Pharmacia & Upjohn Company, Inc. Pleads Guilty to Fraudulent Marketing of Bextra
|U.S. Attorney’s Office September 15, 2009|
BOSTON, MA—PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer, Inc (“Pfizer”) today pled guilty to 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. admitted to its criminal conduct in the promotion of Bextra and, in the plea agreement, agreed to pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. PHARMACIA & UPJOHN COMPANY, INC. also agreed to forfeit $105 million, for a total criminal resolution of $1,300,000,000. United States District Judge Douglas P. Woodlock took the plea but deferred his decision as to the acceptance of the plea until the date of sentencing. Sentencing has been scheduled for October 16, 2009 at 9:30 a.m.
In addition, as announced on September 2, 2009, Pfizer agreed to pay an additional $1 billion 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 today’s plea hearing, the prosecutor informed the court that if the 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:
1. Headquarter Marketing Plans: PHARMACIA’s marketing team positioned Bextra for acute pain, surgical pain, and other unapproved uses and dosages, commissioned market research to test its sales materials, and confirmed these unapproved messages. In such documents, PHARMACIA marketing team stated as the “intended” use and message for Bextra that Bextra was for “acute pain.”
2. Field Force Implementation: PHARMACIA’s sales force promoted Bextra directly to physicians for these unapproved uses and dosages, including by drafting and distributing proposed physician standing orders and hospital wide protocols and pain pathways that called for unapproved uses of Bextra. The sales force also made false and misleading claims to physicians about Bextra's safety and efficacy.
3. Payments and Other Remuneration to Physicians/Purported Consultants: PHARMACIA used so-called advisory boards, consultant meetings and other remuneration, including travel to lavish resorts, to promote Bextra to medical prescribers for unapproved uses and dosages and with false and misleading claims as to its safety and efficacy.
4. Sham Physician Requests for Off-Label Information: PHARMACIA’s sales force created sham physician requests for medical information in order to send unsolicited information to physicians about unapproved uses and dosages.
5. Distributing Samples for Unapproved Uses and Dosages: PHARMACIA provided promotional samples to surgeons and other medical prescribers who had no FDA-approved use for the Bextra samples, or at that dosage;
6. Control of Purportedly Independent Medical Education ("CME"): PHARMACIA sponsored purportedly independent CME to disseminate messages about unapproved uses of Bextra, including for acute and surgical pain.
7. Use of a Publication Strategy to Disseminate Off-label Messages: PHARMACIA initiated and paid vendors to draft articles about Bextra for unapproved uses without appropriate disclosures of PHARMACIA’s role.
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.
Acting United States Attorney Michael K. Loucks said, “PHARMACIA has pled guilty to marketing Bextra for unapproved uses with the intent to defraud and mislead. The record-breaking criminal resolution here reflects the seriousness and the profitability of PHARMACIA's crime. We can only hope that with this resolution, the era of pharmaceutical companies carrying on illegal marketing activities with impunity with the cost born by the patients and the health care system, has come to an end.”
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.