Attorney General Kathleen G. Kane announced today that her office and 41 other state attorneys general have reached a $35 million settlement with Pfizer Inc.
In the settlement, Pfizer, who is the parent company of Wyeth Pharmaceuticals Inc., agrees to resolve allegations that Wyeth unlawfully promoted Rapamune.
Attorney General Kane said that the off-label marketing case provides the Commonwealth of Pennsylvania with a payment of $1,367,403.76 along with substantial injunctive relief. The Pennsylvania Office of Attorney General was a member of the multi-state action’s executive committee.
Rapamune is an immunosuppressive drug currently approved by the United States Food and Drug Administration as a prophylactic for organ rejection after kidney transplant surgery.
The complaint and consent judgment filed today allege that Wyeth violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune. This included allegedly making representations related to:
- 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
- The use of Rapamune in unapproved drug combinations.
The consent judgment requires Pfizer to ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any Pfizer product.
Among other things, Pfizer shall not:
- Make 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 if 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;
- 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 executive committee was led by Oregon and Texas, which, in addition to Pennsylvania, also included the attorneys general from California, Florida, Illinois, Maryland, New York, and North Carolina.
State attorneys general also participating in the settlement include Alabama, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee, Utah, Virginia, Washington, and Wisconsin.
The agreement was filed in Commonwealth Court by Chief Deputy Attorney General Thomas M. Devlin and Deputy Attorney General Nicole L. VanOrder of the Health Care Section.