The Maryland Attorney General, along with Attorney Generals from 41 other states (including the District of Colombia) have reached a $35 million settlement with Wyeth Pharmaceuticals, Inc. regarding the promotion of the drug Rapamune. Wyeth is owned by Pfizer which agrees to be bound by the settlement although the alleged illegal activity took place prior to Pfizer’s acquisition of Wyeth in 2009.
Rapamune is an immunosuppressive medicine approved by the US Food and Drug Administration to prevent the body from rejecting a kidney after kidney transplant surgery. The state Attorney Generals allege that Wyeth improperly promoted Rapamune for use in lung and other organ transplants. A whistleblower lawsuit on the same issue alleged that Wyeth provided kickbacks in the forms of grants, donations and other monies to hospitals and doctors that used the drug for other transplant purposes. Moreover, the lawsuit alleges that Wyeth targeted these illegal uses in the African-American community. The complaint and consent judgment filed by the participating states alleges that Wyeth violated consumer protection laws by making representations related to: (1) the unapproved use of Rapamune following an organ transplant; (2) the unapproved protocol of converting patients to Rapamune after they had initially received a different immunosuppressive drug; and (3) using Rapamune in unapproved drug combinations.
The judgment 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 or 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
– 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
– 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.
This is the second settlement involving Rapamune for Wyeth. In 2013, many states joined the federal government in a $491 million settlement to resolve civil and criminal allegations about Wyeth’s promotion of Rapamune in violation of the Food, Drug and Cosmetic Act. Some believe that Wyeth is avoiding criminal liability by paying off the government agencies that are supposed to police them and that the fines paid are a small amount compared to the size of the company. Regardless, the settlement monies are a boost to Maryland’s bottom line as it will receive a portion of the $35 million settlement.