WASHINGTON, DC – District of Columbia Attorney General Irvin B. Nathan announced today that the District and 32 states reached a $42.9 million settlement with Pfizer Inc. to resolve allegations that Pfizer unlawfully promoted its drugs, Zyvox and Lyrica. The District’s share of the settlement is $609,515.
Zyvox is an antibacterial agent approved by the US Food and Drug Administration to treat certain types of infections, including nosocomial pneumonia caused by Methicillin-Resistant Staphylococcus Aureus (“MRSA”), and complicated skin and skin structure infections due to MRSA. In complaints filed in the District and state courts today, the Attorneys General allege that Pfizer, in violation of state consumer protection laws, engaged in deceptive practices in its promotion of Zyvox by making unsubstantiated superiority claims, and by marketing the drug for unapproved uses.
The complaints allege that Pfizer also marketed a second drug, Lyrica, for unapproved uses. Although Lyrica was approved by the FDA to treat specific types of pain, such as diabetic nerve pain (Diabetic Peripheral Neuropathy), Pfizer unlawfully marketed the drug for other types of pain, without having received FDA approval for such uses, the complaints charge.
In the settlement, Pfizer agreed to entry of a consent judgment governing how it markets and promotes Zyvox and Lyrica. It is a violation of the consent judgment for Pfizer to:
- Make any false, misleading, or deceptive claims when comparing the efficacy or safety of Zyvox to its generic equivalent, vancomycin;
- Promote any Pfizer product for off-label uses;
- Fail to design financial incentives that ensure that its marketing personnel are not motivated to engage in the improper marketing of Zyvox or Lyrica; or
- Fail to notify its sales force promptly of any warning letter received from the FDA that affects sales representatives’ promotion of Pfizer products.
“Consumers have a right to truthful, non-misleading information about the products they are buying, especially those that are as important to their health and well-being as prescription drugs are. This consent judgment will help protect that right,” Attorney General Nathan said.
- Ted Gest (202) 727-6283