Connecticut Joins National Settlement Resolving
Allegations of Off-label Marketing of Rapamune
Attorney General George Jepsen, Chief State’s Attorney Kevin T. Kane and Department of Social Services (DSS) Commissioner Roderick L. Bremby today announced that Connecticut has joined with other states and the federal government in a settlement with Wyeth Pharmaceuticals, Inc. to resolve allegations of off-label marketing of the immunosuppressive drug, Rapamune.
Rapamune is a Food and Drug Administration (FDA) approved kidney transplant drug, which is prescribed to prevent the body from rejecting a transplanted donor organ. An investigation resulted from complaints filed in federal court alleging that Wyeth knowingly promoted the sale and use of Rapamune for use in connection with solid organ transplants patients other than kidney transplant patients, which were not medically accepted indications and were not covered by Medicaid. The complaints also alleged that Wyeth promoted the drug’s sale and use in treatment regimens that had not been approved by the FDA.
Wyeth agreed to pay the states and the federal government $297,400,000 in civil damages and penalties to resolve civil allegations of Rapamune’s off-label marketing. Over $60 million of this amount will go to state Medicaid programs, while the remaining funds will be designated for other federal health care programs affected by the company’s conduct. Connecticut’s Medical Assistance Program is eligible for a combined state and federal reimbursement of $645,168, of which $297,520 will go to the state.
Additionally, Connecticut will receive $127,778 for state-specific prescription drug programs administered by DSS.
“This conduct not only potentially puts critical patients at risk, we also believe it constituted a fraudulent claim against our Medicaid program,” said Attorney General Jepsen. “We take allegations of fraud or abuse very seriously, and this sort of conduct simply will not be tolerated. I’m proud of my office’s continued partnership with the Chief State’s Attorney and the Department of Social Services in these matters.”
Chief State's Attorney Kane commended the Medicaid Fraud Control Unit in the Office of the Chief State's Attorney, the Office of the Attorney General and the Department of Social Services for their continued efforts to recover scarce public resources and protect the integrity of the Medicaid program.
“While Connecticut’s participation in this national settlement brings a measure of relief to taxpayers, nearly $300 million in damages and penalties paid nationally by this pharmaceutical company will hopefully serve as a deterrent to other such conduct,” DSS Commissioner Bremby said. “I appreciate the role of the Attorney General’s Office and Chief State’s Attorney’s Office in working with DSS to help offset Medicaid costs.”
In addition to the civil damages and penalties, Wyeth has pled guilty in federal court to violations of the U.S. Food, Drug and Cosmetic Act and has agreed to pay $233,600,000 in criminal fines and forfeitures.
In late 2009, Pfizer Inc. acquired Wyeth. The off-label marketing, and the conduct to which Wyeth pled guilty, occurred prior to Pfizer’s acquisition. Pfizer cooperated fully with the federal government and the states in this investigation.
Anyone with knowledge of suspected fraud or abuse in the health care system is asked to contact the Medicaid Fraud Control Unit in the Office of the Chief State's Attorney at 860-258-5986 or by email at email@example.com
; the Attorney General's Antitrust and Government Program Fraud Department at 860-808-5040 or by email at firstname.lastname@example.org
.; or the DSS fraud reporting hotline at 1-800-842-2155 or by email at email@example.com
Office of the Attorney General:
Jaclyn M. Falkowski
Office of the Chief State's Attorney:
Department of Social Services: