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 Brand.com.
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?
Why Worry About Meta Tags?
I’m guessing that most of you are familiar with meta tags. But just in case, meta tags are snippets of HTML code in a given webpage that provide descriptive information about that page. Below are examples of three common Meta Tags and their formats:
<title>Your page title goes here</title>
Meta Description Tag:
<meta name=“description” content=”Your descriptive sentence or two goes here” />
Meta Keyword Tag:
<meta name=“keywords” content=“primary keyword, secondary keyword, tertiary keyword” />
(Note: Actually, the Title Tag above isn’t technically a meta tag, but I’ll treat it as such for this discussion.)
Most, if not all, pharma companies submit a website’s meta tags for internal Medical-Legal-Regulatory (MLR) review. MLR will typically look for potential problems such as broadening of indication, unsubstantiated superiority claims, or overstatement of efficacy. In my experience, however, MLR very rarely identifies a problem related to omission of risk (i.e., lack of fair balance)—even when a Title Tag or Meta Description Tag or some combination thereof result in making a claim about a product.
So why isn’t fair balance an issue when dealing with a page’s meta tags that make claims? One prevailing argument seems to go something like this…
- Meta tags are buried in the code of a webpage and are essentially “behind-the-scenes,” invisible to human audiences.
- Moreover, meta tags are written specifically for search spiders—not humans—to help search engines understand what a webpage offers in an effort to increase search engine visibility.
- And even if a third party were to take some or all of our meta tag content and republish it outside the context of our website, we can’t be held accountable because we a) did not create the copied version and b) we cannot control what others do with our information.
So how does this argument hold up?
First, let’s test the invisibility claim. It’s pretty easy to dispute, actually. Below are three ways that meta tags can become visible to human audiences:
- Browser—a page’s Title Tag is displayed to website visitors at the top of a browser’s chrome (i.e., the borders of a browser window) and within a browser’s application tabs. For Title Tags that include both the brand and the indication, however, fair balance is not an issue because on pharma branded product sites the ISI is always present within the page content itself.
- Social Media Sharing—some social media sharing tools, which enable users to share webpages within social media channels like Facebook and Twitter, use the page’s Title Tag and Meta Description Tag to create the piece of content that is shared. As we will see in a bit, this can get pharma companies into trouble, but thankfully there are now simple solutions.
- Organic Search Results—search engines like Google often (though not always) use Title Tags and Meta Description Tags to create their organic search results. For example, in the Lipitor.com example below, you can see that the Google organic search result is directly pulled from these tags:
<title>LIPITOR ® (atorvastatin calcium) | Safety Info | Official Site</title>
<meta name=”description” content=”Find information on cholesterol lowering medication and high cholesterol. Read about the risks and benefits of LIPITOR® (atorvastatin calcium).” />
It’s #3—the organic search result—that poses the real problem.
THE BIG QUESTION: Can the FDA hold Pfizer in violation for a lack of fair balance in the Google organic result above? It’s clearly making a claim, but the safety information is not presented along with the claim. Instead, it’s one click away. But hey, this is Google’s search result. Why is this Pfizer’s problem? Where Pfizer fits in is that in creating the organic result, Google grabbed content from the Lipitor.com’s meta tags, which Pfizer controls. Should Pfizer be worried?
Now let’s test the argument that meta tags are written for search engines, not humans. Well, all you need to do is look at the Lipitor.com meta tags above—or the meta tags on any other pharma site—and you’ll see why this argument won’t hold water. Pharma companies simply cannot deny that they write meta tags with the understanding that real people will read them. Moreover, times have changed. While in the past meta tags were used by some engines to evaluate Page Rank, these days meta tags have little to no impact on search engine visibility. Today, marketers use meta tags to improve user experience (displaying page titles within browsers) and to increase click-through rates (via descriptive, compelling organic search results), not to maximize search engine visibility.
The last component—the “non-accountability” argument—has the most legs, but it’s far from rock solid. The risk lies in the intent. It would be difficult for a pharma company to argue that it doesn’t understand how search engines work or that it doesn’t write meta tags with a full understanding of how search engines will use them.
What Does the FDA Say?
To date, the FDA has not issued any guidance, letters, or other communications which refer to content that search engines display within their organic search results. Moreover, to my knowledge, the FDA has not required pharma companies to submit website meta tags a part of required FDA filings. Not much to go on, right? But what can we learn from what the FDA has said and/or done in other situations?
There are three FDA actions that I believe are relevant here:
April 2009 – Death of the One-Click Rule in Paid Search Ads
By now you are surely familiar with the FDA’s infamous 14 warning letters, issued in April 2009, in which the FDA stated that providing the important safety information one click away was insufficient to meet fair balance requirements in paid search ads that make claims. Given the space constraints inherent in paid search ads, these letters forced pharmaceutical marketers to take one of two approaches when using paid search ads:
- Reminder Ads which include the brand name but do not mention the condition (note: the FDA has said Reminder Ads are not permitted for black box drugs)
- Help-Seeking Ads which include the condition but do not mention a brand name
July 2010 – Death of the One-Click Rule in Social Media Sharing
Just over a year later, Novartis received an FDA warning letter for the social media sharing widget on its Tasigna.com site. The site’s sharing tool was pulling content from the webpage’s meta tags to display as the content being shared, which in some cases resulted in content that made a claim. For example:
The warning letter cited several other problems—namely broadening of indication, unsubstantiated superiority claims/ overstatement of efficacy, and failure to submit—but the issue most pertinent to this discussion was the “omission of risk information” problem. Based on this letter, it is clear the FDA applies the fair balance principle to content shared outside the context of its website (at least via social media sharing tools) and that the “one-click rule” is not sufficient for compliance in these instances:
“We note that the shared content contains a hyperlink to various Tasigna product websites, which do contain risk information. However, the inclusion of such a hyperlink is insufficient to mitigate the misleading omission of risk information from these promotional materials.”
It’s interesting to note that the letter refers only to content that was shared via the social media sharing tool—there is no mention of content that appears in organic search results. Also, nowhere in the letter does the FDA mention meta tags or the source of the shared content—it focuses solely on the content that was shared and visible to the public which the pharma company controlled.
The good news for social media sharing is that new pharma-compliant sharing tools now exist that allow marketers to fully control the content that is shared independent of a website’s meta tags. These tools instead use a different type of tag called open graph protocol tags. In fact, shortly after the Novartis letter, Dose of Digital’s own Jonathan Richman worked with ShareThis to develop such a pharma-compliant version and wrote about this solution on this blog. But while FDA-compliant social media sharing is now easy to implement on websites, this warning letter raises concerns about organic search results, which are created from the same source content.
February 2012 – Letter to BioAnue Laboratories
BioAnue Laboratories received this warning letter because the FDA believed the company was promoting non-FDA-approved products as drugs. The reason I think this letter is relevant is because it’s the only warning letter I’ve seen so far that specifically mentions meta tags:
“The claims quoted above are supplemented by the metatags used to bring consumers to your web pages through Internet searches. Examples of some of the metatags include:
- www.tumorx.com, www.cancerx.org, and www.hopewelltechnologieslimited.com
homepages: cancer, Alzheimer’s, HIV/AIDS, diabetes, heart disease, memory mender, alternative cancer treatment, stroke.
- Acute Lymphocytic Leukemia (type of cancer listed on your websites): Acute lymphocytic leukemia treatment, cancer all, cancer breakthrough, stage 4 cancer, stage 3 cancer, stage 3 cancer, stage 1 cancer.
- Co-Enzyme-Q1O: Anti-cancer vitamin, virus cancer, Squamous cell carcinoma, heart disease, heart failure, diabetes, high cholesterol, breast cancer, chemo drugs.”
“We advise you to review your websites, metatags, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.”
Based on this letter, it is clear that the FDA a) knows what meta tags are, b) knows that they are used to attract visitors through Internet searches, c) is scrutinizing them in their monitoring program, and d) considers them relevant to certain issues of regulatory compliance.
So what does this mean for organic search results? We have a letter showing that the FDA is looking at website meta data in some cases. And we have two clear examples where the FDA has stated that the one-click rule is insufficient when content controlled by pharma companies makes a claim. The question is how likely is it that the FDA will apply the same thinking to organic search results?
At least one industry observer, the always insightful John Mack, editor of Pharma Marketing News, believes there is a risk. In fact, he warned that this could be an issue as early as 2009, before even the Novartis letter, and has since written several interesting posts on this subject. According to John,
“Without specific guidance, pharma marketers must rely on “received precedent” and the Novartis letter is such a precedent. It clearly warns pharma advertisers that the FDA is looking at metadata content when that content is controlled by the marketer AND becomes visible to consumers as in Facebook Share widgets. It’s only a short step from widget to natural search result…BOTH make metadata content visible and render the ‘Invisibility Rule’ defense questionable.”
One key difference, however, between the Novartis example and organic search may be that Novartis provided the means for users to share the content and thus could be seen as more actively and directly promoting the sharing of non-compliant content. But, again, there is also the question of intent. In the case of organic search results, it’s clear that pharma companies know how search engines use meta tags and craft them accordingly. On the other hand, what’s a pharma company to do? It can’t exactly prevent Google from using its meta tags. Should a pharma company be forced to change its tags, or remove them altogether, simply because a third party uses them and republishes them without permission?
Hopefully, this is something the FDA will address when (if ever) it issues draft guidance on the second of six topics it committed to addressing in September 2011: Fulfilling regulatory requirements when using tools associated with space limitations. Out of the six, this topic likely stands to have the most impact on the organic search result issue, and may even address it directly. But who knows.
So What Are the Options?
In light of the information above, I see 5 different approaches to take with website meta tags. I have listed these below in order of most conservative (least risky) to least conservative (most risky).
Option 1: Don’t use meta tags.
Well, clearly one option is to remove all meta tags from your site. Not a great option, obviously. Clearly, this is the worst approach for user experience, click-through rates on organic search results, and even (to the extent meta tags still have impact) search engine visibility. I have not seen one pharma brand pursue this approach, nor would I recommend it.
Option 2: Write Titles Tags and Meta Description Tags in a “Reminder” format.
This is the safest approach from a regulatory perspective since it eliminates the need for fair balance altogether. Note that a “Help-Seeking” format won’t work here, since the display URL will always include the brand name, which would constitute a claim if the condition is also mentioned. While the Reminder format is low risk, it also creates a sub-optimal user experience, since Page Titles may less accurately represent page content. More importantly, however, the Reminder format could negatively impact search engine visibility and click-through rates. Consumers overwhelmingly search on condition terms versus branded terms, and these important condition terms won’t appear in the organic results. In addition, without being able to mention condition terms the organic result will less accurately represent the website offering and therefore be less compelling to click.
When using the Reminder approach, it is important to look at the URL structure of the website to ensure that condition keywords are used and won’t be displayed. Many pharma websites, particularly for brands with multiple indications, use URL structures that include condition names which, if displayed alongside a brand name, would constitute a claim. (Check out Cimzia.com for one example.)
I know of at least two pharma brands considering this option, and I have personally seen only one example of this currently in practice—Rebif.com. I’m guessing there are others. And given recent activity with some of my current clients, I expect this approach to become more popular despite its drawbacks.
Option 3: In cases where a claim is made, include full fair balance in the Meta Description Tag.
Well that’s simple. Just include full ISI in your Meta Description Tag when making a claim. At least you can argue to the FDA that the content you control, your meta tags, is compliant. But there are two problems with this approach. First, given space limitations, including full ISI isn’t exactly feasible. Second, no search engine will ever display that content in its organic results anyway—they will typically display only the first 160 characters—and that’s on a PC, not a mobile device.
That said, this approach is the strongest in supporting the non-accountability argument. It allows a pharma company to essentially say, “Hey, we provide all the information. The search engine just chose to republish part of it. And, we might add, they did it without asking and, moreover, what they do is beyond our control. Therefore, the omission of risk is not our fault and we can’t be held accountable.” Hmm…sounds good, but I have to believe that the intent factor creates at least some risk.
Is anyone in pharma brand doing this? I have seen no examples so far.
Option 4: Allow claims to be made in meta tags without requiring fair balance, but implement some “rules” in writing meta tags to help mitigate the risk on non-compliance.
Below are some example risk-mitigating rules:
- Ensure that the full ISI is once click away
- Use condition keywords/nomenclature that are closely tied to the drug’s approved indication
- Include the full approved indication in the Meta Description Tag (this is often challenging given space constraints)
- Provide copy that encourages search users to click to read about important safety/risk info
- Position this copy at/towards the beginning of the Meta Description Tag to ensure that search engines will always display it, regardless of device (PC, iPad, smartphone)
- Include registered mark and generic name after the first mention of the brand name
- Take steps to increase the likelihood that Google will include “Safety Info” as a sitelink in the organic result (note: “sitelinks” are sub-links often displayed under organic search results)
- Add Important Safety Information as a standalone page on the website
- Give the page a properly-formatted Title Tag and Meta Description Tag
- Include the ISI page in a properly-formatted sitemap.xml file and position is as the second page behind the Homepage to communicate its relative importance to Google
- Implement links to the ISI page from every page of the site to reinforce its relative importance to Gooogle
There are many examples of pharma brands applying one or more of these rules. Take our Lipitor.com example. First, all of the Title Tags include the phrase “Safety Info.” I’m not sure how much this helps exactly, but at least Pfizer’s not shying away from the concept of product risk. Second, Meta Description Tags for all pages contain copy that encourages users to access safety info after the click. Below are some examples:
- “Learn about the risks and benefits of LIPITOR”
- “Get safety information for LIPITOR”
- “Find important safety information for LIPITOR”
This option allows marketers to make claims in meta tags while signaling to the FDA that the brand is making an effort to stay on-label and make people aware of the availability of risk information. The primary weakness of this option is that it relies on the “once-click rule,” which the FDA has already stated is insufficient in two other similar situations: paid search ads and social media sharing. But perhaps this option does just enough to let the FDA feel comfortable in looking the other way?
Option 5: Do nothing and write meta tags however you wish.
This seems to be a most common approach being used by pharma brands. Until the FDA weighs in on this subject by issuing guidance, why worry? What are the odds that the FDA will issue any warning letters? Given the current standard practice in pharma, they would need to issue letters to virtually any pharma brand with a branded website—which is pretty much all of them.
Ultimately, it will be up to each pharma company’s MLR committee to determine what level of risk they are comfortable assuming. But it’s clear that some risk exists, that essentially every pharma brand with a branded website is exposed to it, and that the issue should be on the table for discussion.
Before the time bomb explodes.