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ePharma Rx: Did off-label promotion just become legal?

Did off-label promotion just become legal?



What happened? A summary

On Monday, a federal appeals court in New York threw out the conviction of a pharma sales rep for promoting off-label use of a prescription drug. The court found the sales rep’s First Amendment right to free speech had been violated. Judge Denny Chin wrote:
« In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”

The ruling essentially follows the notion that « The more information available to everyone, the better. If physicians can discuss alternative uses of drugs, others should be able to do the same.”

So far, not surprisingly, FDA has not commented on the ruling.


What does it mean?

What does this mean for FDA?

What does it mean for patients?

What does this mean for pharmaceutical companies today?


If any change is to come from this, I expect it to be slow. It’s definitely something to keep an eye on. And this is just one court’s decision. Future decisions for similar cases, as well as escalation to the Supreme Court, may further solidify the situation one way or the other.

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