UPDATE: DOJ Tries To Intervene In 'Off-Label' Case Against Pfizer

The U.S. Justice Department is trying to take the lead in a lawsuit accusing Pfizer Inc.'s (PFE) Wyeth unit of improperly promoting an organ-transplant drug for unauthorized uses and paying illegal kickbacks to doctors.

The lawsuit was filed by two former Wyeth sales representatives who were responsible for promoting Rapamune, an immunosuppressant used to prevent the body's rejection of transplanted kidneys. New York-based Pfizer, the world's biggest drug maker by sales, gained the rights to Rapamune with its purchase of Wyeth last year.

In a motion filed in federal court in Philadelphia Tuesday, the U.S. Attorney's Office for the Eastern District of Pennsylvania asked the judge for permission to take over the case, saying it had "good cause to intervene."

The lawsuit, first filed confidentially in 2005, alleges that Wyeth promoted Rapamune for off-label uses, or those not consistent with the prescribing label approved by the U.S. Food and Drug Administration. The suit alleges Wyeth promoted the drug for use in lung-transplant patients, for instance.

Drug companies are prohibited from actively promoting off-label uses, although doctors have the discretion to prescribe drugs in such a manner.

The lawsuit also alleges Wyeth violated laws banning kickbacks by providing cash and other incentives to induce doctors to promote and prescribe Rapamune, including for off-label uses.

The alleged off-label promotion caused false reimbursement claims to be submitted to government health programs, the lawsuit said. The drug costs between $8,000 and $20,000 per patient annually, according to the lawsuit. Rapamune generated $376 million in sales for 2008, the last full year reported by Wyeth.

The lawsuit also alleged that Wyeth promoted the drug for use in African American patients even though they are considered high-risk patients and there was limited clinical data to support such use.

"Our experience is generally that the government gets involved in a case where they find some merit in some or all of the [plaintiff's] claims, and we applaud the government's decision to intervene," said Reuben Guttman, an attorney for the former Wyeth sales reps.

Pfizer said in a written statement it's cooperating with the government in the matter, and that the company is committed to providing information to doctors about Rapamune that's consistent with the prescribing label. The company also said the drug "was never contraindicated for African-American patients or other high risk populations." Pfizer said the FDA in 2007 authorized the inclusion of additional dosing information in Rapamune's label for its use in high immunologic risk patients, after Wyeth conducted a post-marketing study.

In June, U.S. Rep. Edolphus Towns, head of the House Committee on Oversight and Government Reform, launched an investigation into the allegations that Wyeth promoted Rapamune off-label and targeted African Americans.

The Rapamune case is the latest in a series of off-label promotion cases pursued by the government throughout the drug industry. Pfizer last year paid a record $2.3 billion to settle government probes of allegations that it engaged in off-label promotion of the former pain drug Bextra and other products. AstraZeneca PLC (AZN) and Forest Laboratories Inc. (FRX) also have recently settled off-label investigations.

The lawsuit was filed under a federal law designed to encourage people with knowledge of suspected wrongdoing to blow the whistle, by giving such individuals a percentage of monetary settlements that may result from the lawsuit.

Pfizer previously disclosed that the U.S. Attorney's Office for the Western District of Oklahoma was conducting a criminal investigation of Wyeth's promotional practices for Rapamune.

-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com

(Brent Kendall contributed to this article.)

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