Pfizer agrees $55 million settlement for off-label promotion of Protonix by Wyeth; strikes deal over Zyvox and Lyrica

USA-based Pfizer (NYSE: PFE), the world’s largest drugmaker by sales, has agreed to pay $55 million plus interest to resolve allegations that Wyeth (which it acquired in 2009 for $68 billion) illegally introduced and caused the introduction into interstate commerce of a misbranded drug, Protonix (pantoprazole), between February 2000 and June 2001, the US Justice Department announced yesterday.

Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD). Wyeth sought and obtained approval from the Food and Drug Administration to promote Protonix for short-term treatment of erosive esophagitis - a condition associated with GERD that can only be diagnosed with an invasive endoscopy. However, the government alleges that Wyeth fully intended to, and did, promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without an endoscopy.

Settles to avoid both cost and distraction of litigation

According to Reuters, Pfizer issued a statement saying that it was not the target or subject of this case, but felt that settling it was in its best interest. "Resolving this investigation regarding Wyeth's historical promotional practices of Protonix is the right thing to do. In settling, we avoid both the cost and distraction of litigation and we expressly deny the allegations of wrongdoing," the company said.