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5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

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The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media.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 www.nofocus.com/risk

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…

5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation

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Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices, which is the focus of this post. The other, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devicescan be read about in another posting.

In keeping with the tradition of most of these releases, 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. Brands may host open conversations on corporate-owned sites, without being responsible for the content.

This is surprising news, but the FDA’s own example for what its guidance entails opens the door for such communications. Beginning on line 141 the FDA writes,

“Example 4: A firm hosts a discussion forum about its drug’s or device’s FDA-approved use on its corporate website and does not participate in the discussion, but it does monitor the forum for profanity and obscenity. The forum includes an overarching clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for the information that is posted by independent third parties and can, if it so chooses, correct misinformation according to this guidance.”

For years, brands have struggled with the possibility of hosting discussions, particularly as they relate to educating patients and interested parties about how to use or stay compliant with a particular product. This statement by the FDA indicates that that activity is now approved for consideration. One caveat, the guidance does not release the brand/corporation from monitoring for possible adverse event notifications, only stating that the brand/corporation is free from responsibility for the content being posted by independent third-parties. Read More…

Is It Time For Pharma To Give Up The Social Media Ghost?

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Social media has been a big focus for pharma marketers for a while now. By my count, at least 30-45% of ePharma’s agenda from the 2014 NY conference was focused on the subject, and there is a whole cottage industry of other conferences specifically for social media fin the pharma industry. If you spend any time following pharma folks on Twitter, you can find tons of tweets on the subject and create whole feeds for hashtags like #socpharm, #hcsm, #pharmsm, etc.

I say it’s time to move on.

You read correctly. Before some of you go indiscriminately crazy and lambaste me in the comments for the mere suggestions that social isn’t important, let me offer some points of clarification. As it relates to corporate communications, I think using social media is a no brainer. For J&J, Pfizer, AZ, et. al., using social channels effectively is essential for reputation management, stockholder news, crisis management, etc. It’s the cost of doing business in the digital world we live in. Additionally, using social platforms to seed content is just fine, as long as you’re not expecting huge results. I’m a firm believer in a distributed content strategy, but 99% of the time, pharm brands place content in social platforms with the comments sections (or anything else even remotely ‘social’) disabled.

I believe the whole use of the medium needs to be seriously rethought. Simply put, there are serious challenges for using (and I mean really using) social media for a pharma brand. For instance:

  • Fostering dialogue and conversations isn’t the business that pharma brands are in
  • The marketing teams assigned to those brands aren’t built to sustain the kinds of relationships necessary to succeed
  • PR and marketing rarely coordinate within a given brand
  • The regulatory organizations (FDA or otherwise) will only let you discuss what’s exactly in the product’s label, and
  • Users, by all indications, aren’t interested in pharma infringing on their timelines and feeds

Defining social media
The term “social media” has been hijacked by the pharma industry, and thus, needs to be properly re-defined in order to better comprehend my argument. Social media, as defined by Wikipedia, is “…interaction among people in which they create, share, and/or exchange information and ideas in virtual communities and networks.” If you read this carefully, you begin to understand my point. Pharma does almost none of these things. While the creation of content is part and parcel to the pharma marketing regimen, I would argue that the minute your regulatory team requires you shut off sharing or comments features, the social media aspects of your programs cease to exist. If social media is about the collaboration of ideas and the sharing of communication, is it really a social program any more if the direction of those communications is entirely one-way? Read More…

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.