BOSTON, Oct. 16 /PRNewswire-USNewswire/ -- PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. ("Pfizer") today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead. PHARMACIA & UPJOHN COMPANY, INC. was sentenced by United States District Judge Douglas P. Woodlock to pay a criminal fine of $1.195 billion and a criminal forfeiture of $105 million, for a total criminal resolution of $1,300,000,000. This is the largest criminal fine ever imposed in the United States for any matter.
In addition, as announced on September 2, 2009, Pfizer agreed to pay an additional one billion dollars plus interest to settle civil allegations that it fraudulently promoted and marketed Bextra, as well as three other drugs in its portfolio, Geodon, an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, an anti-epileptic drug, as well as claims that it paid kickbacks for these, as well as other drugs, to induce physician prescribing. Pfizer also agreed to comply with the terms of a new and significantly expanded corporate compliance program, which seeks to ensure that in the future there are procedures and reviews in place to avoid, or, at a minimum, timely detect such violations.
At an earlier plea hearing, the prosecutor informed the court that had this case had gone to trial, the government's evidence would have proven that:
When Bextra received its approval from the U.S. Food and Drug Administration ("FDA") in November 2001, the FDA notified PHARMACIA & UPJOHN COMPANY, INC. that Bextra was approved for three indications: osteoarthritis ("OA"), adult rheumatoid arthritis ("RA") and for the treatment of primary dysmennorrhea ("PD"). PHARMACIA & UPJOHN COMPANY, INC. had originally sought approval of Bextra for higher dosages for general acute pain, including surgical pain. However, the FDA declined to app
|SOURCE U.S. Department of Justice|
Copyright©2009 PR Newswire.
All rights reserved