For Immediate Release
Media Contact: Bob Cooper
(208) 334-4112
Date: September 3, 2009
State Announces Second Settlement with Pfizer to Change Marketing of Geodon and Pay States $33 Million
(Boise) - The State of Idaho will receive $489,448 as a result of a settlement with Pfizer Inc. related to the alleged improper marketing of the antipsychotic drug Geodon, Attorney General Lawrence Wasden said. Wasden joined with the attorneys general of 42 other states in negotiating the settlement, which is subject to court approval. This is a separate settlement from the Medicaid fraud settlement announced yesterday.
The attorneys general alleged 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 not to promote “off-label” uses, which are uses not approved by the U.S. Food and Drug Administration (FDA).
“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,” Attorney General Lawrence Wasden said.
Geodon is the brand name for the prescription drug ziprasidone. The drug has been approved by the FDA for treatment of adults with schizophrenia and for manic or mixed episodes of bipolar disorder. However, the states alleged that Pfizer promoted Geodon for pediatric use and for use at higher than FDA-approved dosages.
Other settlement terms mandate that Pfizer shall:
- Not make any false, misleading or deceptive claims regarding Geodon;
- Not promote Geodon for off-label uses;
- 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; and
- Post on a publicly accessible website all Pfizer-sponsored Geodon Phase II, III and IV clinical trials completed after October of 2002.
The settlement also mandates that, for nine years, 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; and
- Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information regarding Geodon.
- Additionally, for the next six years, Pfizer must:
- Disclose information about grants, including continued medical education grants (CME), 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 CME providers to disclose Pfizer’s financial support of their programs and any financial relationship with faculty and speakers.
Idaho’s share of the settlement will be deposited into the Consumer Protection Account for use in consumer protection education and enforcement activities.
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