Attorney General Jim Hood and 41 Other State Attorneys General Reach a $35 Million Consumer Settlement with Pfizer Concerning Rapamune®

August 8, 2014

Attorney General Jim Hood joins 41 other Attorneys General in announcing a $35 million settlement with Pfizer Inc. over alleged consumer protection violations concerning the immunosuppressive drug Rapamune.

Mississippi’s portion of the settlement is $532,675.94.  Pfizer Inc., as parent of Wyeth Pharmaceuticals Inc., agrees to be bound by the judgment, to resolve allegations that Wyeth unlawfully promoted Rapamune, currently approved by the FDA as prophylactic for organ rejection after kidney transplant surgery.

“The Complaint and Consent Judgment we filed allege that our state consumer protection laws were violated by misrepresentation of the uses and benefits of Rapamune,” said Attorney General Hood.

Included in the allegations are misrepresentations 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.

The Consent 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.

Oregon and Texas led the Executive Committee, which also includes Attorneys General from California, Florida, Illinois, Maryland, New York, North Carolina, and Pennsylvania.

Also participating in the settlement are Alabama, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee, Utah, Virginia, Washington.

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