5 Key Takeaways From The FDA’s Draft Guidance on Interactive Promotional Media

This week, the FDA Quietly released it’s densely titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”

You can download and read them from here.

In keeping with the tradition of most of these edicts, these guidelines are drafts and may change over time, but in reading them there are 5 key things digital marketers need to be aware of.

1. If you own it, balance it.

This may seem like an no-brainer, but it’s almost always the reason that a brand will get a warning letter. A brand is responsible for all of the content it produces, whether on an owned property like a brand.com, or within a third party site like Facebook. If a brand makes any claim whatsoever, it needs to include fair and appropriate balance. Full stop.

2. Brands are only responsible for content that they produce.

This is great news for marketers as there has been a cloud of confusion hanging over the industry for a while. Brands are most often hesitant to engage in social media because of the unknown content that may be generated by users inside of a first or third party website or social media channel. While internal requirements over how to monitor and report potential user generated adverse event communications will still determined on an individual brand level, it’s helpful to have some clarification on the responsibility brands have for content that may be produced that is outside of its control.

3. Third Party Blogger Engagements Should Become A Larger Part Of The Communication Mix.

If a brand chooses to provide bloggers or managed communities with educational or promotional content, and it has no editorial control or oversight over how that content is used, then the FDA has determined said brand is not responsible for the resulting publications and engagements. When blogs became more attractive platforms for brands to pitch messaging, this was a key tool n the communication mix, but the practice has cooled quite a bit with the uncertainty of the FDAs perspective on the matter. This should hopefully rekindle what was a very effective and trustworthy way to engage otherwise skeptical communities.

 On line 136 it states “[…] if a firm provides only financial support (e.g., though an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for the information on a third-party site and has no obligation to submit to the FDA. Furthermore, if a firm is merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, the firm is responsible only for the content is places there, and, thus, is responsible only for submitting to FDA promotional content that was disseminated on that site.

4. Transparency Is A Must.
If you are going to engage in a community or real time platform, brands or their representatives must clearly identify their affiliation with the product. This, like the balance guidance from point 1 should be a no-brainer, but too often its overlooked.

5. FDA Submissions Of Real Time Interactions Do Not Have To Be Submitted Prior To Deployment
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Once a brand has launched, the content it produces inside of a real time channel does not have to be submitted to the FDA before it is deployed inside of a channel. So if a brand wants to respond to a message board or a Facebook post, it can do so without pre-clearing that communication. However, the FDA does require that brands periodically (monthly) submit all of the content it has deployed for review.

 

11 Responses to “5 Key Takeaways From The FDA’s Draft Guidance on Interactive Promotional Media”

  1. Mark Davis January 13, 2014 at 11:46 am #

    Points 2 and 3 are great news for content marketers and improve our ability to work with health activists. Also interesting in the review guidance, is that only a LIST of the sites where real-time interaction is occurring is necessary in some cases, rather than the entire threads. This will shake up some PRC conversations.

  2. Tyler Pennock January 13, 2014 at 1:27 pm #

    Thanks for this post. Making it explicit that we aren’t responsible for UGC within our own social channels should be a big relief. But I agree that the issues related to AEs certainly don’t go away – and that’s probably the biggest obstacle when trying to take Rx brands into realtime social engagement.

  3. Zoe Dunn January 13, 2014 at 1:37 pm #

    Yay! If you have no control then you can’t control it! Phew… Hmmm, the part about reviewing all the real time interactions periodically sounds to me that by the time they have reviewed them they will be buried pretty deep in SM so not sure what the point of that is… its a start anyway.

  4. Diane Vinch January 13, 2014 at 3:59 pm #

    With regard to number 5, I’m assuming this does NOT apply to Subpart H/Accelerated Approval brands.

    • Bill Evans January 13, 2014 at 4:30 pm #

      Diane- It’s unclear about Sub Part H so better safe than sorry. If you read through in detail it talks about post launch activities. Anything prelaunch would or “at the time of label issuance” should go to FDA.

  5. Debbie Donovan January 14, 2014 at 2:47 pm #

    Fantastic review. I will start thinking about how this information can be interpreted for medical devices.

Trackbacks/Pingbacks

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    [...] This week, the FDA Quietly released it’s densely titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Hum…  [...]

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    [...] This week, the FDA Quietly released it’s densely titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”In keeping with the tradition of most of these edicts, these guidelines are drafts and may change over time, but in reading them there are 5 key things digital marketers need to be aware of.1. If you own it, balance it.
2. Brands are only responsible for content that they produce.
3. Third Party Blogger Engagements Should Become A Larger Part Of The Communication Mix.
4. Transparency Is A Must.5. FDA Submissions Of Real Time Interactions Do Not Have To Be Submitted Prior To Deployment.Read more: http://www.doseofdigital.com/2014/01/5-key-takeaways-fdas-draft-guidance-interactive-promotional-media/  [...]

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