Pfizer Inc. has agreed to pay $35 million to a number of states across the country to settle claims by attorneys general that Wyeth Pharmaceuticals Inc. pushed Rapamune, an immunosuppressive drug used to prevent organ rejection after kidney transplants, for off-label uses including liver, heart and lung transplants. The New York-based drug giant has agreed, among other things, not to promote off-label uses for its drugs, not to make unsubstantiated claims about their efficacy — or compare its drugs to others’ in the absence of legitimate evidence — and not to influence the prescribing of Rapamune in hospitals or transplant centers. New York Attorney General Eric T. Schneiderman, whose staff led the multistate investigation, said in a statement:
Patients and consumers need to have confidence in the truthfulness of claims made to them by medical providers without having to worry about drug companies manipulating the doctor-patient relationship.
Colorado Attorney General John W. Suthers, in a separate statement, pointed out that Wyeth had been marketing the varied uses of the drug despite several U.S. Food and Drug Administration (FDA) “black box” warnings related to liver, lung and other patients. Attorney General Suthers’ office, in a statement, said further:
Despite Rapamune’s limited FDA approval for use in kidney (renal) transplant only, and despite black box warnings relating to use in lung and liver transplants, Wyeth promoted Rapamune off-label for nonrenal transplants.
Wyeth misrepresented the range of uses for Rapamune through an orchestrated campaign of promotional talks by Wyeth-retained doctors, the attorneys general said. Prosecutors also alleged Wyeth pushed Rapamune for conversion use — switching a patient from another drug to Rapamune — which was also unapproved, and pushed the drug in unapproved combinations with other medications.
In January 2009 Pfizer agreed to pay $2.3 billion to settle allegations that it improperly marketed its anti-inflammatory drug Bextra. That same year Pfizer bought Wyeth for $68 billion. Pfizer said in a statement that the conduct occurred prior to its acquisition of Wyeth and that the company voluntarily disclosed the conduct to investigators in 2012.
In addition to New York and Colorado, 38 states — Alabama, Arizona, Arkansas, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, South Dakota, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin — as well as the District of Columbia – will benefit from this settlement.
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