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 approve Bextra for these uses and for any dosage for arthritis above 10 mg., in part, because of safety concerns about Bextra. In particular, the FDA cited as a safety concern the results of a study of Bextra and its injectable form, parecoxib, used in patients undergoing coronary artery bypass graft surgery (the "CABG I" trial); the FDA specifically noted that there was an excess of serious cardiovascular events in the Bextra/parecoxib arm of the trial.
Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses - any use not specified in an application and approved by FDA.
Nonetheless, from in or about February 2002 through Bextra's removal from the market in April 2005, PHARMACIA & UPJOHN COMPANY, INC., first through a co-promotion agreement with Pfizer, and then as a subsidiary of and with Pfizer (hereinafter together "PHARMACIA"), promoted the sale of Bextra for some of the very uses and dosages that the FDA had declined to approve - such as for general acute pain and surgical pain - and about which the FDA had raised specific safety concerns. It also promoted Bextra with false and misleading claims of safety and efficacy. Moreover, when so promoting Bextra, PHARMACIA did not inform physicians, customers and others that it had asked the FDA to approve Bextra for these uses, but that the FDA had specifically refused to do so in part because of safety issues, including potential cardiovascular risks. PHARMACIA did this in the following ways:
As part of the Plea Agreement, PHARMACIA accepted responsibility for its illegal conduct and the United States agreed that PHARMACIA had fully cooperated in the investigation.
This case was handled by Assistant U.S. Attorneys Sara Miron Bloom, Susan M. Poswistilo and Zachary Cunha of the U.S. Attorney's Office for the District of Massachusetts, Sanjay Bhambhani of the Department of Justice's Civil Fraud section, Trial Attorney Jill Furman of the Justice Department Office of Consumer Litigation and Anne Walsh of the FDA General Counsel's Office. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services, Federal Bureau of Investigation, Defense Criminal Investigative Service, the Office of Criminal Investigations for the Food and Drug Administration, the Veteran's Administration's Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management and the Office of the Inspector General for the United States Postal Service.
SOURCE U.S. Department of Justice
|SOURCE U.S. Department of Justice|
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