The attorneys general of 33 states and the District of Columbia have reached a $43 million settlement with pharma giant Pfizer over allegations that the company ignored FDA warnings and made misleading marketing claims about its drugs Zyvox and Lyrica.

According to the suit, led by Texas Attorney General Greg Abbott and filed in a state district court in Dallas, Pfizer sales rep have been making unsubstantiated claims that its antibiotic Zyvox is superior to the powerful generic drug vancomycin.

The suit notes that the FDA warned Pfizer in 2005 after it ran an ad making such claims.

“Despite notifying its sales force to cease using the promotional material identified in the FDA Warning Letter, Pfizer did not provide adequate guidance to its sales force regarding what statements were permissible concerning data from head-to-head trials and retrospective analyses and what promotional statements were not permitted,” reads the complaint. “As a result, Pfizer’s sales personnel continued to make superiority claims that were inconsistent with the FDA’s Warning Letter and the FDA approved label for Zyvox.”

The attorneys general also took issue with Pfizer’s continued marketing of off-label uses for Lyrica, which was initially approved for treatment of diabetic peripheral neuropathy and post-herpetic peripheral neuropathy, and subsequently approved for treatment of fibromyalgia.

“Contrary to the approved intended uses, Pfizer marketed Lyrica for the treatment of chronic pain, neuropathic pain (other than DPN and PHN), perioperative pain, and migraine,” reads the suit.

Pfizer was also accused of encouraging its sales force to promote Lyrica as a superior to its own Neurontin (and more importantly, that drug’s generic equivalent, gabapentin). The complain alleges that Pfizer used incentive plans to push its sales force to encourage physicians to convert patients from using Neurontin to Lyrica.

As a result of this settlement, Pfizer will not only pay out $43 million to the states involved, it has also agreed to the following:
• Avoid making any false, misleading or deceptive claims when comparing the efficacy or safety of Zyvox to the generic drug Vancomycin;
• Not promote any Pfizer product for off-label uses;
• Design financial incentives that ensure its marketing personnel are not motivated to engage in the improper marketing of Zyvox or Lyrica; or
• Notify its sales force of any FDA warning letter that could affect the promotion of Pfizer products and provide a detailed explanation of the FDA warning letter to the sales representatives as to how the letter affects their promotions.

In addition to Texas and the District of Columbia, the states involved in the suit are — Arizona, Illinois, Maryland, New Jersey, Pennsylvania, South Carolina, Alabama, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Indiana, Kansas, Kentucky, Michigan, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Rhode Island, South Dakota, Tennessee, Vermont, Washington, Virginia, and Wisconsin.

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