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5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations


The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media. The first was entitled, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices. The second was entitled, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devices, which is the focus of this post.

While not as clear or concise as their other previous guidance releases, there are 5 key things digital marketers need to be aware of, some of which potentially muddying the waters more then originally planned.

1. Brands may present product claims within character–limited setting, but must include several elements to be considered compliant.

If and when a brand or product chooses to put claim information inside of a tweet, the claim must contain several elements, including:

  • The product and generic name
  • Appropriate balance for the claim being made
  • A direct link to a page containing more complete discussion of the associated risks of the product

The example used by the FDA is for a fictitious product, NoFocus, with the structure of the tweet illuminating the requirements.

NoFocus (rememberzineHCL) for mild to moderate memory loss; may cause seizures in patients with a seizure disorder

When presenting balance to a claim, the brand or product does not need to present the full risk statement, but instead is required to communicate, “the most serious risks associated with the product.” Read More…

Are Meta Tags a Regulatory Time Bomb?

Your branded pharma site is non-compliant. Yes, yours.

Paying attention yet?

As pharma marketers, we operate in a world governed by strict rules. As digital pharma marketers, those strict rules can often be ambiguous, poorly-defined, or simply absent, requiring us to interpret vague requirements and/or extrapolate from other (presumably) relevant precedents. (Yeah, I know, it’s almost exactly like having a girlfriend.)

Which brings me back to your

What’s to worry about, you say? Everything’s ship-shape, buttoned-up, right? On-label messaging, appropriate fair balance, all content submitted and approved by the FDA. Looks like everyone else’s.

Well, perhaps there is one aspect of your branded product site that you’ve overlooked. One that is routinely ignored as it seems so tucked away and safe from scrutiny. But one that is on the FDA’s radar and which might be the source of some serious compliance headaches one day soon. Could it be that deep down within the HTML code of your website there exists a regulatory time bomb?

Read More…

Applying Some Sanity to a Regulatory Debate

Okay…today’s post is a bit of a rant, but I think it’ll include some practical, rationale advice that will help you too. As you can tell by the featured image for this post, I find myself out of ideas on how to explain my point in a calm, bullet-pointed way, so I’m going with the rant approach. I’d like to thank a number of you for both adding clarity to my thoughts and for being the very inspiration behind this post (you each know who you are).

What am I so annoyed at?


Not the political ideology…the approach to marketing and specifically legal and regulatory concerns. To be sure, I’ve been one of the biggest defenders of the legal and regulatory teams at various companies. It’s not an easy job. You’ve got people like me telling you that you’re crazy and bashing their skulls against your walls when you won’t let them do something we we’d like. But at the same time, you save us from ourselves sometimes. As one of my favorite regulatory people once said, “I’m not telling you that you can’t do it, DDMAC [i.e., the FDA] is telling you that you can’t do it.” Substitute your own industry’s watchdog group in that quote if you’d like.

That somehow managed to get me off the ledge a few times and made me redirect my ire to more appropriate targets. However, after working with many, many companies over the past couple of years, I’ve realized one thing: it isn’t always DDMAC after all. Certainly it is sometimes, but other times, perhaps more times, it’s us. We’re not really mad that the FDA is preventing us from doing something, we’re mad that our own company won’t. Again, many of these rules exist to protect the company and make a lot of sense. I get that and I’m not advocating for anarchy, but I am advocating for a bit of common sense (perhaps I should have used a picture of Thomas Paine’s essay instead of the Sanity picture…nah).

The one “rule” that is making me crazy lately deals with the concept and interpretation of “sponsorship.” Allow me to explain what I mean by this. This might be something like when a company pays to have their content included on a website in something like a special information section. WebMD has a number of these. The regulatory challenge is that since the company is paying for the placement of this content, even though they don’t control the site in any other way (e.g., WebMD), the company is, of course, still responsible for the content itself. That is, they can’t include wildly off-label or inaccurate information simply because it’s not on their own website (here’s an example of one of these pages). Got that…makes total sense.

Here’s where I get annoyed…someone along the way has taken this regulation WAY too far. It seems that everything is treated as a “sponsorship” and what is in the control of the company and what it is liable for has been absurdly expanded. It’s no longer just sponsored “sections” or pages, it’s now ads as well. Allow me to demonstrate.

Rather than have a sponsored section on WebMD, you place a banner ad on WebMD. Okay. No problem, right? Wrong.

The new regulatory concern these days is figuring out what page the ad is placed on and what content surrounds it. Similarly, for the sponsored page, what other content, but that is not controlled by the company, is included on the page? The rationale?

Here’s an almost direct quote that I heard last week: “If we placed and paid to have something on the site, then we’re responsible for whatever is around it even if we have no control whatsoever over what’s around it.”


I’ve heard this from five different companies in the past two weeks. It’s a trend.

It’s leading to some behavior I find odd and unnecessary. For example, one company has removed their Facebook page because they were concerned about the ads (that Facebook controls) being placed next to their page’s content. What? The rationale from the legal and regulatory teams is that the company is somehow responsible for the content of those ads and the ads could expand the product’s claims and….

I don’t know what came after that…my ears stopped working, but I think you can fill in the blanks. I understand not wanting to have your ad next to an article bashing your product. That’s another story. That’s not desirable certainly, but it’s also not a violation of any laws.

So, let’s look at this rationally. First, this phenomenon appears to be especially acute on any site that you could remotely categorize as “social media.” That is, the rules seem a bit more lax when we’re not talking about Facebook. Social media always seems to make people panic. This tends to create a few interesting double standards. We’ll come back to that in a minute.

First, I want to share a perfect analogy that explains why all of this is so crazy. It comes from Peter Pitts, a former Associate Commissioner at the FDA and current partner at PR firm, Porter Novelli. I’d encourage you to read his entire commentary found in this white paper, but here’s the part I loved:

“…what does “sponsored mean? Let’s do a brief thought experiment. Consider a televised PGA tour event. When a product logo for an erectile dysfunction medicine appears on the screen and the announcer intones, “This portion of the Masters is sponsored by DRUG NAME HERE,” nobody out there in the viewing audience takes that to mean the “sponsor” has chosen the speed of the greens, the height of the rough or the pairing of golfers in the tournament. But say “sponsored” on a social media site and watch the sparks fly at internal regulatory review.”

Question for all of you: does that one simple statement make all of this debate about what you are responsible for seem a bit ridiculous all of a sudden? It did for me. It points out a perfectly created double standard that keeps social media as a pariah and “traditional” channels on the whitelist. Allow me to elaborate.

First, from Peter’s analogy, it’s okay if we “sponsor” a sporting event (or Race for the Cure or a NASCAR) and it doesn’t matter what appears next to our sponsorship. We don’t control, as Peter said, the pairings of golfers. Everyone’s fine with that. No one would assume otherwise because assuming otherwise would be insane.

But there’s more…

We don’t worry about what commercial follows ours on TV or what the news story leads into our commercial during the evening news.

We don’t care what ads appear above or below ours or what results appear on the same page as our paid Google AdWords.

We don’t think about what billboard is next to ours or what buildings it is near.

We don’t agonize over which stories are printed next to our ads in a magazine.

We don’t fret about which ads show up next to (or as a pre-roll to) our YouTube videos or channels. For example, here’s one of J&J’s videos (see red boxes):

I didn’t even bother highlighting the “Promoted Video” right under AOL’s ad.

So, how come regulatory and legal folks seem to be fine when we’re talking about TV, billboards, print, YouTube, Google, and yet worry about Facebook and some other places?

The FDA has never (read that last word again) told anyone that they are responsible for content they don’t control. So, if you place an ad or sponsor a section of a website, you should only need to worry about what you can control. You can control the content of what you give to the website to publish. That’s it. Of course, if you actually control more than that, then you’ve got a different issue. But you don’t control what ads show up next to your page on Facebook, so you’re not responsible for worrying about whether or not they cause your content to be in violation (side note: Facebook can actually turn off those ads in some cases, contact me if you need help).

Some of you might be saying that there’s a distinction between placing an ad (like a banner) and having a sponsored section. No way. You create the content for both and you dictate where each appears. For the sponsored section, you know where it’s going to go on the third party site (e.g., where on WebMD). For banner ads, you should know every single place where they show up. If not, talk with your media buying agency and get that info from them now. In each case, you created the content and helped decide on the placement. What you don’t get to decide is everything else that appears around it. Not the search results next to your Google AdWords, not the billboard under yours, not the TV commercial that follows your…none of these. Since you don’t control this why do you feel responsible? Why do you think that the FDA is going to come down on you? Show me one example and I’ll leave you alone.

We call these “ghost rules” around our office and they only do one thing really well: kill good thinking and innovation.

Rant over…thanks.

Digital Alert and Reco: FDA Warns Novartis Over Facebook Sharing

[UPDATE, Sept. 29, 2010: Our recommendations and guidance have changed since we made this post. Check out this latest post for the update.]

Last week, the FDA issued a Warning Letter for the website for their drug, Tasigna. The main issue in the violation was content that was shared via social media. The Tasigna site had Facebook sharing buttons that, like other sites, automatically generate content for sharing. The content of this content is what the FDA cited. This content is drawn from META description tags on the website. These tags are invisible to visitors, but are used by search engines.

The FDA argues that the content in these META tags should include fair balance (risks, side effects, warnings, etc.) since they had the drug name and indication. The FDA did not have an issue with Facebook sharing in of itself, but rather the content that the site generates automatically, which cannot be changed by the user.

This is a potentially serious issue for all pharma marketers, but one that isn’t as bad as it seems on the surface. Several team members and I here at Bridge Worldwide prepared a response document that details the issues raised in the FDA Warning Letter and also our recommendations on how to deal with the issues FDA brings up in the letter.

You can download a copy of the document here:

(UPDATED: 9/29: Please download our updated recommendations here: Digital Alert-Bridge Worldwide-Social Sharing in Regulated Industries (1298 downloads)

We welcome your comments and please feel free to share with your colleagues. As always, if you find it useful, please send out a tweet or Like this post so that others get a chance to see it too.

Some other good commentaries on this issue can be found here:

FDA demonstrates their ignorance of social media with letter to Novartis — Rich Meyer

Digitas Health Facebook Regulatory Alert — Digitas Health

Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget – John Mack