Sunday, August 8, 2010

FDA’s 1st Social Sharing Spanking: Was it the Medium, the Message, or the Metadata?

On July 29, 2010, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) issued a notice of violation letter to Novartis indicating that communications created by a social media sharing widget on several Tasigna Web sites violated the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations. The letter was made public August 5, 2010.

According to PubMed, Tasigna is a kinase inhibitor “used to treat certain types of leukemia (cancer that begins in the white blood cells) in people whose disease could not be treated successfully with imatinib (Gleevec) or people who cannot take imatinib.” Tasigna’s labeling carries a black-box warning.

The details of the letter indicate that the Facebook sharing feature of the social widget on Tasigna’s U.S. website generated communications that were in violation because they:
  • Failed to provide risk information (omission of risk)
  • Broadened Tasigna’s indication beyond what was approved (broadening of indication)
  • Implied advantages of Tasigna over other products (unsubstantiated superiority claims)
  • Implied the drug is more effective than clinical experience or evidence has proven (overstatement of efficacy)
The letter also pointed out that, while the website itself was submitted to FDA per regulations, the shared content was not submitted prior to use. (Failure to submit)

So What?
It should go without saying that this letter quickly received the attention of industry, with news articles, blog posts, and tweets swirling all day Thursday and into Friday. I think many of us in the industry realized it could have been any one of many companies that could have received this letter. Novartis, it seems, drew the short straw.

It’s important to note this letter represents several firsts:
  1. To my knowledge, it is the first DDMAC letter involving or even mentioning the use of social sharing tools (there have been letters mentioning YouTube in the past, but not tools like ShareThis).
  2. It is the first letter that mentions Facebook by name.
  3. It’s the first letter directly addressing metadata, even though metadata has been appearing in search engine results as long as there’s been Yahoo! and Google.
And while the FDA letter calls out Facebook specifically, in actuality, the issue was with Novartis’ use of the free ShareThis sharing widget – not really a “Facebook Share social media widget” as FDA stated. Either way, it’s important to note the implications of the letter likely reach all social sharing tools and even other situations where there are space limitations (such as search and mobile).

Many bloggers have already weighed in with their opinions on the letter.
  • For a consolidated list of articles and blog posts, see below. 
  • For more analysis and commentary on the letter from yours truly, read on ...
Essentially, the conversations have come down to the medium, the message, and metadata.

It’s the Medium
Social medium, that is. Was this an attack by FDA on social media?

Unless you’ve been living under a rock or are new to this industry, you’re aware FDA held a hearing on the Internet and Social Media in November 2009, and has indicated they will issue guidance by the end of 2010. FDA Special Assistant Dr. Jean-Ah Kang has been quoted that while FDA is indeed on track to deliver guidance this year, industry should meanwhile be on the lookout for letters that address some of the issues and questions surrounding pharma’s use of social media.

The Tasigna letter, I believe, may be the first in a series that will help provide clarity on some of the issues and – for better or worse – set some precedent for industry to begin to follow.

Even if Dr. Kang had not foreshadowed the letter, and even if guidance never does get published, the pharmaceutical industry is well-versed in adjusting its promotional approach by interpreting letters from DDMAC. And don’t forget 2010 is on track to be one of the heaviest letter-writing years in DDMAC history.

That said, digging into the details of the letter, it does not seem in fact to be an attack on the use of social media. Instead, it sent a clear message that the same rules apply no matter what medium is used. So was it the message?

It’s the Message
The basic principle of the violations read like many letters issued by DDMAC… omission of risk, broadening of indication, overstatement of efficacy. On first glance it appears Novartis was just sloppy with their use of social sharing. As Eileen O’Brien of Siren Interactive points out in her blog post, “It’s the Message NOT the Medium. This letter does not provide FDA guidance on Facebook. The important thing to remember is that this content did not follow existing FDA guidelines.”

Pharma must follow the known rules. The same rules apply in social media when it comes to indication, fair balance, efficacy, superiority claims, submission, etc. Pharma cannot afford to be careless – even with social media where guidance is sketchy at best.

By confirming that safety information must be included in any social media message -- other than reminders and even AFTER it is posted on the destination site (i.e., Facebook), the FDA is applying the same standard to social media as it has to other forms of pharmaceutical communications. Remember the infamous 14 NOV letters for search marketing in 2009? The message here is that FDA expects compliance with existing regs even if there are space limitations.

So if it wasn’t the medium, and it might have been the message, what’s all this discussion about metadata?

It’s the Metadata
Bloggers John Mack and Rich Meyer both jumped on the opportunity to educate their readers about metadata. Why all this focus on metadata? Metadata matters in this context because most social sharing tools pull metadata – or “data about data” entered into a Web site’s code – to generate the description that serves as the summary that gets shared. Metadata (which is, basically in this context, just words in the code) is generally “invisible” to anyone viewing the site, but is used by search engines and sharing tools to pull certain information about a site.
Site developers are able to define metadata, and some – but not all – pharmaceutical companies include metadata in their current legal/medical/regulatory review process.

I’m not connected to Novartis so I’m not sure what happened in this situation and why their metadata (and therefore their social sharing results) were not in compliance. But from where I sit, it’s possible that:
  • Novartis did not realize this metadata existed (a developer could have entered the code on a whim and it was soon forgotten) Novartis’ legal, medical, and regulatory committees may not have had any idea that this metadata existed and therefore had not reviewed it, corrected it, nor submitted it to FDA.
  • Consider this: One example of shared content, captured in the FDA letter from the Tasigna professional site, reads, “More information to Support your Patients.” Most review committees would not allow the inconsistencies in upper and lowercase letters in “Support” and “Patients."
  • It may be that review of metadata is just not part of their normal site review process.
  • The metadata was reviewed, but was not updated when the indication changed and/or when the social sharing tools were added.
  • Metadata was never reviewed or considered in the context of when the social sharing tool was added.
It is even possible the metadata provided by the site was too long for the character limits of the social sharing widget. As a result, the full indication information was cut off, making it appear as though Tasigna is appropriate for a broader range of indications. And the risk information may simply have been too long to be included at all. But looking closely at the wording of what should have been there and what ended up there, this is unlikely.

Still, it matters. If sharing tools and sharing destinations won’t allow content past a certain character limit, where does that leave branded content sharing that now requires indication and fair balance?

It’s All Three!
Some pharma companies have been using social media and social sharing tools for years. The industry called for FDA to provide guidance on the Internet and social media as a promotional medium. As I’ve said before, … be careful what you wish for.

Was it the medium, the message, or the metadata? It was all three. It was the medium because of the industry's hyper-focus on social media, it was the message because the content didn't follow existing guidelines for promotion in the first place, and it was the metadata because the offending content was pulled by the widget from metadata, which has its limitations.

While this letter has implications for many companies currently using social sharing tools on their sites, it does provide clarity on several key points. And? It’s not all bad news. So what do we now know as a result of this letter?
  • DDMAC doesn’t discriminate – consumer and professional sites alike are being scrutinized.
  • The same rules apply when it comes to indication, fair balance, efficacy, superiority claims, etc. Don’t be sloppy – even with “invisible” metadata.
  • Since fair balance being one-click-away wasn’t good enough for FDA, the myth of the “one click” rule-that-was-never-a-rule was, once again, discredited and debunked.
  • The biggest issue with social sharing is space limitations. This used to equate to mostly Twitter, but it applies to any social sharing where metadata feeds the content and 3rd parties such as the sharing widget or destination site may take liberties to shorten it.
There was potentially even some good news …
  • FDA did not outwardly prohibit use of social media, social sharing tools, Facebook, or even loose connections to user generated content.
  • FDA has always carefully considered the source of the offending content. FDA didn’t have a problem with user generated content, and all but implied that once the information is shared and out of pharma’s control, pharma is not liable. The key, however, is to make sure the content that IS within the company’s control is in line with current regulation.
  • There will likely be more letters – and hopefully eventually guidance – that will contribute to a framework of even more clarity around the use of social media by pharma in promotional materials.
In the words of Jim Dayton, our Emerging Media Director:
  • Social sharing is still very important; FDA didn’t say you can’t use these tools, they just clarified that in using these tools, the same rules apply around indication, fair balance, and risk.
  • Social media is not going away and the FDA letter issued to Novartis is not a game-changer. Nor is it a justification to stop using social media.
  • Instead, it has provided clarification as to the appropriate use of social sharing and has provided an opportunity to for companies to refine their overall marketing strategy.
  • By adjusting social media strategies to include these clarifications, marketers can better serve consumers, professionals, and regulatory requirements.
In the end, was it worth it? Were people really posting information about Tasigna to their Facebook pages? Were consumers “digging” content about a kinase inhibitor that treats Philadelphia chromosome-positive chronic myeloid leukemia? Or did someone slap a sharing widget on a site because - heaven forbid -  they thought it would look cool and thought that meant they were "doing" social media?

If there is anything to learn from this, it's that social is not a tactic. Social is not an icon you slap on your site. It is something that should be considered carefully, strategically, and with strong, pharma-friendly, tech-savvy partners who can help you understand the power -- and limitations -- of the Internet and social media tools.

Additional Resources – News
  1. ClickZ
  2. Dow Jones Newswires
  3. JimEdwards/BNet
  4. Pharmaceutical Executive 
  5. MMM Magazine
  6. MedAdNews/PharmaLive
  7. FiercePharma
  8. Pharmalot
  9. MediaPost

Additional Resources – Blogs 
  1. Eileen O’Brien/Siren Interactive
  2. WSJHealthBlog
  3. John Mack
  4. Jim Lefevere
  5. Digitas
  6. ReadWriteWeb
  7. Jonathan Richman/Bridge


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