(Phoenix, Ariz. – October 22, 2008) Attorney General Terry Goddard announced a $60 million settlement today with Pfizer Inc. (Pfizer). The settlement resolves a lengthy investigation by Attorneys General from 32 states and the District of Columbia into the company’s promotion of the drugs Celebrex® and Bextra®.
Arizona’s share of the $60 million payment is $2,500,656. The settlement takes the form of a consent judgment and does not constitute an admission of wrongdoing.
“This judgment sends a strong message to the pharmaceutical industry: We will not tolerate deceptive or misleading drug promotion,” Goddard said.
The states initiated the investigation to determine whether Pfizer misrepresented its non-steroidal anti-inflammatory (NSAIDS) drugs Celebrex and Bextra as safer and more effective than traditional NSAIDS. Traditional NSAIDS, such as Ibuprofen (Advil®) and naproxen (Aleve®), are used to treat pain and inflammation. However, they also have the potential to cause serious gastro-intestinal (GI) side effects.
The states alleged that, contrary to Pfizer’s claims, neither Celebrex nor Bextra were more effective than traditional NSAIDS at relieving pain or reducing serious GI side effects. Furthermore, the drugs allegedly increased the risk of serious cardiovascular problems, such as heart attacks and strokes.
According to the complaint, Pfizer also engaged in an aggressive, deceptive and unlawful campaign to promote Bextra for “off-label” uses that were unapproved by the U.S. Food and Drug Administration (FDA), including treatment of acute and post-surgical pain.
The settlement also requires Pfizer to submit all “direct-to-consumer” television drug advertisements to the FDA for approval and to comply with any FDA revisions before running the advertisement.
The settlement also requires Pfizer to register all clinical trials and post clinical trial results and to ensure that Pfizer provides subjects in clinical trials adequate informed consent.
Joining Arizona in today’s settlement are: Alaska, Arkansas, California, Connecticut, Florida, District of Columbia, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.
Assistant Attorney General Noreen R. Matts handled this matter and served as a co-chair of the multi-state negotiating team. For additional information, contact Anne Hilby at (602) 542-8019.