I've been out and about lately and have gotten behind on posting, but before addressing any backlog I have to refer to today's news:
A 2-1 majority of ta panel of the 2nd Circuit Court of Appeals (Manhattan) dismissed the conviction of a drug rep for off-label marketing on the grounds that he was simply exercising his free speech rights. The government will appeal, first to the entire Appeals court, and next to the Supreme Court if that is unsuccessful.
If you have been following our numerous posts about criminal settlements of big drug companies with the Feds in recent years--most recent example: http://brodyhooked.blogspot.com/2012/11/lets-do-it-again-latest-federal.html
--then you know that when the Feds manage to catch the companies doing shady marketing, almost always the regulation that's violated has to do with off-label marketing. We have long had the apparent paradox that while physicians can legally prescribe any drug for whatever purpose, despite what the official FDA-approved label says, companies can only legally market the drug for approved uses. This has become the principal tool by which the regulators can rein in the excesses of the industry. So if this ruling were to stand, the entire landscape of drug regulation in the USD would shift radically.
As the one dissenting judge stated the obvious, the ruling undermines the entire system of FDA regulation, since if companies can freely market drugs for off-label uses, they have no reason to go to the FDA to seek approval for any use except the most minimal required to get the drug onto the market at all. That means no need to submit any data to show that the drug is safe and effective for its various recommended uses.
As somebody concerned about ethics and logic I can say what I think of this ruling, quite apart from how it stands as a bit of legal reasoning based on case law and precedent. The logic part comes in when we ask how drug reps are trained by the companies and assigned to their jobs. Last I heard, the companies spend a lot of time and money to assure that their reps don't speak freely. They are trained to be consistent, reliable mouthpieces for the industry marketing message. Now, if a drug rep had been fired by industry for telling docs that a drug made by his company was unsafe or ineffective, and he sued to keep his job, and the court had ruled that he should keep his job because the company decision violated his free speech rights, then I might believe that the court was perhaps really serious about applying the doctrine of free speech to the relationship between drug rep and doctor. As it stands, to put what the drug rep did in this case by telling a doc (apparently one wearing a wire as a Federal informant) about off-label uses of the drug under the category of "free speech" is simply a bad joke.