Cross-posted by Forbes.com at WLF’s contributor page
Pharmaceutical companies’ promotions of their products continues to be an area of intense activity for several federal government agencies. Such focused federal attention makes it easy for all interested parties, perhaps including drug makers themselves, to overlook the states’ involvement in the area of pharmaceutical promotion. A settlement last month between the Oregon Department of Justice and Pfizer, which has received very little attention, is a stark reminder that many states are also keenly interested in pharmaceutical promotions.
The March 20, 2012 “Assurance of Voluntary Compliance” document arose out of Oregon’s involvement in a federal investigation of, and eventual settlement with, Pfizer regarding off-label “promotion” and other promotional activities. The September 2009 $2.3 billion settlement stemmed from Pfizer’s promotion of a number of drugs, including painkiller Bextra and Zyvox, an antibiotic.
An Oregon DOJ press release relates that a two-year investigation indicated that Pfizer was relying on “unreliable and unsubstantiated claims” to promote Zyvox as being more effective than a competing product. As the state investigation’s leader noted to a reporter, “Our investigation was aggressive, detailed, went places that the federal settlement didn’t and provided additional settlement to the state of Oregon.”
The compliance document requires Pfizer to pay $3,341,642 to the State of Oregon. The company also agreed to a number of other remedies. First, Pfizer agreed to refrain from promoting Zyvox in a false or misleading manner. Second, it will disclose payments or other transfers of value made to Oregon-based nurse practitioners. Third, Pfizer will disclose payments made to authors of Zyvox studies, reports, and clinical guidelines. Finally, the company must submit to the ClinicalTrials.gov website all clinical trial results that are Pfizer-sponsored Zyvox trials. If Pfizer and any other state enter into an agreement related to Zyvox promotion, Oregon can add to the agreement any additional terms that Pfizer agrees to with those other states.
These types of settlement terms have certainly become routine in federal “corporate integrity agreements” and other documents that accompany the settlement of federal allegations of alleged health care fraud. But the Oregon settlement shows that states are often willing and able to piggyback onto federal actions and expand past federal investigations to extract their own financial and conduct remedies.