The FDA recently issued draft guidelines that impact how pharma can communicate in social media, but leaves many in the industry underwhelmed.

The guidance addresses only off-label information. It doesn’t cover on-label promotions, which means the industry can continue to communicate using this channel.

These guidelines provide instructions for pharma on addressing unsolicited off-label questions presented within a public arena, like a forum or chat room.

What industry can do:
If a question about off-label use is stated in a public arena (i.e., within a social media forum), the company may publicly provide a response. This response should:

1. Convey that the question pertains to an unapproved use of the product, noting the approved indication and safety information, and
2. Include the contact information for medical affairs, and
3. Only link to the product’s package insert. Links to promotional websites or third-party websites are prohibited.

Lastly, the firm should record the person requesting information and any follow-up questions from the requestor.

Industry agrees that these guidelines shouldn’t prevent companies from getting involved in social media. As long as they act in the spirit of the law, communicating in social media shouldn’t be inhibited by the lack of more specific additional guidelines.

Recently the FDA has given a great deal of attention to video, and pharma companies are grappling with the best way to communicate through this medium within regulatory boundaries. DDMAC is focused on identifying videos that overstate benefits and minimize risks, with the most recent letter issued was on a patient video on Premarin.com. According to the letter, the video overstated efficacy of Premarin by suggesting that it would eliminate all hot flashes and other symptoms associated with menopause. Additionally, it minimized side effects – available on the website only in text, under the video player.

Similar circumstances led to warning letters for brands such as Eisai’s Gliadel, which included voiceover of the risk information, but lacked prominence. A video on Herceptin had a different, but no more successful approach. Risks were presented in text only prior to the start of the video, and very little risk information was integrated into the video. Patients noted “mild fatigue” and “joint pain,” hardly a thorough discussion on risk that should accompany a product with a boxed warning.

Where to Go From Here

Benefits of a product discussed in a video should be on-label, of course, when delivered by any spokesperson. Thorough preparation, detailed screening and a highly trained interviewer can go a long way in eliciting responses that are natural, yet appropriate from the FDA’s perspective. Capturing physician footage to accompany the patient story is a best practice, particularly as physicians will cover side effects more comfortably and naturally.

Online videos should follow the same approach as contemporary DTC commercials. Safety/side effects/risk information should be integrated into the content of the video itself. It should be part of the story narrative, not a before or after thought like the videos cited above.

Further, “balance” should be as consumer friendly and natural as the discussion of benefits. Accompanying any contextual balance should be the full ISI, integrated in the video itself as well as on the page. The ISI should not be minimized by distracting visuals and other competing elements.

Planning for Success

Planning for video success begins sooner than the editing suite. With proper planning and expertise the integration of risk information within video is an achievable best practice that will increase credibility, drive understanding/comprehension and share risk information in a digestible format. And make FDA happy.

In February 2004, the US FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) drafted guidelines governing the creation of unbranded websites, which spelled out rules that marketers should follow. Breaking a number of these rules resulted in Novartis receiving warning letters from DDMAC back in April about two of the company’s unbranded sites: www.gistalliance.com and www.cmlalliance.com.

Where Did Novartis Go Wrong?

Both Novartis sites were deemed to be overtly promotional of the Novartis therapy, Gleevec. Here’s where the sites went wrong:

• Promoted the use of Gleevec outside its indication and made unsubstantiated dosing-related claims
• Were “perceptually similar” in terms of color schemes and layout to the Gleevec site
• Included “representation or suggestion relating to a particular drug,” including: direct links to the Gleevec product website; references within a publication on the site to a pivotal Gleevec trial; and footnotes on the site that referenced imatinib (Gleevec’s established name), and prominently featuring the Novartis logo
• Did not provide fair balance. While unbranded awareness and education programs are not subject to fair balance requirements, the FDA has taken the stance that it is required if the unbranded program “impliedly identifies a particular drug”
• Mentioned a tyrosine kinase inhibitor (”TKI”) for the first line treatment of GIST and CML. Gleevec is the only TKI indicated for first-line treatment of chronic phase CML, and the only TKI indicated for first-line treatment of GIST
• Contained registration opt ins without being clear they were opting into receive “product information” that delivered Novartis communications, promoting Gleevec

Following the Rules

If you’re looking to develop an unbranded or disease awareness website, be sure to adhere to the guidelines outlined by DDMAC:

• Be clear, accurate and reinforce a public health message
• Refer consumers to an HCP for more information
• Ensure the unbranded experience has its own creative identity
  • Use a separate color palate, as well as different visuals and models, from the branded experience
• Review treatment claims as if the piece was branded
• Follow the same strict regulatory guidance in the way the statements are crafted and substantiated
• Provide balanced treatment discussions
• Provide clear opt-in options for consumers, including a double opt in procedure

Following the rules not only helps you avoid a warning letter, it allows you to capitalize on an opportunity to better educate and enhance the value of your sites. In short, you can break through the clutter without breaking the rules!

On July 29, 2010 the FDA issued a warning letter to Novartis for the Facebook share button and sharebar on the Tasigna product website – both consumer and HCP sides. The issue was that when a user clicked the share button, it displayed a post on the user’s Facebook wall. The post was a statement (that varied by page) that typically included the brand name and the indication. It was a brief statement with a link to the website, so of course it did not include fair balance. Further, language within the statement used on some of the pages used superiority language that FDA had previously told them not to use.

So, what does this mean?

First, just as in the instance of the Gleevec unbranded letters this spring, it actually changes nothing. Novartis, for the second time this year, simply violated known and understood DDMAC policies. It’s shocking, actually, that after the unbranded letters, that they did not do a better job following well established rules in the rest of their communications (particularly interactive communications).

This letter is certainly NOT a new FDA policy prohibiting the use of share tools or social media in branded pharma. It does reinforce the FDA policies regarding claims and balance and that channel and format does not change the rules. As with all things, the devil is in the execution.

What concerns us, is that, as with the unbranded Gleevec letters, the industry will overreact and start pulling back on their investments or efforts within social media. This should not be our response; we should take this as confirmation that DDMAC sees the internet and social media the same as every other channel and applies the same rules. We as an industry just need to accept that fact and follow the rules!

First, let’s take a look at why the search engines should be responsible for having to change the way the results are displayed. No matter what search engine you use, none are proficient at semantic search. For instance, take a look at the result set returned on Hakia for the search query “how can I treat my heartburn?”. As you can see, the intent of my search wasn’t fully understood, and it appears to simply match the terms in my original query. What this means is that text analysis is still a critical factor when determining what pages/sites to include in a result set. Therefore, including targeted disease-state terms in your titles is still going to make a difference in the success of any SEO campaign. Now I know that not including keyword in a title tag isn’t the only reason a site would/wouldn’t rank for a targeted term, but I’m not the only one that knows it matters (just look at #1 under On-Page Factors)! Along with this, at the Social Media hearings that were held recently, Google already stepped forward and showed examples of possible Paid Search ad formats that would be used in order to abide by the FDA’s rulings.

So what have we learned from this example? The engines have the capabilities to alter their results, it’s now just a matter of them doing it.

As we all know, the engines have enhanced results for different verticals. It’s now time to apply those enhanced results styles to pharma. Although a scalable solution that could be supported by all major search would be optimal, for the purposes of this post I will be giving examples that are engine specific. Here are just a few ideas/examples of what the engines currently are doing for other vertical results, and how they could be applied to pharma:

Bing & Document Preview

Bing has a pretty sweet feature called “Document Preview” which allows for a user to gain some understanding as to what a particular result is all about. As you can see in the above example, AJAX is used to display part of the page’s content (ironically enough, the preview above shows the user the Safety Information) when the user hovers over the result. Currently there is only a way to block MSNBOT from adding the document preview via the <meta name=“msnbot”, content=“nopreview”> meta tag. What this leaves open is the ability to implement a directive that tells MSNBOT what content to actually include in the document preview (I’d imagine it would be a microformat / RDFa that was specific to Bing). This would enable a pharma webmaster to mark up the PI, or whatever content is desired to be included that preview.

Microformats & RDFa for Pharma

This is a more scalable solution, that if adopted by all engines risk information could be included in all pharma results. As you may already know, Google and the soon defunct Yahoo! support microformats and RDFa which help them provide enhanced listings for sites in their indices.

Above is an example of a Yelp result that utilizes the hReview-aggregate microformat. This allows Yelp to provide additional information, such as average star and price rating. This sort of enhanced listing would perfect for pharma SEO because of the fact that is could provide a direct link to safety information and it could be supported by all major search engines. A webmaster would simply have to go in mark up the safety information on a page with the correct microformat and they would have an enhanced listing (obviously this is somewhat oversimplifying the process, but you get the picture).

So, what do you think? Do you feel that it is up to the SEO to simply change how their results are displayed in order to comply by future FDA guidance, or should the engines show a little love and make the SERPs a little more pharma friendly?