Pfizer Faces Criminal Investigation Over Rapamune Marketing

Federal prosecutors have opened a criminal investigation into Wyeth’s promotions and marketing activities involving the organ transplant drug Rapamune.

Pfizer, which purchased Wyeth last year, announced in a regulatory filing on February 26 that it was under investigation by the U.S. Attorney’s office for the Western District of Oklahoma. Pfizer officials did not provide any further details on the potential allegations, and federal prosecutors declined to comment on ongoing investigations.

Rapamune (sirolimus) is an immunosuppressant that prevents the body from rejecting organs after transplant surgery. The drug generated $376 million in sales in 2008.

It is most often used in kidney transplants for hemolytic-uremic syndrome, which can reoccur in a transplanted kidney. However, the drug is also commonly prescribed off-label for liver transplants as well. It is illegal for drug companies to promote medications for off-label uses, even though doctors can prescribe approved medications for any purpose they feel is appropriate.

The new charges come after Pfizer agreed last year to pay $2.3 billion to settle charges that it illegally marketed the painkiller Bextra and other drugs. That settlement included the largest criminal fine in U.S. history, $1.195 billion. The fine was specifically for off-label promotion charges.

That Pfizer settlement followed a four-year investigation into the company brought about after whistleblower lawsuits were filed alleging that Pfizer was defrauding the government. The agreement was reached in September, including a corporate integrity statement in which Pfizer promised federal prosecutors that the company would toe the line on off-label promotion restrictions.

In June 2009, the FDA issued a warning to transplant doctors that Rapamune side effects could increase the risk of death in liver transplant patients after a study found that the chance of liver rejection was “significantly higher” for stable liver transplant patients who switched from a calcineurin inhibitor (CNI)-based immunosuppressive treatment to Rapamune.

The FDA already requires that Rapamune carry a “Black Box” warning advising against its use immediately after a liver transplant.