Editor's Note: The following is a press release issued this week from the office of Washington State Attorney General Rob McKenna.
SEATTLE – Washington State Attorney General Rob McKenna this week announced that he and 33 other state attorneys general reached a $42.9 million settlement with Pfizer Inc. to resolve allegations that the company unlawfully promoted its drugs, Zyvox and Lyrica.
“Pfizer’s claims about Zyvox and Lyrica were not supported by scientific evidence,” said McKenna. “Pfizer’s marketing of these drugs was deceptive. They misled healthcare providers and unfairly competed with companies playing by the rules.”
The attorneys general allege that Pfizer engaged in unfair and deceptive practices by making misleading and unsubstantiated claims about the drugs’ superiority to similar, better-known drugs. The Food and Drug Administration (FDA) approved Zyvox to treat, among other conditions, pneumonia and skin infections caused by Methicillin-resistant Staphylococcus Aureus (MRSA). Pfizer promoted Zyvox as superior to Vancomycin, an effective and well-known MRSA drug. Lyrica is FDA-approved for seizure control and nerve pain in diabetics, among other illnesses. Pfizer marketed the drug as a more potent successor to Neurontin, another drug that has been used effectively for years.
In addition, McKenna and his colleagues say the drug maker engaged in illegal marketing for Lyrica by encouraging its use for the treatment of pain conditions for which the drug is not approved by the FDA. Such promotion of drugs is called “off-label” marketing.
In 2009, to end civil and criminal federal investigations, Pfizer pled guilty to criminal charges relating to their intent to defraud or mislead healthcare providers. As a part of the federal settlement, Pfizer made admissions regarding its claims of superiority of Zyvox over Vancomycin, including claims that were not supported by scientific evidence.
The investigation also pointed out that the FDA sent out a 2005 warning to Pfizer that their advertisement misbranded Zyvox and omitted safety information. It is a federal crime to misbrand drugs in such a way that healthcare organizations are deceived. Pfizer admitted that, despite notifying its sales force to cease using the promotional material identified in the FDA warning letter, it did not provide adequate guidance regarding which statements were allowed. As a result, Pfizer’s sales people continued to make superiority claims that were inconsistent with the FDA’s warning letter and Zyvox’s FDA-approved label.
As part of the settlement – a consent judgment filed in King County Superior Court – Pfizer agrees to reform how it markets and promotes Zyvox and Lyrica. Pfizer agrees not to:
- Make 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;
- Fail to notify its sales force promptly of any warning letter received from the FDA that affects the promotion of Pfizer products.
A small portion of Washington state’s $1.3 million share of the settlement will be used to cover attorneys’ fees and costs associated with the investigation. The rest will be made available as grants to organizations set up to help those who suffer from diabetes.
Payment amounts to individual states were calculated using the following formula: 45 percent of the payment is based on population; 43 percent is divided equally among the states; 10 percent is divided among states that ran the investigation; and 2 percent is divided among states, including Washington, that assisted in reviewing case documents.
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, Virginia, and Wisconsin.