|TRENTON – Acting Attorney General John J. Hoffman announced today that New Jersey will receive approximately $843,000 as a result of its participation in a multi-state civil settlement resolving allegations that Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc., unlawfully promoted its immunosuppressive drug Rapamune for uses not approved by the federal Food and Drug Administration (FDA).
Rapamune is only approved by the FDA for use as a prophylactic to prevent organ rejection following kidney transplant surgery. According to Hoffman, the overall, $35 million multi-state settlement resolves allegations that Wyeth violated consumer protection laws by, among other things, promoting Rapamune for use in other kinds of organ transplant patients. The settlement involves a total of 41 states and the District of Columbia.
A Complaint and Consent Judgment filed by the participating states 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 they had initially received a different immunosuppressive drug; (3) using Rapamune in unapproved drug combinations.
“Marketing drugs for unapproved uses is wholly inappropriate. New Jersey citizens have a right to expect more, and our consumer protection laws exist to ensure they get it,” said Acting Attorney General Hoffman. “Through our own efforts, and through collaborative effort with other states where appropriate, we are committed to identifying unlawful and potentially harmful business practices, and to holding those who engage in such conduct accountable.”
The Consent Judgment filed today requires Pfizer to ensure that its marketing and other business 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 or non-FDA-approved uses;
Utilize financial incentives to encourage the sale of Pfizer products for off-label uses;
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.
As an approved usage, Rapamune is given to suppress patient immune systems following a kidney transplant operation. The drug is applied, along with a second immunosuppressive drug called cyclosporine, and with corticosteroids, to prevent the body from rejecting the new kidney. Wyeth was acquired in late 2009 by Pfizer, Inc. However, the alleged off-label marketing of Rapamune that was the focus of the multi-state investigation took place prior to Pfizer’s acquisition of Wyeth.
Deputy Attorney General Natalie Serock, assigned to the Division of Law’s Consumer Fraud Prosecution section, handled the Wyeth/Pfizer matter on behalf of the State.