Thought-provoking Legal News -- Part II


In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit ruled on December 3, 2012, that the Federal Food, Drug and Cosmetic Act’s misbranding provisions do not prohibit or criminalize truthful speech that promotes the lawful, off-label use of FDA-approved prescription drugs.

The decision overturn the prior conviction of a pharmaceutical sales representative for off-label promotion on the basis that the sales representatives behavior was protected under his First Amendment rights to free speech.  The ruling has the potential to severely undercut one of the central pillars of the federal government’s enforcement program relating to the marketing and use of FDA-regulated products.  It is difficult to imagine how the FDA will be able to continue to fully protect the American public, if those with a direct interest in