The "Rule" That Isn't

Mark Senak of FleishmanHillard and author of the EyeOnFDA blog presented a webinar on Thursday about the social media guidances. Here's a link to his blog post about it. The presentation itself is not yet available, but during the talk Mark mentioned that he would be posting a recording of the session later. I'll try to let you know when it is available.

During the Q&A of the session, someone asked about the "one click rule."

My experience is that whenever I speak about how FDA applies advertising and promotional regulation to the Internet, someone asks the same question, so I thought it would be useful to have a blog post available that I can simply send people to.

The other thing I find in speaking engagements is that when I poll the audience after I receive the question about the "one click rule" the results are invariably the same. One third of the audience doesn't know what the "one click rule" is, one third is convinced that it's true, and one third knows that the rule is not a rule (hence the scare quotes throughout this post).

So, first, what is this alleged "rule"?

The idea behind the "rule" is that it is OK to present benefit information online so long as risk information is presented within one click (i.e., via a hyperlink) of the benefit information.

Anyone who has been closely following the FDA's discussion of Internet advertising knows that this is false. Indeed, it's safe to say that if someone claims to know anything about FDA regulation of Internet promotion and then endorses the "one click rule," then in fact, that person doesn't know anything about FDA regulation of Internet promotion of prescription products.

Based on John Driscoll's excellent book on FDA ad/promo regulations, I believe the first FDA enforcement action for Internet promotion was in 1998. In that action, the FDA stated that "the link to the full prescribing information alone is insufficient to meet the requirements...that advertisements contain fair balance."

It's been a while since anyone could say that a link could meet the fair balance requirement.

But I can hear at least one person objecting that this isn't fair because the FDA in 1998 was objecting to presenting a link to the PI as a means to meeting the fair balance requirement, but the "one click rule" actually applies to a dedicated link to risk information, not the PI, since the PI contains both benefit AND risk information.

Interestingly, so far as I am aware, the first time FDA discussed having a link to a page dedicated to risk information (and not merely a link to the PI or to the product website more generally) is in the most recent guidance on presenting risk information in space-limited contexts.*

And in that guidance, FDA makes clear that even if a product sponsor includes a link to a page that is dedicated to the presentation of risk information that the link itself will not suffice to meet the fair balance requirement. FDA states that even in the most limited contexts, "[r]isk information should be presented together with benefit information within each individual" communication. In addition, the FDA recommends including a link to a web page that is dedicated to presenting the risk information.

The "one click rule" never did exist, but where did it come from, and why is it one of those zombie ideas that never seems to die?

The origin of such ideas is always difficult to trace. Driscoll cites the FTC disclosure requirements, while Mary Sullivan of Boehringer Ingelheim, presented a talk in 2010 that traced the origin to a comment by FTC on FDA policy.

I don't know that I'm able to add any further light on the subject of its origins, but one important thing to notice about both of these proposed origin stories is that the context is important. In neither case was FDA endorsing the idea. Instead, in the former case, the FTC was adopting its own policy about certain required disclosures, and if there's one word that marketers of prescription products should avoid when discussing the fair balance requirement, it's "disclosure." The fair balance requirement is not a requirement to disclose certain information because that word generally implies that you can meet your obligation by simply making certain information available without regard to its prominence, readability, or likelihood of being perceived and understood by the reader.

In contrast, the fair balance requirement can only be met by making certain that the risks associated with the product are presented with a comparable prominence to the benefit information, and no one could argue that information that is one click away could possibly be as prominent as the information that is in the message itself.

One reason I suspect this idea keeps recurring is that there are other requirements of prescription product promotion that the FDA does think can be met by providing a link. For example, the adequate provision requirement to make the product label with directions for use available is frequently met via the use of links, and in its space-limited guidance, FDA made clear that sponsors can meet the requirements to include a dosage form, quantitative ingredient information via a link to that information rather than providing it in each message.

Perhaps in the pending guidance on the use of hyperlinks, FDA will clarify its rationale for which information must be presented within a message and which information it is permissible to make available via hyperlinks.

Until then (and unfortunately probably long after that), you can just bookmark this blog post and send it to anyone who asks about the "one click rule."

* BTW, if anyone is aware of an enforcement action that does cite a link to a web page dedicated to the risk information, please leave the citation in the comments. Every citation I have been able to find, including of course, the 2009 letters on Google paid search advertising include either links to the PI or just to generic pages on the product website with risk information, but not to a web page dedicated solely to the presentation of risk information.

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