Try as it might, the FDA just can’t seem to articulate sound regulatory policy relating to “promotion” (which still isn’t defined in any regulation) without running headlong into the wall of the First Amendment.  Recently, the FDA released, “for comment purposes only” two draft guidances relating to promotion on the internet. One of them is called “Guidance for Industry − Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  You can read that one here.  The other one, entitled “Guidance for Industry − Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” can be accessed here.  

Both draft guidances seek to regulate what regulated manufacturers can do to “promote” their products on their own websites.  Okay, we have no inherent problem with the Agency doing that.  FDA-regulated manufacturers are, after all, FDA regulated.

Unfortunately, the FDA never seems to be satisfied with regulating only those it is empowered to regulate.  Its bureaucratic empire builders always seem to overreach.  In these draft guidances, they do so by laying claim to authority over non-manufacturer websites that regulated manufacturers “influence.”  For example, in Interactive Promotional Media DG declares:  “A firm is responsible for product promotional communications on sites that are . . . influenced . . . by . . . the firm.”  Id. at 3.  What does “influence” mean?  It’s hard to say because the FDA’s discussion is somewhat tautological, but here is the Agency’s “guidance” on that point:

In determining whether a firm must submit promotional material about its product(s) to FDA, the Agency considers whether the firm . . . is influencing . . . the promotional activity or communication in whole or part.  Thus, a firm is responsible if it exerts influence over a site in any particular, even if the influence is limited in scope. For example, if the firm . . . has editorial, preview, or review privilege over the content provided, then it is responsible for that content.

Id. at 4.  Thus, “regardless of financial support, if a firm has any . . . influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.”  Id.

The guidance offered by the Correcting Misinformation DG suffers from similar Agency delusions of grandeur.  “A firm is responsible for communications that are . . . influenced . . . by, or on behalf of, the firm.” Correcting Misinformation at 3.

[I]f a firm . . . exerts . . . influence on product-specific content provided by a third party, to the extent that responsibility for the development of the content is imputable to the firm, the recommendations set forth in this guidance do not apply. Accordingly, as a general matter, the firm must comply with all applicable regulatory requirements.

Id. at 5.  Once more, with feeling − “a firm’s . . . influence over a product-related communication, even when generated by a third party, may result in the firm being responsible for the information.”  Id.

That’s a pretty darn broad – and thus chilling of speech – definition of “influence.”  We don’t think the FDA means to, but by its terms it could even apply to this blog.  All of our readers know that we have lots to say (121 posts) about off-label use.  Sometimes, we’re offering general observations.  Sometimes we discuss the topic in the context of a particular case, and thus a particular product. Well, we’re first and foremost lawyers.  That means that we owe our primary duty to our clients.  That also means that our clients have the power to “influence” us, as their representatives in pending litigation, either to blog or not blog about this or that decision or legal issue.  The statements on some of our posts, “This is by the [fill in blank] side of the blog, only,” are a reflection of that simple fact of life.

So, is a client informing us “please post about this” or “don’t post about that” an exercise of “influence” that triggers compliance obligations under these draft guidances with respect to anything posted on DDLaw?  We don’t think that’s what the FDA has in mind – we doubt it’s thought about legal blogs at all – but the overbroad description of “influence” found in these draft guidances could be read as encompassing “influence” exerted through the attorney/client relationship.  Thus, if literally interpreted, the “influence” statements in the draft guidances could theoretically reach as far as this blog and the clients of the lawyers who write for it.  Such regulatory statements, not cabined in any way by truth or falsity as is typical for the FDA, could be considered a First Amendment “chilling effect,” that is, if we were capable of being chilled.

It’s getting chilly out there.