Pfizer Takes $491M Charge To Settle Federal Investigation Of Rapamune Promotion

by Tara Arick on November 3, 2012 · 0 comments

in martindale.com

- From LexisNexis® Mealey’s™ Daily Legal News.

Pfizer Inc. on Nov. 2 said in a quarterly financial report that it has taken a $ 491 million charge for an agreement in principle to settle a federal investigation into its promotions of its anti-rejection drug Rapamune.

Pfizer has previously disclosed that the U.S. Attorney’s Office for the Western District of Oklahoma is conducting a civil and criminal investigation into subsidiary Wyeth’s promotional practices for Rapamune.

In 2010, the U.S. Justice Department intervened in a False Claims Act lawsuit filed in the Eastern District of Pennsylvania, which alleges off-label promotion of Rapamune. Later that year, the case was transferred to the Western District of Oklahoma (United States of America, ex rel. Marlene Sandler, et al. v. Wyeth Pharmaceuticals, Inc., et al., No. 5:10-1317, W.D. Okla.).

Relators’ Claims

Relators Marlene Sandler and Scott Paris allege that Wyeth, now owned by Pfizer, marketed Rapamune for off-label uses and paid kickbacks to doctors to promote and prescribe the drug.

Rapamune was approved to prevent rejection of kidney transplant. The whistle-blowers allege that Wyeth marketed Rapamune for other organ transplants, despite side effects.

Filings in the qui tam case were sealed in June.

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