Here’s a thought that was brought to my attention by the folks over at @FDALawyers during the Digital Pharma East conference last week: as long as the FDA does not release guidelines on how to approach social media, they remain powerless to enforce it.
It doesn’t seem right, does it? Well, hear me out.
Apparently (again, thanks @FDALawyers) the Supreme Court has ruled multiple times that if a regulating agency does not provide clear guidance, it cannot impose penalties. The case cited was the FCC vs. Fox and ABC for various infractions on the broadcasting code. It turns out that the FCC wasn’t able to make its penalties stick because it had not issued clear enough guidance to the broadcasters about what was in, and out, of bounds. In the court’s words:
(a) The fundamental principle that laws regulating persons or entities must give fair notice of what conduct is required or proscribed, see, e.g., Connally v. General Constr. Co., 269 U. S. 385, 391, is essential to the protections provided by the Fifth Amendment’s Due Process Clause, see United States v. Williams, 553 U. S. 285, 304, which requires the invalidation of impermissibly vague laws.
Now, at first blush this would seem to indicate that the FDA can’t issue letters against companies that violate regulations that are unacceptably vague. The FDA non-guidance on social media would certainly constitute regulations that were vague.
However, what is an FDA letter really? I know that marketers in pharmaceutical companies are deathly afraid of them, but what happens after a company is issued a letter? They reply with their plan to fix the problem. Then the FDA tells them whether that fix is adequate.
And that’s pretty much it.
So, as long as the company doesn’t go out of its way to flout the process or ignore the FDA’s requests most of the time the problem just goes away.
When looking at the Supreme Court’s issue with the FCC the penalties were a lot heavier than a letter, they were financial. I’m actually left thinking that the Supreme Court would consider the FDA letters as “fair notice”. The only way that would be invalidated is if the company could show that an FDA letter is a form of financial punishment … which should be possible based on the amount of work it puts the companies through.
In any event, it is possible we’re better off without written guidelines regarding social media for pharmaceutical marketing, regardless of what so many pundits say.