Given the Government’s dogged pursuit of the pharmaceutical industry for engaging in off-label promotion, and the billions of dollars the industry has forked over in recent years for False Claims Act “violations,” should federal prosecutors be worried that the off-label gravy train may be about to be de-railed by the First Amendment?  You bet.

The Stakes: No other relatively untested and unchallenged legal theory has ever generated more money for any litigant (public or private) than the Government’s theory on the illegality of off-label promotion. Over the course of the last decade, the Government has raked in about $13 billion in civil and criminal settlements – including $1.4 billion from Eli Lilly (Zyprexa) and $2.3 billion from Pfizer (Bextra) in 2009.  In just the last few weeks, we have learned that the Government will get $950 million from Merck (Vioxx), $1.5 billion from Abbot Labs (Depakote) and $3 billion from GlaxoSmithKline (Avandia). These settlements have all been predicated on the interesting notion that, while it is perfectly legal and proper for physicians to prescribe drugs for non-FDA approved (i.e., off-label) uses, it is criminal for the makers of those drugs to talk to those same physicians about those same off-label uses.

So far, the Government has either cavalierly dismissed arguments that the FDA’s off-label rules violate free speech rights, or has deftly maneuvered around them, as when it forced Allergan to dismiss its First Amendment based lawsuit as a condition of settling (for $600 million) a large, costly investigation.  Now, things look like they are about to change.  [Read more...]