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Attorney General J.B. Van Hollen and 41 Other State Attorneys General Reach a $35 Million Consumer Settlement with Pfizer and Wyeth Concerning the Immunosuppressive Drug Rapamune
 

MADISON — Attorney General J.B. Van Hollen, along with the attorneys general of 41 other states and the District of Columbia, has reached a $35 million settlement with Pfizer Inc. and Wyeth Pharmaceuticals Inc. to resolve allegations that Wyeth Pharmaceuticals Inc. unlawfully promoted Rapamune, an immunosuppressive drug currently approved by the FDA to prevent organ rejection after kidney transplant surgery.  Pfizer, as the parent company of Wyeth Pharmaceuticals Inc., agrees to be bound by the terms of the proposed Final Judgment.  Under the settlement, Wisconsin shall receive $677,491.66. 

 

The Complaint filed today alleges that Wyeth violated state consumer protection laws by making representations that were untrue, deceptive or misleading as to the uses, benefits, or qualities of Rapamune, including promoting Rapamune for off-label use (a use not approved by the FDA): (1) following an organ transplant other than a kidney transplant; (2) as part of a conversion protocol to switch a patient to Rapamune after initially receiving a different immunosuppressive drug; and (3) after kidney transplant in combination with drugs other than indicated in the product’s FDA-approved labeling.   

 

The Proposed Final Judgment, which was submitted today for the Court’s consideration, requires Pfizer (and its subsidiary, Wyeth) to ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any other 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. 

 

Also participating in the settlement are Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, 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, and Washington.

 

The State was represented by Assistant Attorney General Lara Sutherlin.

 

Copies of the Complaint and Proposed Consent Judgment submitted to the Court for its consideration are available at the following links:

Proposed Consent Judgment

Summons and Complaint