In this era of mega international pharmaceutical mergers, pending False Claims Act lawsuits oftentimes bubble to the surface at the closing table. Recently, as Teva Pharmaceuticals looked to wrap up its acquisition of Cephalon, Inc., it was revealed that the United States government was, once again, examining Cephalon’s marketing practices. Specifically, Cephalon disclosed that it had recently received a government subpoena requesting documents related to the alleged off-label promotions of its Treanda medication. While Trenda is only FDA approved for the treatment of chronic lymphocytic leukemia, allegations are swirling that Cephalon pushed the medication as a suitable first-line treatment of non-hodgkin’s lymphoma.
According to one news source, government investigators are especially interested in “uncompleted clinical studies that may be used to support off-label use,” and, in particular, “documents pertaining to a clinical study being conducted by to Mathias Rummel, who is the head of hematology at the University Hospital in Giessen, Germany.” This comes on the heels of recent announcements that the U.S. Justice Department is looking to expand its investigations into overseas pharmaceutical research studies, in order to uncover clinical trial fraud.
“Oftentimes enticed by lowered regulatory hurdles, pharmaceutical companies are increasingly flocking to foreign researchers to study the unapproved uses of their products,” said Nolan & Auerbach partner and former Taxpayers Against Fraud president Jeb White. “When beneficial preliminary data emerges from these studies, the results seep their way into paid speaker presentations and the promotional arsenals of pharmaceutical sales representatives. The end result is that off-label data is promoted to health care providers, outside the watchful eye of the U.S. Food & Drug Administration.”
Only time will tell if Cephalon was engaged in this international end run around the FDA. However, the message should be clear to the pharmaceutical industry that illegal off-label promotions, wherever their origin, will not be tolerated in the United States. Nolan & Auerbach, P.A. partner Ken Nolan wrote about Pharmaceutical Research Subcontractors in the October 2003 issue of Contract Pharma.
For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.