The Department of Justice has issued a subpoena to biotech company InterMune regarding the promotion and marketing of Actimmune.
The subpoena requires the Brisbane, Calif.-based company to
provide information about the drug in addition to promotional and marketing materials. An InterMune spokeswoman said the firm would cooperate with the request.
Actimmune is a genetically engineered version of a naturally occurring protein that stimulates the immune system and is marketed for treatment of two rare but life-threatening congenital diseases in children -- chronic granulomatous disease and severe, malignant osteoporosis.
But "substantially all" of Actimmune revenues "are derived
from physicians' prescriptions for off-label use," the company said in its latest quarterly filing.
In March 2004, a former InterMune sales rep, Joan Gallagher,
filed a wrongful termination lawsuit against her former employer in the U.S. District Court for the Eastern
District of Pennsylvania. Gallagher alleged InterMune required the sales force to market Actimmune for unapproved indications and structured compensation systems to advance the allegedly unlawful marketing. InterMune has denied the allegations and is seeking the dismissal of the case, according to the company's spokeswoman.