Thoughts on Global Medical Affairs
QuickNote: Off Label Promotion Ruled OK by US District Court
December 4, 2012Posted by on
In a ruling with huge potential impact on MA as well as commercial functions, the Court of Appeals for the Second Circuit in Manhattan has overturned a conviction of a salesperson who was promoting the off-label use of a product! This 2-1 ruling goes against years of court rulings stating that pharma does not have the right to promote off-label. In fact, in the past month GSK has been fined $3 billion for off-label promotion and J&J fined $181 million for off label promotion.
Clearly, new legal ground is being broken here. BUT, if urge caution. This is one ruling that contradicts years of previous rulings. It may serve as grounds for kicking this up to the Supreme Court, but until clear legal direction is given I would not be changing any policies.