In June 2014, the FDA issued two guides for social media, and more recently a third:
- Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
- Internet Social Media Platforms with Character Space Limitations
- Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
This week I have key takeaways from the second guidance, specifically ones for Twitter (the guidance also addresses sponsored link promotions).
In 140 characters, a product tweet must include:
- Brand and generic names
- Benefit information
- Risk information
- Link to complete product risk information
Here the FDA’s example of a tweet for a fictitious drug, NoFocus:
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder http://www.nofocus.com/risk [134/140]
For a breakdown on how the FDA constructed the above example, start at page 7 of the guidance document.
A few other things:
- The FDA will allow use of shortened URLs to link to the complete discussion of risk, saving valuable characters.
- Note that a “reminder” promotion, which calls attention to the name of a product but does not make any representations or suggestions about the product, is exempt from many of these labeling and advertising disclosure requirements.
- And “Eye on FDA” by Mark Senak of Fleishman-Hillard presumes, “If FDA would tweet a drug approval – “XYZ Drug approved by FDA for diabetes Type 2″ – the manufacturer would presumably not be allowed to re-tweet the FDA’s announcement. Below is an example of such a tweet, and I noticed the manufacturer did not re-tweet.
Net — if you cannot present full benefit and risk within the character space limits, then you should not use that outlet for advertising and promotion.
On July 10, the FDA hosted a Social Media Guidance Webinar; click here for the slides.
Next week Mark Senak will host his own webinar on the guidances – sign up here.