OLYMPIA… Attorney General Rob McKenna today joined 42 other state Attorneys General in announcing a $33 million agreement with Pfizer Inc. related to the drug company’s alleged improper marketing of the antipsychotic drug, Geodon.
In a consumer protection complaint soon to be filed in court along with the settlement agreement, McKenna alleges Pfizer engaged in unfair and deceptive practices when it marketed Geodon for off-label uses, which are uses that have not been approved by the U.S. Food and Drug Administration (FDA). Pfizer has agreed to change how it markets Geodon and has agreed not to promote “off-label” uses.
“This case is consistent with the related case today in that it demonstrates once again, that drug companies will be held accountable and we will not tolerate “off-label” marketing,” McKenna said.
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 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 Web site a list of physicians and related entities who receive 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 and post on a publicly accessible Web site certain Pfizer-sponsored clinical trials; and
Require its medical staff to be responsible for the identification, selection, approval and dissemination of scientific 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 (which extends 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.
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 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 Washington will receive roughly $880,000 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, Delaware, 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.
Assistant Attorney General Robert Lipson handled this second case for Attorney General McKenna’s Consumer Protection Division.
Geodon Complaint - Filed 9/9/09
Geodon Consent Decree - Filed 9/9/09
Janelle Guthrie, AGO Communications Director, (360) 586-0725
Kristin Alexander, AGO Seattle Media Relations Manager, (206) 464-6432