Off-Label Marketing Case Settled by Pfizer for $55M

report off label promotion

For off-label marketing of the drug Protonix and other fraudulent conduct, Pfizer has agreed to pay $55 million in its settlement with the United States Department of Justice. Protonix is an acid reflex drug produced by Wyeth, which is owned by Pfizer.

Off-label marketing

“Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses,” stated U.S. Attorney Carmen Ortiz.

The Food and Drug Administration only approved Protonix for a particular kind of gastro-esophageal reflux disease (GERD) that can only be diagnosed via endoscopy. But, according to the DOJ, Wyeth trained its marketers to promote Protonix for every kind of GERD. By opening up the drug for far more common uses, Wyeth could greatly increase profits.

The government also alleged that Wyeth used continuing medical education (CME) programs for doctors for off-label marketing of Protonix.  According to the DOJ, Wyeth spent millions of dollars funding the CME programs.  Such programs are taught at universities, non-profits, and medical societies.  Despite rules against influencing the content of the programs:

“The Protonix “brand team” influenced virtually every aspect of these CME programs: program topics, speaker selection, organization, and content. In addition, the government alleges that Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials–a tactic that Wyeth and the vendor called “branducation.” source: DOJ press release

Deceptive Slogan

The DOJ also alleged that Wyeth marketed Protonix as the “best PPI for nighttime heartburn.” But there was no evidence to support that claim. Despite having no proof that Protonix was more effective than other proton pump inhibitors (PPI’s), Wyeth trained its salesforce to promote the slogan.

In settling the case, Pfizer denies all allegations.

If you have first hand information about off-label marketing or other health care fraud, a whistleblower attorney can help determine whether you have a case.  We can guide you through the steps that need to be taken.  Call 1-877-255-2676 today for a free, confidential consultation or contact us.

For additional off-label marketing cases, or to report off-label marketing, see our pharma fraud page.


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