Des Moines, Sept. 2, 2009. Pfizer Inc. must change its marketing practices and pay $33 million to 43 states under a settlement resolving allegations by state attorneys general that Pfizer used unfair and deceptive practices in marketing its anti-psychotic drug called “Geodon.”
“The FDA approved Geodon for treatment of schizophrenia in 2001,” Iowa Attorney General Tom Miller said. “But we allege Pfizer also marketed the drug illegally for uses not approved by the FDA, including for use with pediatric patients and for higher than FDA-approved dosages.
“Marketing for such so-called ‘off-label’ uses amounts to misrepresentation of the drug’s safety and effectiveness,” Miller said. “We alleged that was an unfair and deceptive practice and a violation of our state consumer protection laws.”
Pfizer resolved the states’ allegations by agreeing to numerous requirements on how it markets Geodon, agreeing not to promote Geodon for “off-label” uses, and making a payment of $33 million to the 43 states that are signing on to the settlement with the giant drug company.
Iowa’s share of the settlement payment will be $583,000. The funds must be used for costs of the Pfizer case and for ongoing consumer protection enforcement, litigation and education.
The settlement with Pfizer must be approved by state courts in the 43 states and territories. In Iowa, the Attorney General’s Office will file a lawsuit in Polk County District Court and simultaneously present the Court with a proposed order resolving the lawsuit and ordering Pfizer to make the marketing changes and payment in its agreement with the states.
Miller said it is important for anti-psychotic drugs like Geodon not to be marketed for ‘off-label’ uses because they can have dangerous side effects including diabetes, cardiovascular complications, weight gain, hyperglycemia, and other severe conditions. Physicians are allowed to prescribe drugs for off-label uses, but pharmaceutical manufacturers are prohibited from marketing their products for off-label uses.
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More background and detail:
States participating in the settlement are: AL, AR, AZ, CA, CO, CT, DE, FL, HI, ID, IL, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WV, WI, and the District of Columbia. Delaware and Maryland led the States’ negotiation of the settlement with Pfizer.
Under the settlement with the States, Pfizer must:
- 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 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 website 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.