Rapamune Off-Label Marketing Allegations

In February 2010, federal prosecutors opened an investigation into promotional efforts by Wyeth – which is now under the umbrella of Pfizer, following their merge in late 2009 – relating to its transplant drug, Rapamune (sirolimus). Rapamune is a “immunosuppressive agent indicated for the prophylaxis of organ rejection in patients … receiving renal transplants.” In other words, the drug is meant to help the body accept a kidney transplant.

In May, two former Wyeth hospital sales representatives, Marlene Sandler and Scott Paris, filed a whistleblower lawsuit against Wyeth in federal court in the Eastern District of Pennsylvania. The suit alleges that Wyeth illegally promoted Rapamune – which is indicated only for kidney transplants – for treatment in patients recovering from a variety of other transplant types, including heart, lung, liver, and pancreas.

Now, Congress has joined in the investigation, and Rep. Edolphus Towns (D-NY), Chairman of the House Committee on Government Oversight and Reform, is decrying the allegations in the whistleblower suit that Wyeth’s off-label tactics were targeted at African Americans. In Rep. Towns’ letter to Pfizer CEO, Jeffrey Kindler, he has requested that the company turn over a variety of information and documents related to Rapamune and Wyeth’s promotional tactics. Although the letter requested production of these materials to the House Committee by the close of business on Monday, June 28, 2010, there is still no word as to whether Pfizer has complied, or if it has complied, what the materials show.