Pfizer Inc. will shell out $55 million plus interest to resolve allegations that Wyeth, a company acquired by the drug maker in 2009, illegally marketed a misbranded drug for off-label use, federal prosecutors in Boston said today.
Wyeth manufactured and promoted Protonix, a proton pump inhibitor used by physicians to treat various forms of gastro-esophageal reflux disease, prosecutors said. Wyeth allegedly sought and obtained approval from the U.S. 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.
Under the Federal Food Drug and Cosmetic Act, a drug is misbranded if its labeling does not bear adequate directions for safe use and for the purposes for which it is intended. Before Wyeth even began promoting Protonix, the FDA warned the company its proposed promotional materials were misleading. Despite this, the company allegedly trained its sales force to promote the drug for all forms of GERD, prosecutors said.
Wyeth also promoted the drug as the "best PPI for nighttime heartburn," even though no clinical evidence supported that claim, prosecutors said, adding the company also used continuing medical education programs to promote Protonix for unapproved uses.
Wyeth allegedly introduced and caused the introduction into interstate commerce of Protonix between February 2000 and June 2001, prosecutors said, adding the claims settled by the agreement are allegations only, ones which Pfizer denies.
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