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Pfizer (PFE) To Pay $55M Over Off-Label Use Of Wyeth's Protonix

 December 12, 2012 02:44 PM
 


(By Balachander) Pfizer Inc. (NYSE: PFE) will pay $55 million to resolve allegations that Wyeth LLC illegally promoted Protonix drug for unapproved uses, the Justice Department said.

Wyeth, which Pfizer acquired in 2009, obtained approval from the Food and Drug Administration (FDA) 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," the Justice Department said.

[Related -Pfizer Inc. (PFE) Q3 Earnings Preview: What To Watch?]

The government alleged that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication, and that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD.

"Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses," said U.S. Attorney Carmen Ortiz. "Wyeth ignored the FDA's warning not to promote Protonix off-label, and then went so far as to contaminate CME programs that physicians rely on for unbiased, independent scientific information."

The stock, which has been trading in the 52-week range of $20.51 to $26.09, inched 0.20 percent higher to trade at $25.69 on Wednesday.

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