DOJ ENTERS ANOTHER OFF-LABEL SETTLEMENT

The Department of Justice (DOJ) has entered into another multimillion-dollar, off-label promotion settlement, which sources say reflects an enforcement priority for the federal government.

InterMune agreed to pay more than $36 million for off-label promotion of its drug Actimmune to treat idiopathic pulmonary fibrosis, or lung scarring, the DOJ announced Oct. 26. Off-label promotion involves marketing drugs for uses not approved by the FDA.

The government prosecuted InterMune for knowingly causing the submission of false and fraudulent Medicare and Medicaid claims for the drug. "It is vital to public health and safety that pharmaceutical companies are deterred from improperly marketing their drugs to doctors and patients to treat illnesses that these drugs are not approved to treat," Assistant Attorney General Peter Keisler said in a statement. "Today's settlement sends a clear message to the pharmaceutical industry that the Justice Department will not tolerate these deceptive and illegal marketing practices."

Industry observers have warned that the federal government is increasing its focus on off-label promotion, with numerous enforcement actions likely in the near future. The government recently entered into a $435-million settlement with a subsidiary of Schering-Plough for off-label promotion.

That action led Michael Loucks, first assistant U.S. attorney for the District of Massachusetts, to conclude that preventing off-label promotion is "clearly a priority of this administration and the Justice Department." There is currently a "pharmaceutical industry wave" of enforcement occurring, he added.

InterMune's President and CEO Dan Welch commented in an Oct. 26 financial earnings call that the company is "happy" to have the matter behind it.