Josh Bloom, Medical Progress Today "Off Label Advice for Doctors- The Appeals Court is Dead On"
Off-label drugs-- those used for indications other than what the drug was originally approved for-- have been used for many years. Most of us have probably benefited from this practice, but despite this, it has been illegal for a pharmaceutical sales rep to even mention a possible off-label use of any drug to doctors.
That changed Monday, when the Court of Appeals for the Second Circuit in Manhattan curtailed the FDA's authority to limit what sales reps are allowed to say to doctors about their company's drugs, throwing out the conviction of a sales rep who was found guilty of selling a narcolepsy drug for off-label indications. The court's argument was based on First Amendment rights, and although I don't really know or care about the constitutionality of this. I just know a good idea when I see one.
I'm sure the anti-pharmaceutical activists will be howling about this one for quite some time. I can already see the headlines: "Big Pharma Money Buys Corrupts Courts" or "A Legal Win for Pharma; A Loss for Us."
And of course, there will also be countless analyses about how the First Amendment was not designed to permit sales reps to "illegally push" drugs that have not been approved for a particular use upon doctors and their patients. But until now, this was the law...[Read more].