2 min reading time

Last week FDA issued some social media guidance for medical device and prescription drug companies.

See http://medgroup.biz/FDA-social-media-guidance for commentary and the downloadable 18-page guidance.

In short, the guidance says if you need more room to reveal material facts than the medium allows, don’t use the platform. The main points for medical device marketers are:

1. It’s Every Time. Every communication you make has to stand on its own. From guidance,

“Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).”

2. Disclose the Risks. If you’re not cleared for use, for example, you must say so. Each time. From guidance,

“Benefit information should be accompanied by risk information within each individual character-space-limited communication.”

3. Not Enough Room? You’re Not Excused. From guidance,

“If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.”

Considering the universe of medical device manufacturers, I think the guidance will affect relatively few – because I think relatively few are using these platforms.

For discussion, is your company using Twitter or online paid search (e.g., “sponsored links” on search engines such as Google and Yahoo) which have limited character spaces?

If not, why doesn’t your company use these media?

If so, do you find any surprises in the guidance, or is it business-as-usual for you?

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Discussions This Week:

When, in your company’s lifetime, did you get your quality system?

How important is the development process for a new device versus an upgrade?

Do you believe smartwatches and fitness bands herald quantified selfing for the masses?

Medtronic and Covidien: Good or Bad for Minnesota? (500 votes so far)

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Make it a great week.

Joe Hage
Medical Devices Group Leader