Pfizer to pay $55 million in Protonix lawsuit settlement over claims Wyeth illegally promoted drug for unapproved uses

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by Eric Pearson

The world’s largest drug maker, Pfizer Inc., will pay $55 million plus interest to settle charges by the U.S. Department of Justice that the acid reflux drug Protonix was promoted for unapproved uses. The allegations are based on the conduct of Wyeth in 2000 and 2001. Pfizer acquired Wyeth in 2009 for $68 billion.

Protonix belongs to a class of widely used medicines called proton pump inhibitors (PPI). Protonix was approved by the FDA for short-term treatment of erosive esophagitis -a condition related to gastro-esophageal reflux disease, or GERD, that can only be diagnosed via endoscopy.

According to the Justice Department, even though the drug was only approved for a limited purpose, Wyeth trained its sales force to promote Protonix for all forms of GERD. By promoting the drug as appropriate for far more commonly diagnosed forms of GERD, Wyeth was aiming for significantly higher sales.

Before Wyeth before the company even began promoting Protonix, the FDA had warned the company that its proposed promotional materials were misleading. Wyeth was warned that it had “overstated” its “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD, according to the FDA. ” Wyeth was also warned that “Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.” Despite the FDA warnings, Wyeth actively promoted Protonix for uses that were not approved by the FDA.

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

Wyeth also allegedly promoted Protonix as the “best PPI for nighttime heartburn.” However, there was never any clinical evidence that it was more effective than any other PPI for nighttime heartburn.

The Justice Department also alleged that Wyeth spent millions of dollars to fund continuing medical education programs to promote Protonix for unapproved uses. Such programs are sponsored by universities, nonprofit organizations, or specialty societies and supported by grants from pharmaceutical companies. According to the Justice Department, one of Wyeth’s “core marketing tactics” for Protonix was to use such programs “to drive off-label use of the drug.” According to the complaint, Wyeth influenced virtually every aspect of these programs: program topics, speaker selection, organization, and content.

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