The U.S. Department of Justice has joined a lawsuit filed by two whistleblowers who accuse Pfizer and its subsidiary Wyeth Pharmaceuticals of pressuring them to promote off-label uses of the drug Rapamune, The New York Times reports. The drug is used in kidney patients to prevent rejection of transplants.
Nineteen states, the Times reports, also joined the lawsuit, which was filed under the False Claims Act. Under the act, the government may chose to join cases brought by whistleblowers who report false claims against the government — in this case, that government-funded Medicare and Medicaid programs paid for illegal uses of a drug.
The whistleblowers, former employees of Wyeth, first sued in 2005, claiming they were encouraged to promote Rapamune for heart, lung, liver and pancreas transplants, even though the drug had approval from the Food and Drug Administration for use only in kidney transplants. Doctors can prescribe drugs for uses other than those approved by the FDA, but drug companies cannot promote those off-label uses.
The suit also accuses Wyeth of paying illegal kickbacks to doctors, The Wall Street Journal reports, as well as targeting two hospitals with largely black patients for off-label promotion of Rapamune. African-Americans have a higher risk of rejecting organs during transplant operations, according to the Times.
The federal government’s action comes a year after Pfizer agreed to pay the largest health care fraud fine in history, $2.3 billion, to settle claims that the company illegally marketed four drugs.
Pfizer noted in a statement that the whistleblower suit was filed four years before the company bought Wyeth, and a spokesman added that the company was cooperating with the government’s review of its subsidiary’s practices.
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So why did the FDA not put all of the worst case side effects allergic reactions
for the medications on the new labels? The FDA told me they reserve the rigth to NOT
put all side effects on the labels. It was announced in the final papers from DOJMA/HHS and the FNA, do we not have the right to get ALL of the information out there.
They are holding onto Lyrica for dear life. That drug can kill you, we need to know.
Please inform me how to get this information from the FDA. I think Coma, Catatonia, unresponsiveness, blindness are all very important side effects. We are talking about people who have had reactions to this medication and experienced these symptoms.
Can someone enlighten me?