Pfizer ($PFE) is again facing trouble over promotions of one of its drugs. Following a two-year investigation, the pharma giant has agreed to fork over $3.34 million to Oregon for deceptive marketing claims related to the antibiotic Zyvox.
According to the state's attorney general, Pfizer used unreliable and unsubstantiated claims to promote the antibiotic, even though it lacked evidence to back up its assertions. What's more, the drugmaker touted what the attorney general's office calls "flawed clinical studies" to assert Zyvox's superiority to much less expensive vancomycin generic, which has been around for more than 40 years.
"Oregon will act when drug companies put public health at risk just to boost their profits," Attorney General John Kroger said in a release. His office notes that Pfizer's conduct could have increased the danger of microbial resistance to a second generation antibiotic while the first generation was still effective.
As part of the settlement, the $3.34 million will fully reimburse the State Accident Insurance Fund and Oregon Department of Corrections for Zyvox purchases and fund a new Consumer Education and Antimicrobial Stewardship Program.
In addition, the two parties reached a settlement regarding Pfizer's Internet marketing practices. As part of the state's 2008 settlement with Pfizer relating to its promotion of the painkiller Bextra, all of the company's promotional claims must comply with the Federal Food, Drug and Cosmetic Act. But Pfizer hasn't always followed this mandate, according to the state. Indeed, Pfizer received notice of violation letters from the FDA in March of 2009 and again in August, alleging it had promoted various drugs through the use of "sponsored links" without disclosing required risk information. As part of this most recent settlement with Oregon, Pfizer is required to comply with the FDA's interpretation of the law.
The pharma titan has been contacted by consumer protection divisions of several states regarding the promotion of Zyvox and the pain drug Lyrica, Dow Jones notes. It has been discussing possible resolution with those states.
The Oregon settlement isn't the most expensive one Pfizer has had to face, of course. That record belongs to the $2.3 billion it agreed to pay in 2009 to wrap up off-label marketing allegations involving Bextra and a basket of other drugs.
- check out the Oregon AG release
- see the Dow Jones report