REPORT FROM THE DCCA – HONOLULU – The Hawaii Office of Consumer Protection (OCP) today announced that Hawaii and 41 other states have reached a $35 million settlement today with Pfizer Inc., which, as parent of Wyeth Pharmaceuticals Inc., agreed 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 judgment filed in Hawaii state court allege that Wyeth violated Hawaii’s consumer protection laws by misrepresenting the uses and benefits of Rapamune, including making representations related to:
· unapproved use of Rapamune following an organ transplant other than a kidney transplant;
· unapproved protocol of converting patients to Rapamune after initially receiving a different immunosuppressive drug; and
· using Rapamune in unapproved drug combinations.
“OCP has taken action in multiple cases over the past few years to protect Hawaii consumers from unscrupulous pharmaceutical marketing practices. Today’s complaint and judgment creates important protections for consumers by putting an end to the marketing of Rapamune based on unsubstantiated claims and stops questionable practices promoting it for unapproved off-label uses,” OCP’s Executive Director Bruce Kim said. “OCP will continue to look out for pharmaceutical companies that put profits over the interests of consumers.”
Under today’s judgment Pfizer must ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any Pfizer product. Specifically, Pfizer may 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 Guidance 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.
Lisa Tong, a senior staff attorney at OCP, represented the state in this case.
An office of the State of Hawaii Department of Commerce and Consumer Affairs, OCP educates and protects consumers from unlawful acts or practices by companies, which may cause harm to consumers. For more information about services, contact the OCP at (808) 586-2636.