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5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations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The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media.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5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation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Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about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…

Who Responds To The Responders?

This one is for you, Dan.

As I thought it might, my last post about social media stirred quite a bit of discussion. As such, I thought it would be useful to perhaps dedicate another post as a means of both clarifying my position, and providing some counter-points to the various responses that have been generated around the web.

To recap, my original post wasn’t meant to suggest that pharma should completely abandon social media, but rather that the interest in social engagements is over-calibrated when weighed against the potential business impact for a given brand.  There are two points that encapsulate my thoughts on how social most typically makes sense for pharma. First, for corporate communications, investor relations, and (hat tip to Craig DeLarge) corporate level customer service, social media makes a ton of sense. Second, placing content inside a given social platform, but turning comments off, relinquishes any hold on the notion of that program being even remotely “social.” While placing content in channels like YouTube can be a highly effective tactic, it ceases to be social without conversational interaction.

Those specifics being stated, a healthy debate has arisen to my point of view on this. That’s good. The industry needs more thorough discussion of the why and how communications should be rightly used to better inform all of us. But from my perspective, the counter arguments being posited just don’t hold much water.

Unbranded social media engagements provide real business impact
(Messrs. Mack and Spong)
There’s really only two situations where an unbranded program makes strategic sense for a pharma product; pre-launch, when the market needs to be seeded for a particular indication, and post-launch when a new disease category needs to be better understood by patients. I would argue that the latter makes less sense than the former, but I can see the rationale and so I’ll include it in the debate. 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…