5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations

The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media.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…

Are Meta Tags a Regulatory Time Bomb?

Are Meta Tags a Regulatory Time Bomb?

Your branded pharma site is non-compliant. Yes, yours. Paying attention yet? As pharma marketers, we operate in a world governed by strict rules. As digital pharma marketers, those strict rules can often be ambiguous, poorly-defined, or simply absent, requiring us to interpret vague requirements and/or extrapolate from other (presumably) relevant precedents. (Yeah, I know, it’s almost exactly like having a girlfriend.) Which brings me back to your Brand.com. What’s to worry about, you say? Everything’s ship-shape, buttoned-up, right? On-label messaging, appropriate fair balance, all content submitted and approved by the…

Applying Some Sanity to a Regulatory Debate

Applying Some Sanity to a Regulatory Debate

Okay…today’s post is a bit of a rant, but I think it’ll include some practical, rationale advice that will help you too. As you can tell by the featured image for this post, I find myself out of ideas on how to explain my point in a calm, bullet-pointed way, so I’m going with the rant approach. I’d like to thank a number of you for both adding clarity to my thoughts and for being the very inspiration behind this post (you each know who you are). What am I…

Digital Alert and Reco: FDA Warns Novartis Over Facebook Sharing

Digital Alert and Reco: FDA Warns Novartis Over Facebook Sharing

[UPDATE, Sept. 29, 2010: Our recommendations and guidance have changed since we made this post. Check out this latest post for the update.] Last week, the FDA issued a Warning Letter for the website for their drug, Tasigna. The main issue in the violation was content that was shared via social media. The Tasigna site had Facebook sharing buttons that, like other sites, automatically generate content for sharing. The content of this content is what the FDA cited. This content is drawn from META description tags on the website. These tags…