OKLAHOMA CITY – A few Oklahomans helped shed light on a major pharmaceutical company’s practices that may have harmed patients and defrauded the state out of almost $1 million.
Wyeth has agreed to pay nearly half a billion dollars in settlement money for unlawfully marketing one of its drugs. The drug in question was approved by FDA to be used only by kidney transplant patients.
Officials announced Tuesday a multi-million dollar resolution from lawsuits, including two filed in Oklahoma, against a pharmaceutical company accused of marketing a drug for unapproved uses.
The drug is called Rapamune. It keeps the body from rejecting a new kidney.
The Justice Department announced that Wyeth Pharmaceuticals, Inc. has agreed to pay $490.9 million to resolve the case.
Tuesday, U.S. Attorney for the Western District of Oklahoma, Sanford Coats, said Wyeth Pharmaceuticals was marketing Rapamune for uses not approved by the FDA, such as for liver and lung transplants.
Coats said Wyeth trained its sales force to promote the non-approved uses, and even paid bonuses to incentivize sales. Two former sales reps, including one in the Oklahoma City area, were listed as whistle blowers in the lawsuit.
Oklahoma Medicaid will be reimbursed $700,000 as part of this $490.9 million settlement.
“This was a systemic, corporate effort to seek profit over safety,” Coats said Tuesday at a press conference. “Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.”
Pfizer, Inc., which owns Wyeth Pharmaceuticals, Inc., responded in a statement, saying “Pfizer was not a subject or target of this matter, and cooperated fully with the government from the time it learned of this investigation in october 2009.
U.S. Attorney Sanford Coats said at a press conference today that the conduct in question, which occurred prior to Pfizer’s acquisition of Wyeth, was “inherited” by the company.”
Officials at the Integris Transplant Program say the lawsuit has nothing to do with the effectiveness of Rapamune. They urge anyone who has been prescribed the drug to keep taking it.
Rapamune is an immunosuppressive drug that prevents the body’s immune system from rejecting a transplanted organ.
“The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses,” Sanford Coats said, U.S. Attorney for the Western District of Oklahoma. “Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales. This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.”
Officials said about 92 percent of the doctors who prescribed this drug for the unapproved uses were contacted by the sales reps.
The settlement resolves two federal lawsuits in western Oklahoma under the whistleblower provisions of the False Claims Act, which allow private citizens to bring actions against a company on behalf of the government and share in any recovery.
The lawsuits were originally filed by former Rapamune sales representatives.
Wyeth has agreed to pay a criminal fine and forfeiture of $233.5 million. Oklahoma will receive $700,000 from the settlement, which will go toward a Medicaid fund.
Authorities said Medicaid should not have covered those prescriptions because the use was not approved for those cases by the FDA in the first place.
Health officials said they cannot prove any patients died because of the drug’s unapproved use.