FRANKFORT, Ky. (July 31, 2013) — Kentucky, the federal government and other states will participate in the $491 million settlement of two lawsuits against drug companies Wyeth Pharmaceuticals, Inc. and Pfizer, Inc. over the illegal marketing of the prescription drug Rapamune, Attorney General Jack Conway announced Wednesday.
Rapamune was approved by the Food and Drug Administration (FDA) for use in kidney transplants to prevent the body from rejecting a donor organ following a transplant.
The civil and criminal claims against Wyeth were the result of qui tam actions filed in the United States District Courts for the Eastern District of Pennsylvania and the Western District of Oklahoma under the federal False Claims Act and various state false claims statutes. The complaints alleged that Wyeth, which Pfizer acquired in 2009, marketed Rapamune for “off-label” uses not approved by the FDA, including use in liver and non-kidney transplants. Wyeth also illegally marketed Rapamune despite a “Black Box” package warning required by the FDA advising against such use because of the risk of graft loss and death.
The complaints further alleged that Wyeth marketed Rapamune for use in combination with other immunosuppressive drugs used to prevent the rejection of transplanted organs. Again, the package label approved by the FDA stated that the use of other immunosuppressive drugs in combination with Rapamune had not been found to be safe and effective.
The Kentucky Medicaid program will receive $584,848.27 from the settlement, of which it will retain $158,298.83 after reimbursing the federal government for its share of the settlement proceeds.
As part of the settlement, Wyeth plead guilty to violating the federal Food, Drug and Cosmetic Act, and will pay $233.6 million in criminal fines and penalties.