(Phoenix, Ariz. – Sept. 2, 2009) Attorney General Terry Goddard today announced a $33 million multi-state settlement with Pfizer, Inc. regarding the drug company’s alleged improper marketing of the antipsychotic drug Geodon.
Goddard, along with Attorneys General from 41 other states and the District of Columbia, alleged that Pfizer engaged in deceptive practices when it marketed Geodon for “off-label” uses not approved by the U.S. Food and Drug Administration (FDA). In the settlement filed today, Pfizer agrees to change how it markets Geodon and agrees to not promote unapproved uses.
Arizona will receive at least $804,888 as a result of this settlement.
The settlement is separate from a record $2.3 billion federal settlement with Pfizer, also announced today, over its marketing of four products: Bextra, an anti-inflammatory drug; Zyvox, an antibiotic; Lyrica, an epilepsy drug, and Geodon.
Last October, Arizona and 31 other states reached a $60 million settlement with Pfizer over its promotion of Bextra and Celebrex, another anti-inflammatory drug. Arizona’s share of that settlement was $2.5 million.
“Companies are not at liberty to pump up their sales by promoting drugs for uses not approved by the FDA,” Goddard said. “These settlements should send a powerful message throughout the pharmaceutical industry.”
Geodon is the brand name for the prescription drug ziprasidone. The drug has been approved by the FDA for treatment of schizophrenia in adults and for manic or mixed episodes of bipolar disorder in adults.
The complaint alleges that Pfizer promoted Geodon for a number of off-label uses, including pediatric use and use at dosage levels higher than had been approved by the FDA. Although physicians may prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from actively promoting their products for any off-label use.
The settlement mandates that Pfizer shall:
- Not make any false, misleading or deceptive claims regarding Geodon.
- Not promote Geodon for off-label uses.
- Not promote Geodon using selected symptoms of FDA-approved diagnoses unless certain disclosures are made regarding all of the approved diagnoses.
- Not distribute product samples of Geodon to physicians who do not customarily treat patients with diseases for which treatment with Geodon is consistent with the product’s approved uses.
- Publicly post on its website a list of physicians and/or their related entities who receive payments from Pfizer.
- Register and post on a publicly accessible website certain Pfizer-sponsored clinical trials.
- Require that its medical staff be almost solely responsible for the identification, selection, approval and dissemination of scientific articles and reprints containing off-label information regarding Geodon, and that such information not be referred to or used in a promotional manner.
The settlement also mandates that for a six-year period, Pfizer shall:
- Disclose information on its website about grants it makes to health care providers to attend continuing medical education (CME) programs.
- Not use grants to promote Geodon, or condition CME funding on Pfizer’s approval of speakers or program content.
- Contractually require continuing CME program providers to disclose Pfizer’s financial support of their programs and any financial relationship with faculty and speakers.
Tucson-based Assistant Attorneys General Noreen Matts and Taren Ellis served on the executive committee negotiating this settlement. The participating states in the settlement are: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.