Attorney General Bob Cooper and acting director of the Division of Consumer Affairs Bill Giannini today announced a settlement with Pfizer Inc. resolving allegations regarding the unlawful marketing of the drug Rapamune. Pfizer, as parent of Wyeth Pharmaceuticals Inc., agrees to be bound by the judgment to resolve allegations that Wyeth unlawfully promoted Rapamune, an immunosuppressive drug currently approved by the FDA as a prophylactic for organ rejection after kidney transplant surgery.
The complaint and agreed final judgment filed today allege that Wyeth violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, including making representations related to: (1) the unapproved use of Rapamune following an organ transplant other than a kidney transplant; (2) the unapproved protocol of converting patients to Rapamune after initially receiving a different immunosuppressive drug; and (3) using Rapamune in unapproved drug combinations. Tennessee will receive over $700,000 as a result of this consumer protection investigation.
"I appreciate the cooperative work of all the states participating in this consumer protection settlement," Attorney General Cooper said. "My office remains vigilant in its efforts to stop deceptive marketing practices by some drug companies which may lead to unnecessary health risks of Tennesseans."
"The Department of Commerce and Insurance is pleased to continue efforts that protect Tennesseans from unlawful practices," Commissioner Julie Mix McPeak said. "We strive to ensure all Tennesseans receive the best consumer protection."
The agreed final judgment 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.
The State's complaint and agreed final judgment may be viewed by going online to www.tn.gov/attorneygeneral and clicking on "Filings of Interest."
Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at (615) 741-4737 or toll-free in Tennessee at (800) 342-8385.