Pennsylvania is set to receive more than $1.3 million from a $35 million settlement reached on Wednesday with pharmaceutical giant Pfizer, Inc.
The original complaint filed by the New York Attorney General's office accused Wyeth Pharmaceuticals Inc., a subsidiary which Pfizer acquired in 2009, of using deceptive marketing practices to promote Rapamune, a drug that has been FDA-approved to only prevent organ rejection after a kidney transplant.
According to the complaint, Wyeth allegedly promoted off-label marketing practices and encouraged the drug for non-approved uses, such as following a heart, liver or lung transplant or in other drug combinations.
Pennsylvania and 41 other states joined the suit and will each receive a portion of the settlement. Attorney General Kathleen Kane announced that Pennsylvania will receive $1,367,403.76 from the agreement. In 2013, Pfizer entered into a $409 million settlement with the U.S. Department of Justice over the marketing claims. As part of both deals, neither Pfizer or Wyeth were forced to admit any wrongdoing.
The consent judgment also requires Pfizer to ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any Pfizer product.
Specifically, Pfizer shall not, among other things:
- Make 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 if 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;
- 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.