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Bill Cosh 608/266-1221
MADISON – Attorney General J.B. Van Hollen announced today that he, along with 42 other Attorneys General, reached a $33 million dollar settlement with Pfizer Inc. related to the alleged improper marketing of the antipsychotic drug Geodon. In a complaint soon to be filed in court along with the settlement agreement, Attorney General J.B. Van Hollen alleges that Pfizer engaged in unfair and deceptive practices when it marketed Geodon for off-label uses. Pfizer has agreed to change how it markets Geodon and to cease promoting its “off-label” uses, which are not approved by the U.S. Food and Drug Administration (FDA).
“Companies who do business in Wisconsin must follow our consumer protection laws. Together with my fellow Attorneys General, I will continue to monitor the industry for inappropriate and illegal promotion of off-label products,” said Attorney General J.B. Van Hollen.
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. However, Pfizer promoted Geodon for a number of off-label uses, including promoting Geodon for pediatric use and for use at higher than FDA-approved dosages. While a physician is allowed to prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
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 the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
* Post on its website a list of physicians and related entities who received payments from Pfizer until 2014;
* Provide product samples of Geodon only to health care providers who have specialties that customarily treat patients who have diseases for which treatment with Geodon would be consistent with the product’s current labeling;
* Register clinical trials and submit results as required by federal law; register Geodon Pfizer-sponsored Phase II, III and IV clinical trials ongoing or initiated after July 1, 2005; and post on a publicly accessible website all Pfizer-sponsored Phase II, III and IV clinical trials completed after October of 2002; and
* Require its medical staff to be responsible for the identification, selection, approval and dissemination of article 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 nine-year time period extending beyond the patent term for Geodon, Pfizer shall:
* Require its medical staff, rather than its marketing staff, to have ultimate responsibility for developing and approving the medical content for all medical letters regarding Geodon, including those that may describe off-label information. This information shall not be distributed unless certain criteria are met; and
* Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information regarding Geodon.
For a six-year period, Pfizer must:
* Disclose information about grants, including continued medical education grants, on its website, for at least two years and maintain the information for five years;
* Not use grants to promote Geodon, or condition CME funding on Pfizer’s approval of speakers or program content; and
* Contractually require continuing medical education providers to disclose Pfizer’s financial support of their programs and any financial relationship with faculty and speakers.
The State of Wisconsin will receive $749,600 as a result of this settlement.
The Attorneys General from Delaware and Maryland led the Executive Committee States’ negotiation of the settlement of Pfizer’s marketing and promotional practices. The Executive Committee States include Arizona, Colorado, Delaware, District of Columbia, Florida, Kentucky, Maryland, Massachusetts, North Carolina, Ohio, and Pennsylvania. The participating states in the settlement are: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
Assistant Attorney General Lara Sutherlin handled the case for the State of Wisconsin.