Photo of Bexis

While we’re still sitting around waiting for the Second Circuit to decide Caronia, we though we’d pass along a new article on the First Amendment and the FDA’s restrictions on off-label use.  It’s by Kyle Thompson, a law student at BU, and it’s titled “The Changing Landscape of the Commercial Speech Doctrine and FDA Advertising Regulation: Off-Label Marketing in the Wake of Sorrell v. IMS.”  We got it through SSRN for free, although we did have to register. We hope we’re not overstepping our bounds somehow, but here’s a link to the article.

We found it, frankly, because it cited a couple of Bexis’ articles on the subject.  But you can put that aside, since what he wrote is pretty old.  The Thompson piece also cites and to some degree synthesizes a flood of more recent scholarship (see article at fn.7) that’s been written since Bexis left writing law review articles to law professors and decided to take up blogging instead (to the relief of both professors and bloggers).

Anyway, we don’t want to spoil your reading enjoyment by giving everything away, so we’ll just hit the highlights:  (1) an interesting discussion (using Botox as an example) of the government’s campaign to monetize the FDA’s questionable prohibition truthful promotion of off-label use; (2) a good, detailed discussion of the Sorrell case, which introduced academe to the off-label use issue; (3) some critical analysis of non-speech alternatives to the FDA’s current regime; and what was probably the most interesting to us (4) an analysis of what the more general opinion − Citizens United v. Federal Election Commission, 130 S. Ct. 876 (2010) − could bring to the table. That’s the good stuff.

Conversely, we were disappointed in one aspect, or non-aspect, of the Thompson article.  We were hoping, especially in the Citizens United context, for a discussion of fully-protected scientific speech, as opposed to just promotion of off-label use as commercial speech.  We see scientific speech as the closest analogy to the political speech at issue in Citizens United, although we’re still somewhat skeptical of exactly how relevant Citizens United is to the entire off-label use issue.

Anyway, if you’re into the First Amendment’s impact on off-label use promotional restrictions, you’ll probably enjoy the new article.