TRENTON—Attorney General Anne Milgram announced Wednesday that New Jersey has entered into a multi-state settlement agreement with Pfizer Inc. that resolves allegations the pharmaceutical maker improperly marketed its antipsychotic drug Geodon.
In addition to requiring that Pfizer make certain changes in its approach to marketing Geodon, the settlement also requires Pfizer to pay New Jersey $943,230.
The participating states charged that Pfizer engaged in unfair and deceptive practices when it marketed Geodon for certain “off label” uses. Off label uses are those which have not been approved by the U.S. Food and Drug Administration (FDA.)
As part of the settlement, Pfizer has agreed to change the way it markets Geodon and has also agreed not to promote off label uses.
Geodon is the brand name for the prescription drug ziprasidone. Ziprasidone has been approved by the FDA for treatment of schizophrenia in adults, and for manic or mixed episodes of bi-polar disorder in adults.
The state’s complaint charges that Pfizer improperly promoted Geodon for pediatric use and for use at dosage levels higher than those approved by the FDA. Both applications of the drug are not approved by the FDA and, as such, are considered off-label uses.
Although a physician is allowed to prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from promoting and marketing their products for such uses.
The multi-state settlement announced Wednesday requires that Pfizer not make any false, misleading or deceptive claims regarding Geodon. Pfizer has also agreed not to promote Geodon for off-label usage.
In addition, the settlement mandates that Pfizer:
• Post on its web site a list of physicians and related entities who receive payments from Pfizer until the year 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 and post on a publicly accessible web site certain Pfizer-sponsored clinical trials
• Require its medical staff to be responsible for the identification, selection, approval and dissemination of scientific article reprints containing off-label information about Geodon, and also that such information not be referred to or used in a promotional manner.
The settlement also mandates that, for a nine-year time period (which extends beyond the patent term for Geodon), Pfizer must require its medical staff – not its marketing staff – to have ultimate responsibility for developing and approving the medical content for all medical letters concerning Geodon.
For a six-year period, Pfizer must:
• Disclose on its web site information about grants it makes to health care providers, including continued medical education grants
• Not use grants to promote Geodon, or tie the funding of continued medical education to Pfizer’s approval of speakers and/or program content
• Contractually require continuing medical education providers to disclose Pfizer’s financial support of their programs, as well as any financial relationship with faculty and speakers
In addition to New Jersey, 41 other states and the District of Columbia are party to the overall $33 million settlement with Pfizer, including Maryland and Delaware, who led the multi-state executive committee that negotiated with Pfizer.
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