The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media.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