Let's talk about paid search!

For many people, Google serves as the home page of the Internet, so it seems fitting that Google paid search ads and FDA's 2009 enforcement activity started the five-year path to the social media guidances FDA released this year.

I'm currently drafting an article about this topic for the September issue of RAPS Regulatory Focus, which is dedicated to the topic of advertising and promotional regulation, and I just accepted an invitation to speak about the same topic at a conference in Philadelphia on Friday, September 12.

CBI is holding the one-day event, and the agenda is packed with experts and friends, including both industry and consultants. It's certain to be a great event, and I hope you'll join us.

EyeOnFDA Webinar Available Now

I mentioned in a previous post that Mark Senak of FleishmanHillard conducted a webinar about the FDA's social media guidance, and I promised to post a link when he made the recording available.

Well, it's now available here.

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.

FDA Still Not Ready to Tackle Mobile Promotion

Updated to correct error of publishing an incomplete sentence and a misspelling.

On Thursday, FDA held a webinar about its recent social media guidances. Despite technical difficulties that prevented many (including me) from attending the webinar, FDA did field questions from some of the attendees, and late on Friday afternoon, they posted that Q&A along with the slides from the presentation portion of the event.

In reviewing the Q&A about the space-limited presentation of risk information guidance, one exchange stood out:
Q1. Does this draft guidance apply to space limitations imposed by mobile devices?
A1This draft guidance does not address technology-specific layout features that may result in product promotion presentations that differ depending on the technology used to view them (e.g., mobile devices, desktop computer monitors, and tablets). The scope of this draft guidance is specific to Internet/social media platforms that impose character space limitations.

While the guidance itself clearly specifies that its scope is limited to social media platforms and paid search with character-count limitations*, it is disappointing to see the exchange. Perhaps it was the nature of the question that resulted in this specific answer, but one would certainly like to know how widely applicable the principles from this guidance are to mobile devices in particular because many of the issues that apply to presentation of risk information in limited character counts also apply to presentation in limited space.

In addition, though, this Q&A further emphasizes one of my concerns about the guidance. It concerns itself solely with the content of each individual Tweet** and completely ignores the surrounding context and nature of Twitter interactions. That larger context is part of what I have begun fleshing out via a previous post about a different Twitter proposal. There is far more going on when a person views a Tweet than just the 140 characters in the Tweet itself, and I believe that FDA is inappropriately limiting both its evaluation of what can make a Tweet compliant (or non-compliant) and its understanding of the actual uses of Twitter and other social media platforms.

Social media hosts public conversations, and just as you would not expect every single sentence uttered to include the complete conversation, you should not necessarily expect every Tweet to include everything needed to achieve a compliant communication.

Further adding to the difficulty is that just as FDA is finally providing guidance to address some of the most pressing issues in social media, we're seeing massive shifts in the consumption of social media itself with an increasing amount of social media interaction happening via mobile devices. So much so that some people have taken to referring to the combined fields as "somo" or "moso" to underline how much the line between social media and mobile has blurred.

* "This draft guidance also does not address responsive web design or other technology-specific layout features that may result in product promotion presentations that differ depending on the technology used to view them (e.g., desktop computer monitors, mobile devices, tablets)." (page 2)

** It's worth noting that people have been referring to this guidance informally as the Twitter guidance, and by refusing to discuss how to apply its principles beyond Twitter and Google, that moniker seems even more appropriate. For years, FDA declaimed its intention to not provide guidance that was limited to any specific platform(s) because of how rapidly the platforms evolved, and yet, ironically, it seems as if FDA is now intentionally doing exactly that.

FDA Webinar Slides & Q&A Now Available

FDA's social media webinar from Thursday had some technical difficulties.

After acknowledging the problems, the FDA then made the slides from the presentation available very rapidly. Late on Friday afternoon, they also posted a transcript of the Q&A.

Here are the links:

Still feeling the need to chat?

The highly anticipated FDA social media webinar happened today. Apparently, some people were able to attend; though based on my Twitter feed, it seemed as if more people were having problems than actually getting in.

I was one of those who experienced difficulties. I logged in at 1:45 for the 2 p.m. start because FDA had warned that it was already booked to max capacity. I received a message that the webinar hadn't begun and would start at 2 p.m.

2 p.m. came and no webinar, then 2:05. Then, I started scrambling trying to log in in a different browser, reloading the page, even restarted my computer.

Then (of course), I started checking Twitter and saw that other people were experiencing the same problems.

I received an email from FDA with a new link that also didn't work.

@US_FDA Tweeted out a message acknowledging the problems and promising to post slides later. BTW, they're here.

From what I can tell based on the commentary on Twitter, there was very little new ground covered. The consensus of the Twitter discussion was that FDA largely read directly from the guidances themselves (the slides seem to back up that view) and only chose questions to answer that were already answered in the guidance themselves.

As for the guidances themselves, I would suggest that there are still many unanswered questions, including this and this.

For an overview of the guidances, I'd recommend this one.

And given all of the technical difficulties and limited Q&A, I'm renewing my call for a Twitter chat about the guidances. If CDRH can do it, I'm not sure why the rest of the agency can't.

Another Google Search Letter

Just 10 days after issuing its space-limited guidance that included a significant discussion of Google search ads, the Office of Prescription Drug Promotion (OPDP) issued a new letter to Gilead for a a paid search ad.

Here's the violative ad as posted by the FDA:

The infractions don't differ substantially from those cited in the landmark 2009 set of 14 letters for inappropriate paid search campaigns that in many ways began the current emphasis on the unique characteristics of space-limited contexts.

In those 2009 letters, multiple products were cited for three infractions:
1. Failure to use the required established name
2. Omission of risk information
3. Inadequate communication of indication

In addition, one product was cited for overstatement of efficacy.

The new letter includes again the omission of risk information and failure to use the required established name; however, this time the FDA cited a lack of adequate directions for use and a failure to submit under form 2253.

The failure to submit under 2253 is well understood.

The lack of adequate directions for use points to the inclusion of the word "prevention." Viread is currently approved for the treatment but not the prevention of hepatitis B.

As I mentioned previously, I'm working on a new article for the September issue of Regulatory Focus that will revisit Google paid search and pull together everything we have learned from the 2009 enforcement action, subsequent statements from the FDA, and the new draft guidance. This enforcement action definitely adds another piece to that puzzle.

FDA Social Media Guidance Webinar

I have been trying to get the FDA to host a Twitter chat, having suggested it on Twitter, and then followed up on this blog.

This morning @US_FDA announced that there will be a social media webinar later this week. There isn't much information about the webinar at the registration page, but the confirmation email includes the following description:
The purpose of this webinar is to provide an introduction and overview of FDA’s three recently issued social media draft guidances Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,  Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Subject-matter experts will also be available to answer questions regarding the draft guidances and provide further explanation of key concepts.

I hope you'll join the webinar as I'm sure we're all anxious to have this Q&A on the three social media guidances this year.