Pfizer Inc. “Fraudulent Marketing”: “Largest Health Care Fraud Settlement in Its History” (2009). US Department of Justice

Pfizer to Pay $2.3 Billion for Fraudulent Marketing

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Introductory Note

This text originally published by the US Department of Justice in September 2009 is of utmost relevance in assessing the current actions of Big Pharma in promoting pharmaceutical products which are detrimental to people’s health.

Pfizer is currently involved in marketing its experimental mRNA vaccine. The FDA in an ambiguous statement has provided an Emergency Use Authorization (EUA) to the Pfizer-BioNTech COVID-19 Vaccine, while underscoring that the vaccine is “an unapproved product”.  

Here is the precise text of the FDA issued on February 25, 2021:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older. (emphasis added)

There is something “contradictory” in the FDA statement. The experimental Pfizer mRNA vaccine is “unapproved” by the FDA, yet it is “permitted”. 

For further details see:

“Fraudulent Marketing”: The Pfizer COVID-19 Vaccine Is an “Unapproved Product” which Is “Permitted for Use”

By Prof Michel Chossudovsky, March 06, 2021

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Below the text of the US Department of Justice 2009 Settlement with Pfizer, Inc.

Of relevance, the DoJ judgment required that Pfizer Inc. enter into a so-called “corporate integrity agreement” with the Office of the Inspector General of the DHHS.

The integrity agreement included procedures to ensure that Pfizer’s “conduct” would not happen again.

 

 

American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. 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 – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.

As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter. (emphasis added)

To read the entire DoJ document, click here

 

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