Pfizer to Pay $35 Million to 42 States and Limit Off-Label Use and Promotion of the Immunosuppressive Drug Rapamune®
ATLANTA, GA – The Governor’s Office of Consumer Protection, along with the Georgia Attorney General and Attorneys General from 41 other states, have reached a $35 million settlement with Pfizer Inc., who as parent of Wyeth Pharmaceuticals Inc. agrees to be bound by the judgment, to resolve allegations that Wyeth unlawfully promoted Rapamune, an immunosuppressive drug currently approved by the FDA as 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, including making representations 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.
“It is vital that consumers be able to rely upon accurate representations of products that are being used to treat a medical condition, and that off-label uses and their promotion be curtailed,” says John Sours, Administrator of the Governor’s Office of Consumer Protection. “We are very pleased with this outcome.”
The Consent Judgment requires Pfizer to ensure for long periods into the future 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.
Georgia’s share of this settlement is $899,011.88.
“This settlement holds Wyeth Pharmaceuticals accountable for their deceptive marketing practice of promoting a drug for uses not approved by the Food and Drug Administration,” said Attorney General Sam Olens. “Consumers should feel confident that they can make important medical decisions based on accurate information.”
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, 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.
For more information, contact Shawn Conroy, Governor’s Office of Consumer Protection, at 404-656-3790.