When is off-label marketing ok?

Is it ok to market a drug off-label? The answer is NO and YES. NO — For a pharmaceutical, the answer is a definite no. For example, Elan Pharmaceuticals recently pleaded guilty to off-label marketing of its epilepsy drug Zonegran, and was sentenced to pay a criminal fine of $97 million and forfeit $3.6 million in substituted … Continue reading

Pain lozenges and off-label marketing

So, what do pain lozenges and off-label marketing have in common? The answer is Cephalon’s Fentora — which “is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain”. The problem, according to the US … Continue reading