It’s been over two years since the FDA – in March, 2014 Draft Guidelines and then in its June 2014 “grant” of an industry-submitted citizen’s petition – promised to review its restrictions on so-called “off-label promotion” by regulated drug and medical device manufacturers. We were skeptical at the time that all we would get is “still more agency bobbing and weaving.”
Then two years with zilch – save more Agency First Amendment losses in off-label promotion cases. Then industry gets sufficiently frustrated by FDA inaction on off-label communication issues that it starts to take matters into its own hands.
So, a month later, we finally hear from the FDA again.
Finally, some action?
Don’t bet on it.
On August 31, 2016, a notice appeared in the Federal Register entitled “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments.”
Wonderful. More talk, and the FDA kicks the can further down the road. Once again the Agency refuses to recognizes the constitutional bind in which it finds itself. Indeed, the term “First Amendment” doesn’t appear anywhere – not even once – in the notice. Nor does the FDA so much as utter the phrase “off-label.” Except for citations, the FDA uniformly uses the more pejorative term “unapproved.”
If not the First Amendment, then, what do we have?