Navigation Links
Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resolves Investigation of Past TOPAMAX(R) Marketing and Promotional Activities

TITUSVILLE, N.J., April 29 /PRNewswire/ -- 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

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, 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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Agrees to $75 Million Settlement for Topamax(R) False Claims Lawsuit
2. AUDIO from Medialink and Ortho-McNeil-Janssen Pharmaceuticals Inc.: Getting Ready for Cold and Flu Season
3. Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Type 2 Diabetes Drug Candidate in Partnership with Ortho-McNeil-Janssen Pharmaceuticals
4. ADVENTRX Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2009 Financial Results
5. Ampio Pharmaceuticals, Inc. Retains Redwood Consultants, LLC to Assist in Shareholder Relations and Strategic Planning
6. Chay Enterprises Inc. Completes Merger With Repurposed Drug Developer Ampio Pharmaceuticals, Inc.
7. Jazz Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2009 Financial Results
8. GlaxoSmithKline President of North America Pharmaceuticals, Deirdre Connelly, Named 2010 Woman of the Year by the Healthcare Businesswomens Association
9. Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
10. China Yongxin Pharmaceuticals, Inc. Announces Results for the Third Quarter Ended September 30, 2009
11. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data, Including New Survival Data, on KRX-0401 (Perifosine) in the Treatment of Advanced Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
Post Your Comments:
(Date:10/11/2017)... 11, 2017  BioPharmX Corporation (NYSE MKT: BPMX) researchers ... an innovative way to use nonlinear optical imaging to ... new drugs. ... will show how researchers from BioPharmX and the Wellman ... used a suite of imaging techniques in what is ...
(Date:10/11/2017)... , Oct. 11, 2017  True Health, ... has amplified its effort during National Breast Cancer ... hereditary cancer risks. ... Clinical Oncology calculated that more than 10 million ... inherited mutations in BRCA1 or BRCA2 and have not ...
(Date:10/10/2017)... received FDA 510(k) clearance in May 2017 for its highly anticipated ... for endoscopy environments. An innovative secondary monitor solution, ZeroWire Mobile ... the improvement of patient outcomes, procedural efficiency, and the lowering of ... ... By ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and ... explains one of the most popular and least understood books in the Holy Scriptures, ... puzzling descriptions that have baffled scholars for centuries. Many have tossed it off as ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... Wis. (PRWEB) , ... October 12, 2017 , ... ... standard products to meet the demand of today’s consumer and regulatory authorities worldwide. ... of probiotic experts and tested to meet the highest standard. , These ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about ... intend to develop to enable prevention of a major side effect of chemotherapy ... especially in pediatric patients. For cisplatin, hearing loss is FDA listed on-label as ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, the ... – Miles by Moonlight to raise money for the American Heart Association Heart Walk. ... , Teams will work together to keep their treadmills moving for 5 hours. Treadmills ...
Breaking Medicine News(10 mins):