FRANKFORT, Ky. (Aug. 7, 2014) — Attorney General Jack Conway has announced a $35 million settlement with Pfizer Inc, who as parent of Wyeth Pharmaceuticals Inc. agrees to be bound by the judgment. Kentucky will receive $606,391.35 as its share of the settlement.
The settlement resolves allegations that Wyeth unlawfully promoted Rapamune, an immunosuppressive drug currently approved by the FDA to counteract organ rejection after kidney transplant surgery. The judgment, filed today, alleges 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.
“I will continue to protect Kentuckians from drug companies that put profits over patients,” Conway said. “Marketing of pharmaceuticals that have not been approved based on sound evidence for a particular use can be a dangerous and even deadly practice.”
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:
- 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 increased 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.
- 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.
Kentucky participated in this settlement with 42 other states including Oregon, Texas, California, Florida, Illinois, Maryland, New York, North Carolina, Pennsylvania, Alabama, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Georgia, Hawaii, Indiana, Iowa, Kansas, 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.