|August 6, 2014
Contact: Whitney Ray
Phone: (850) 245-0150
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TALLAHASSEE, Fla.—Attorney General Pam Bondi and 41 other state attorneys general today reached a $35 million settlement with Pfizer Inc, the parent company of Wyeth Pharmaceuticals Inc., resolving allegations that Wyeth unlawfully promoted Rapamune, a drug given to patients to help prevent rejection of kidney transplants. The complaint and consent judgment filed today allege that Wyeth violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, including 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 different immunosuppressive drugs; and using Rapamune in unapproved drug combinations. Florida’s share of the settlement is more than $1.7 million.
“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,” stated Attorney General Pam Bondi.
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:
- ˇ Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive regarding any Pfizer product;
ˇ 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;
ˇ Promote any Pfizer product for off-label uses;
ˇ 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;
ˇ 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;
ˇ 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
ˇ 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 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.