Ohio Attorney General Mike DeWine has announced that Ohio and 41 other attorneys general have reached a $35 million settlement to resolve allegations that Wyeth Pharmaceuticals Inc. unlawfully promoted Rapamune, a drug approved for use by kidney transplant patients. Pfizer Inc., the parent company of Wyeth, agrees to be bound by the settlement.
Ohio will receive $984,812 as part of the settlement.
“Promoting pharmaceutical drugs for unapproved purposes is not only potentially dangerous, it’s also a violation of consumer protection laws,” Attorney General DeWine said. “Investigators found that Wyeth promoted Rapamune for use by lung and other organ transplant patients, which is not approved by the FDA.”
Rapamune is currently approved by the U.S. Food and Drug Administration (FDA) to prevent the body from rejecting an organ after kidney transplant surgery.
The attorneys general allege that Wyeth violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, relating to: (1) unapproved use following an organ transplant other than a kidney transplant; (2) unapproved protocol of converting patients to Rapamune after they first received a different immunosuppressive drug; and (3) use in unapproved drug combinations.
The proposed settlement, which must be approved by the court, 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 effectiveness 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.
In Ohio, a complaint was filed and a proposed judgment order was submitted today to the Franklin County Common Pleas Court.
Participating in the settlement are the attorneys general of Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
In 2013, ADeWine announced that Ohio had joined with other states and the federal government in a separate $491 million settlement to resolve civil and criminal allegations about Wyeth’s unlawful promotion of Rapamune in violation of the Food, Drug, and Cosmetic Act. That settlement resulted in more than $2.5 million for Ohio.