Wednesday, December 12, 2012
The multi-state investigation also discovered that Pfizer unlawfully promoted Lyrica for off-label uses, which are uses not approved by the U.S. Food and Drug Administration (FDA). The investigation found evidence that Pfizer marketed Lyrica as a treatment for types of neuropathic pain other than those indicated and approved by the FDA.
Under today’s agreement and the resulting consent judgment, Pfizer must reform how it markets and promotes Zyvox and Lyrica. Specifically, Pfizer Inc. must:
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.