Attorney General Greg Zoeller says Indiana will receive part of a $35 million dollar settlement with New York-based Pfizer Inc. (NYSE: PFE). The settlement stems from allegations that the drug Rapamune was unlawfully promoted. August 6, 2014

News Release

INDIANAPOLIS, Ind. — Indiana is set to receive $720,000 as a result of a $35 Million multi-state consumer settlement Attorney General Greg Zoeller entered into with Pfizer Inc, a parent of Wyeth Pharmaceuticals Inc. The terms of the settlement require that the funds be used for consumer education related purposes.

The settlement, reached by Zoeller, 41 other attorneys general and Pfizer resolves allegations that Wyeth unlawfully promoted Rapamune, an immunosuppressive drug currently approved by the FDA as prophylactic for organ rejection after kidney transplant surgery.

Zoeller said pharmaceutical companies can only promote a drug for the uses approved by the U.S. Food and Drug Administration (FDA), but doctors are free to prescribe the drug for other uses. According to the Complaint and Consent Judgment filed today, Wyeth violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, including the unapproved use of Rapamune following an organ transplant other than a kidney transplant, the unapproved protocol of converting patients to Rapamune after initially receiving a different immunosuppressive drug, and using Rapamune in unapproved drug combinations.

“Pharmaceutical companies that use off-label marketing to promote a prescription drug to boost sales are putting patients at an unnecessary risk,” Zoeller said. “Promoting a drug for uses other than what has been approved by the FDA is a serious offense that will not be tolerated.”

The Consent Judgment also requires Pfizer to ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any Pfizer product. Specifically, Pfizer shall not:

-Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive regarding any Pfizer Product;

-Make any claim comparing the safety or efficacy of a Pfizer Product to another product when that claim is not supported by substantial evidence as defined by Federal law and regulations;

-Promote any Pfizer Product for Off-Label uses;

-Include mechanisms in its financial incentives to provide incentive compensation for sales that may be attributable to the Off-Label uses of any Pfizer Product;

-Affirmatively seek the inclusion of Rapamune in hospital protocols or standing orders unless Rapamune has been approved by the FDA for the indication for which it is to be included in the protocol or standing order;

-Disseminate information describing any Off-Label or unapproved use of Rapamune unless such information and materials comply with applicable FDA regulations and the recommended actions in FDA Guidances for Industry; or

-Seek to influence the prescribing of Rapamune in hospitals or transplant centers in any manner (including through funding clinical trials) that does not comply with the Federal anti-kickback statute.

Other states participating in the settlement are Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

Attorney General Greg Zoeller thanks Deputy Attorney General Luminita Nodit for her work on this case.

Source: Office of Indiana Attorney General Greg Zoeller

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