Navigation Links
FDA Announces Results of Investigation Into Illegal Promotion of,OxyContin by The Purdue Frederick Company, Inc.

Company Misrepresented Prescription Pain Reliever to Health Care Professionals

ROCKVILLE, Md., May 10, 2007-The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.

An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and by representing that "…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug."

“FDA will not tolerate practices that falsely promote drug products and place consumers at health risk,” said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. “We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars.”

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States.

In addition, Purdue's current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications.

This case was prosecuted by the U. S. Attorney’s Office for the Western District of Virginia and investigated by FDA's Office of Criminal Investigations; the Internal Revenue Service’s Criminal Investigations Division; the U.S. Department of Health and Human Services’ Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation.


'"/>




Related medicine technology :

1. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
2. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
3. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
4. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
5. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
8. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
9. Protox Announces Positive Clinical Data from Prostate Cancer Study
10. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)...  Sangamo BioSciences, Inc. (NASDAQ: SGMO ), ... its fourth quarter and full year 2015 financial ... therapeutic genome editing," said Edward Lanphier, Sangamo,s president ... (ZFN) technology leads the therapeutic genome editing field ... to move our ground-breaking genome editing programs through ...
(Date:2/9/2016)... Mast Therapeutics, Inc. (NYSE MKT: MSTX), ... disease and heart failure, today announced that it intends to ... stock in an underwritten public offering.  The offering is subject ... assurance as to whether or when the offering may be ... the offering.   --> --> ...
(Date:2/9/2016)... The global prefilled syringes market accounted for $3,905.1 million ... with a CAGR of 12.9% during 2015-2020. Among the ... global prefilled syringes market, with 90.1% share in 2014. ... global market of prefilled syringes is up surging with ... demand for vaccines, increasing prevalence of chronic and lifestyle ...
Breaking Medicine Technology:
(Date:2/10/2016)... IN (PRWEB) , ... February 10, 2016 , ... ... benefits advisory organization, welcomes S.S. Nesbitt as the latest addition to its growing ... has seven other locations throughout the Southeast, from Orlando to Huntsville and in ...
(Date:2/10/2016)... ... February 10, 2016 , ... Pediatric therapists are challenged ... Research shows that the Goal Attainment Scale (GAS) captures 20% more change in ... learn more about the Goal Attainment Scale, Education Resources Inc. is offering a ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... and accessories. These PEEK-lined stainless steel (PLS) columns combine the strength of traditional ... ensures the integrity of biological samples while operating at ultra-high pressures of 20,000 ...
(Date:2/10/2016)... ... February 10, 2016 , ... Anxiety of older Americans over steep cost ... Part D a decade ago, according to The Senior Citizens League (TSCL). ... they are coping with rapidly rising costs. “The implications are chilling, particularly for ...
(Date:2/10/2016)... ... February 09, 2016 , ... Traumatic Brian Injury is ... may be one of many possible sources: sports, car accidents, falls, work accidents, ... Mastering Rehab Solutions for the Complexities of Concussions is designed for ...
Breaking Medicine News(10 mins):