What “Big Pharma” Can Learn from “Little Startups”

First things first, hello. If you’re a new reader to the blog, you probably don’t remember me, but if you’re a veteran, you just might. It’s me, Jonathan Richman, the original founder and author of Dose of Digital back for a guest posting. After a couple of years out of healthcare (and away from the blog) at a startup focused on the restaurant industry, I’m back in the healthcare business. I recently left the startup…turns out I missed you all and felt like there’s more I can contribute to the healthcare industry. More on what I’m up to at the end of this post…you want the content, not the gossip.

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“Journalism”

My favorite line from the piece, got added AFTER it ran for days.

“Correction: This video was actually created by marketing students at Berghs School of Communication, and is not made by Google, nor is Google Gesture a real service. We updated the story below and apologize for the error.”

Link

5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations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The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media.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

fda

 

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…