Agreement marks the largest ever consumer drug settlement reached independently by the Oregon Department of Justice
Attorney General John Kroger today announced a $3.34 million agreement with the world's largest research-based pharmaceutical company, Pfizer, Inc., over allegedly deceptive marketing claims related to its prescription drug Zyvox®. This is the largest ever consumer drug agreement that Oregon has achieved with a prescription drug manufacturer.
"Oregon will act when drug companies put public health at risk just to boost their profits," said Attorney General Kroger.
Today's settlement follows a two-year investigation by the Oregon Department of Justice into evidence that suggested Pfizer was using unreliable and unsubstantiated claims to promote Zyvox®, a relatively new and expensive antibiotic used for treating certain types of pneumonia and bacterial skin infections. Despite lacking evidence required by the Food and Drug Administration (FDA) to make such claims, Pfizer allegedly relied upon flawed clinical studies to substantiate assertions that Zyvox® was a superior to vancomycin, a comparatively inexpensive generic drug that holds the largest market share and has been available for more than 40 years. Pfizer's sales representatives detailed and distributed thousands of copies of these faulty studies throughout Oregon to promote the sale of Zyvox®.
Besides threatening the pocketbooks of consumers by misrepresenting that an expensive branded drug was superior to an existing generic, Pfizer's conduct was a potential threat to public health because it increased the danger of microbial resistance to a second generation antibiotic while the first generation antibiotic was still effective. To conserve the effectiveness of new antibiotics for the time when microbes inevitably develop resistance to antibiotics, infectious disease specialists advise using older antibiotics while they are still effective while holding the newer antibiotics in reserve. This is called "antimicrobial stewardship."
Under the settlement filed today in Marion County Circuit Court, Pfizer must pay over $3.34 million to Oregon to fully reimburse the State Accident Insurance Fund and Oregon Department of Corrections for purchases they made of Zyvox and to fund a new Consumer Education and Antimicrobial Stewardship Program administered by the Oregon Public Health Division/Office of Disease Prevention and Epidemiology and the Oregon Patient Safety Commission. Over $617,000 of the settlement fund will finance efforts to promote antimicrobial stewardship in Oregon and to teach consumers about proper use of antibiotics. The remainder of the settlement money will be deposited into the Protection and Education Account to fund the state's consumer protection activities. The agreement also provides for injunctive relief that will prevent similar future misconduct with respect to other Pfizer drugs.
In addition to the Zyvox settlement, Oregon also reached a settlement with Pfizer relating to its Internet marketing practices. Under Oregon's 2008 settlement with Pfizer relating to the promotion of its pain killer Bextra, all Pfizer promotional claims are required to comply with the federal Food, Drug and Cosmetic Act (FDCA). However, following the Bextra settlement, Pfizer received notice of violation letters from FDA on March 26, 2009 and again on August 31, 2011 alleging that Pfizer violated the FDCA by promoting various drugs through the use of "sponsored links" without disclosing required risk information. Under today's settlement, Pfizer is required to comply with FDA's interpretation of the law. This is the first time a state has moved to enforce a consumer protection settlement with Pfizer.
Senior Assistant Attorney General David Hart, Assistant Attorney in Charge of Financial Fraud/Consumer Protection, handled both cases for the Oregon Department of Justice.
Attorney General John Kroger leads the Oregon Department of Justice. The Department's mission is to fight crime and fraud, protect the environment, improve child welfare, promote a positive business climate, and defend the rights of all Oregonians.
Tony Green, (503) 378-6002 firstname.lastname@example.org