The US Department of Justice said Wednesday that Pfizer agreed to pay $55 million to settle claims that its Wyeth unit promoted Protonix (pantoprazole) for unapproved uses. Additionally, the company agreed to pay a total of $42.9 million to 33 states to settle allegations that it used unfair and deceptive practices in its marketing of the antibiotic Zyvox (linezolid) and neuropathic pain treatment Lyrica (pregabalin).
The Justice Department alleged that Wyeth promoted Protonix, which was approved only for the short-term treatment of erosive oesophagitis, for all forms of gastroesophageal reflux disease from February 2000 to June 2001 despite FDA warnings that the company overstated its oesophagitis indication. Additionally, the government claimed that the company used continuing medical education materials to promote the medicine for unapproved uses. "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 US Attorney Carmen Ortiz.
Pfizer said that "resolving this investigation regarding Wyeth's historical promotional practices of Protonix is the right thing to do," adding that "in settling, we avoid both the cost and distraction of litigation and we expressly deny the allegations of wrongdoing."
In separate news, the 33 states that sued Pfizer over Zyvox and Lyrica argued that the drugmaker claimed Zyvox was superior to another antibiotic despite a lack of evidence to support the claim while they also alleged that Pfizer actively marketed Lyrica for off-label uses such as chronic pain and migraines.
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