FDA's One-click Study

At the beginning of November, FDA announced its intention to conduct a study looking at the so-called "one-click rule." As readers of this blog know, I've termed this, "The 'Rule' That Isn't."

The basic idea behind any version of the one-click rule is that companies can meet their fair balance requirement (21 CFR 202.1(e)(5)(ii)) by including a hyperlink to the risk information, rather than by providing the risk information itself in the original communication. As I've written about previously, this idea has had significant allure for marketers of prescription products but there has never been any indication from the FDA that it was open to it...until now.

I have been working with a few different clients preparing comments on the study proposal outlined by the FDA. Those will be posted to the docket and available for public view at a later date.

In this post, I wanted to take a step back and look at what this study means (and what it doesn't mean) for the immediate and future use of space-limited contexts by prescription product manufacturers and FDA guidance about this issue.

In 1998, FDA took its first enforcement action for Internet marketing. At the time, the FDA noted that "the link to the full prescribing information alone is insufficient to meet the requirements...that advertisements contain fair balance."

This began an 18-year history of the FDA making clear that it did not acknowledge a one-click "rule." This position was further solidified via FDA's 2014 guidance on space-limited contexts (the so-called "Twitter Guidance") that directly addressed the use of Twitter and search engine marketing formats that explicitly limit the number of characters. In that guidance, FDA asserted, "Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication." This is as explicit a rejection of any version of a one-click rule as FDA could possibly have made.

Just one sentence earlier in the guidance, FDA further asserted that, "If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion)."

Combined, these two statements established a framework that FDA was explicitly acknowledging could not be used by some manufacturers of prescription products for making claims about the benefits of their products. The consequences of this framework is that in certain contexts only products not subject to FDA's fair balance requirement would be able to provide benefit information about their products.

Of course, "benefit" information includes any suggestion of the product's indication. In practice, this means that prescription products manufacturers are frequently prevented from letting people know that their product(s) are possible treatment options for them; and that FDA's official position, as expressed in the 2014 guidance, is that this is fine.

Many people objected to this aspect of the draft guidance (see, for example, the comments from PhRMA), and that resulted in a brief movement to include a version of the one-click rule in the 21st Century Cures Act.

In that context, FDA's openness to studying these issues is a major step forward. Rather than simply assuming without any evidence that the public is harmed by companies following some version of a one-click rule, FDA is actually studying the issue.

This positive development is balanced, however, with the study design itself. In the proposed study, FDA is comparing a format that makes use of a one-click rule with a format that follows the recommendations from the 2014 guidance. One problem with this study design is that it is comparing a format that the FDA has acknowledged is not available to all product manufacturers because of the nature of their specific indications and risks. Indeed, I'm not aware of a single company that has attempted to use the format FDA demonstrated in that guidance for Google search or a Twitter ad.*

In addition, although FDA's willingness to study this topic is refreshing, the study announcement coming late in 2016 would seem to indicate that the status quo will remain for several years. It has been more than a year since FDA has released any new or updated guidance related to advertising and promotion (the last one was a minor revision in August of 2015), and the existing FDA guidance on space-constrained contexts has some glaring issues, independent of the position on one-click.

Taking a generous view of FDA's speed in fielding this research, it would be difficult to imagine that the final study results would be available before the end of 2017. FDA absolutely takes the work of its research team into account in developing guidance, including the ad-promo research. That probably means that the earliest we would see any update to the 2014 guidance would be 2018.

That's four years after FDA released the draft guidance and nine years after the 2009 hearings. FDA can't be expected to provide guidance that keeps up with the pace of technological change. Indeed, I think that's a virtue rather than a drawback to FDA's approach. It's better to have guidance that lags slightly behind innovation rather than wasting time developing guidance on topics that prove to be mere flashes in the pan. Consider the wasted effort if FDA had developed a guidance dedicated to Sidewiki after its 2009 hearings.

This, however, is a very different situation. FDA's enforcement activity related to its rejection of any version of the one-click rule has spanned nearly 20 years. Throughout that time, marketers of prescription products who want to inform the public about how they can help have been hindered in the ability to make that information available in the platforms that people are showing they prefer. And only now is FDA announcing its intention to see whether that position has any basis in actual experience. 

* If anyone is aware of such an ad, please share it in the comments or via the contact form in the right rail.

One-click Legislation Lives On

On Friday, the House of Representatives passed the 21st Century Cures Act. An early draft of this legislation included a provision about social media that would have essentially written the one click rule into law.

This video presents the exchange between Dr. Janet Woodcock, who leads the Center for Drug Evaluation and Research at FDA, and Representative Billy Long of Missouri about that provision (exchange begins at 2:35:35 mark).

Unfortunately, that provision didn't make it into the final version that passed last week; however, one click isn't finished just yet. As I discussed in a new column for DTC Perspectives and another recent article in The Medicine Maker, this is far from finished.

Representative Billy Long of Missouri has sponsored this item as a standalone piece of legislation. In addition, copy and paste is one of the easiest technologies to master, and once draft language is available, there is a tendency for it to get picked up in other efforts that aren't always directly related.

It's worth noting in that regard that discussions have kicked off in earnest about the renewal of the Prescription Drug User Fee Act (PDUFA). The last time this legislation came up for renewal was 2012, and that renewal included a mandate that FDA release guidance about using social media, leading directly to a new national holiday.

At the moment, one click doesn't have a Democratic cosponsor, but I know from conversations with Rep. Long's office that they consider this a bipartisan issue and expect to find a Democrat to sign on. Certainly, from my perspective, there is nothing partisan about this topic. People are adopting social media channels, and there is an incentive for industry to provide truthful, balanced, FDA-regulated information to them. But FDA's current interpretation of the regulations makes it difficult (and frequently impossible) for industry to provide that information.

It is worth pausing to consider the implications of industry's forced absence from these conversations. Of all of the information that is available about prescription treatments, the ONLY information over which the FDA has jurisdiction is promotional communication by industry. So, the only people who are required by the FDA to provide accurate, balanced information are currently being hindered in their efforts to provide that FDA-regulated information.

And as Aristotle (and Gary Larson) taught us, nature abhors a vacuum. Absent industry's involvement in these platforms, others, who don't face the same restrictions, will participate. Some of that information will be accurate; some of it won't. None if it will be subjected to the same high standards required by the FDA for industry's communications.

New 21st Century Cures Act Removes Social Media Provision

The House Energy and Commerce Committee have released a new draft version of the 21st Century Cures Act, which would significantly change how the FDA operates.

An earlier version of this bill included a provision that would basically have written a version of the one-click rule into law and required FDA to

"review each regulation and guidance that applies to the dissemination by means of the Internet (including social media platforms and character-limited applications) of information about medical products" and "treat hyperlinked information ... as if the information" were part of the initial communication.

In essence, Congress was mandating that FDA permit some version of the one-click rule, and revise or withdraw all guidances and regulations that prevented them from doing so.

This language has been completely removed from the latest draft legislation. I haven't seen any coverage of why this provision was dropped, and I was never able to determine where the initial language came from.

So, for now, the idea that legislation will drastically alter the landscape for using social media has taken a set back. But once draft legislative language is out there, it tends to crop up again and again.

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.