In the past, we have reported about the liabilities that can arise for drug companies in U.S. Courts when they attempt to market drugs for unapproved off-label uses. In an interesting turn of events, Swiss pharmaceutical companies Novartis and Roche have recently been fined a total of $250 million in an Italian Court for exactly the opposite, promoting a drug that has been approved for a specific treatment over the unapproved off-label use of an alternate drug.
As reported in the New York Times, Novartis and Roche were found guilty of collusion by the Italian Government for promoting the use of the drug Lucentis over Avastin for the treatment of certain eye problems. According to the allegations, the companies did this in order to benefit from the higher profit raised by selling Lucentis, a more expensive drug (both drugs are sold by these two companies), raising concerns that Lucentis could be prohibitively expensive for some patients and therefore hamper their treatment. In fact, however, Lucentis is an approved treatment for the eye conditions at issue, while Avastin is a cancer drug that has never been approved under Italian and European law for the off-label use of treating these same eye conditions. The companies’ defense therefore was that they were not acting in order to benefit financially, but were simply complying with the regulatory requirement that they not market drugs for unapproved off-label uses. Interestingly, this defense was not successful in the Italian court.
Since pharmaceuticals are a global market, this ruling raises a peculiar dilemma for pharmaceutical companies navigating the promotion and sales of drugs that have multiple on and off label uses in various parts of the world. It also raises some bigger questions about the role of the courts and regulating agencies in overseeing the drug industry, in particular whether it is better to have a treatment withheld until it is proven that it is safe and effective, or better to have that treatment reach patients more quickly and affordably in the hopes that it will mitigate their pain and suffering? These are not easy questions to answer, and the answers may differ depending on the cultural norms and economic condition of the regional market, and companies must be sensitive to and aware of these variations. This holding also serves as a reminder to manufacturers of any internationally distributed product that risk management is not necessarily a black and white endeavor that ends with compliance with any one set of regulatory standards, but rather that risk management and business conduct may need to be adjusted to account for different policies and priorities in different jurisdictions.