FDA Asks Device Makers To Balance Benefit/Risk Info In Social Media

In long awaited guidance for industry on social media, the FDA this week asked industry to maintain a balanced amount of information due to “character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk.”

“These recommendations address the presentation of both benefit information and risk information in this setting,” Thomas Abrams, director of FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research, said in a blog post. “We understand that communicating on electronic internet sites with character space limitations can be challenging. But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information.”

He continues to advise industry to better provide a way for users to have direct access to complete discussions of all risks associated with products.

The FDA says when manufacturers communicate risk information on platforms with character space limitations, two particular points should be considered

The first is that risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet).

Additionally, the agency requires the content of risk information to be present within each individual character-space-limited communication. The risk should at a minimum include the most serious risks associated with the product, the FDA says.

On a more broad social media scale, the guidance also details a few specifics for industry to keep in mind, including:

• Any promotional labeling must be truthful and non-misleading.
• Any promotional labeling that makes claims about a manufacturer’s device must include certain information, such as the indicated use of the product and the risks associated with use of the product.
• Information required to be on a label must also, in layman’s terms, be placed on the social media site.
• Misbranding failure to reveal facts with respect to possible consequential use of the device must be represented as it would on normal labeling or advertising conditions.

The FDA adds that if a company finds it too difficult to include all of the necessary information in such a promotional message, “then the firm should reconsider using that platform.”

Comments on the guidance, which was released along with another draft guidance on how to correct third-party information, are due in 90 days.