Florida Part of $35 Million Pfizer Rapamune Settlement By Tod Aronovitz | 08/13/14 | 0 Comment

The office of Florida Attorney General Pam Bondi announced that the state of Florida, along with 41 other states and the District of Columbia, reached a $35 million settlement with Pfizer Inc. to resolve allegations about the unlawful promotion of Wyeth Pharmaceutical’s immunosuppressive drug Rapamune®. Florida’s share of the settlement is more than $1.7 million.

Wyeth, which is owned by Pfizer, allegedly violated state consumer protection laws in regards to Rapamune, a drug approved to help prevent the rejection of new kidneys in kidney transplant patients.

According to the AG’s announcement about the Pfizer Rapamune settlement, the complaint and consent judgment accuses Wyeth of misrepresenting the uses and benefits of Rapamune including: its unapproved use after an organ transplant other than a kidney transplant; unapproved protocols of changing patients over to Rapamune after they initially receive different immunosuppressive drugs; and using Rapamune in unapproved drug combinations.

As a result, Pfizer is required to ensure that marketing and promotional practices of its pharmaceutical drugs, including Rapamune, comply with the law. 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 that 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.

“My office served on the Executive Committee of the attorneys general that obtained this consent judgment because consumers deserve clear and truthful information when making important decisions about the medications critical to their treatment,” Attorney General Pam Bondi said.

Oregon and Texas led the Executive Committee, which also included attorneys general from the states of: 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, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee, Utah, Virginia, Washington, and Wisconsin.

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