REPORT FROM DCCA – Hawaii, 31 other states and the District of Columbia reached a $42.9 million settlement with Pfizer Inc. to resolve allegations that Pfizer Inc. unlawfully promoted its drugs, Zyvox® and Lyrica®, Department of Commerce and Consumer Affairs’ (DCCA) Office of Consumer Protection (OCP) Executive Director Bruce Kim announced today.The states allege that Pfizer Inc. engaged in unfair and deceptive practices by making misleading and unsubstantiated superiority claims that broadened the uses for Zyvox®, an antibacterial agent approved to treat certain types of infections. The drug is approved to treat nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (“MRSA”) and complicated skin and skin structure infections due to MRSA. Moreover, the states allege that Pfizer Inc. engaged in unfair and deceptive practices in promoting Lyrica® for off-label uses.
“Consumers in Hawaii have the right to expect that their health and well-being – and not profit – drives decisions about their care,” Kim said. “This settlement protects consumers by putting an end to the unscrupulous marketing of Zyvox based on unsubstantiated claims and stops questionable practices which promoted Lyrica for unapproved off-label uses.”
As part of a stipulated judgment entered in the Hawaii case, Pfizer Inc. agreed to reform how it markets and promotes Zyvox® and Lyrica®. Pfizer Inc. agreed that it shall not:
· Make any false, misleading, or deceptive claims when comparing the efficacy or safety of Zyvox® to 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 in the promotion of Pfizer products.
Hawaii will receive $688,105 as its share of the settlement.
“Patients’ interests must come first. Making unsubstantiated claims to increase sales of Zyvox or promoting any Pfizer drug for unapproved, off-label uses is strictly forbidden under this settlement,” Kim said.
The investigation was led by the Attorney General of Texas with an Executive Committee consisting of the Attorneys General of Arizona, Illinois, Maryland, New Jersey, Pennsylvania, and South Carolina. Also participating in the settlement are Alabama, Arkansas, California, Colorado, Delaware, the District of Columbia, 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.
Lisa Tong, a senior staff attorney at the Office of Consumer Protection, represented Hawaii in this case.