When is off-label promotion not off-label promotion? Well, as with so much in the world of FDA regulations -- it depends.
In this case it depends on the FDA's decision to relace ambiguity with a draft guidance on the matter. But the question remains, is this even within the agency's jurisdiction?
Of course, we can always depend on Henry Waxman (America's Oversighter-in-Chief) for a fair and balanced comment. Here's one sentence from his 11 page letter to the FDA on the leaked draft of the draft guidance:
"It would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs."
But Henry, what do you really think?
At the end of the day, shouldn't physicians have free and unfettered access to publicly available, peer-reviewed scientific information?
Oh yes, and then there's that First Amendment thing.
In this case it depends on the FDA's decision to relace ambiguity with a draft guidance on the matter. But the question remains, is this even within the agency's jurisdiction?
Of course, we can always depend on Henry Waxman (America's Oversighter-in-Chief) for a fair and balanced comment. Here's one sentence from his 11 page letter to the FDA on the leaked draft of the draft guidance:
"It would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs."
But Henry, what do you really think?
At the end of the day, shouldn't physicians have free and unfettered access to publicly available, peer-reviewed scientific information?
Oh yes, and then there's that First Amendment thing.
