliance program 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.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is headquartered in Titusville, New Jersey. For more information, visit www.omjpi.com.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Ortho-McNeil-Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ortho-McNeil-Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.