Offer an alternative question that you might have asked the legal expert on this project.

 

 

Pfizer Inc. and Pharmacia & Upjohn Company Inc. have agreed to pay a $2.3 billion settlement to resolve their criminal and civil liability related to illegally marketing pharmaceutical products (Justice Department announces largest health care fraud settlement in its history, 2014). They plead "guilty to a felony violation of the Food, Drug, and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead" users (Justice Department announces largest health care fraud settlement in its history, 2014). Bextra was an anti-inflammatory drug that was pulled from the market in 2005 by Pfizer. The FDA declined Bextra due to safety concerns, but Pfizer promoted the usage of Bextra anyways. Before any drug can be sold and marketed it is required that it goes "under the provisions of the Food, Drug, and Cosmetic Act" and information is filled out on the new drug application to the FDA (Justice Department announces largest health care fraud settlement in its history, 2014). If the drug is then approved by the FDA, the drug may not be promoted or marketed for any uses that were not specific on the application approved by the FDA. Pfizer did not adhere to these laws, which led them to pay a criminal fine of $1.195 billion, one of the largest criminal fines ever imposed in the US (Justice Department announces largest health care fraud settlement in its history, 2014). Not only was it found that Pfizer illegally marketed one drug, but they illegally marketed four drugs, Bextra; Geodon; Zyvox; and Lyrica that were submitted under false claims to government health care programs. This resulted in Pfizer having to pay another "$1 billion to resolve allegations under the civil False Claims Act" (Justice Department announces largest health care fraud settlement in its history, 2014). The overall consequences for their illegal marketing practices were financial penalties of $2.3 billion, loss in reputation, and an increase in regulatory scrutiny. 

 

The illegal marketing practice of Pfizer affected the promotion element of the marketing mix. It is clear that Pfizer engaged in an illegal and untruthful promotion through marketing their pharmaceutical products for off-label uses, that were not approved by FDA. Pfizer violated laws and regulations by engaging in off-label promotions that misled healthcare providers and the public to believe the drug was safe and effective. When marketing it is important to follow the law and be truthful and honest when promoting products, unfortunately, Pfizer broke that law which affected the promotion element in the marketing mix. 

 

If I were the marketing professional assigned to this project, I would have asked a few questions to ensure the project was on the right track and that we were complying with the laws and regulations of the industry. 

1. Are the promotional materials and messages we use to promote our products in compliance with FDA rules and regulations?
2. What are the legal restrictions and requirements for sales promotions and advertising for pharmaceutical products?

 

Reference:

Justice Department announces largest health care fraud settlement in its history. The United States Department of Justice. (2014, September 16). https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history.