Navigation Links
Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resolves Investigation of Past TOPAMAX(R) Marketing and Promotional Activities
Date:4/29/2010

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 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.
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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... payment industry today announced its strategic partnership with Connance, a healthcare industry ... The two companies’ proven, proprietary technology combine to provide health systems, hospitals ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
Breaking Medicine News(10 mins):