The USFDA has published draft guidance (scroll down to read the draft) telling Pharma companies how to tweet about their products, and how to use other “Internet/Social Media Platforms with Character Space Limitations.” The FDA says it does not intend the guidelines to be enforceable as law and mentions, “The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
With that as the backdrop, the FDA says, “This draft guidance is … about how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices) that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling …on electronic/digital platforms that are associated with character space limitations – specifically on the Internet and through social media or other technological venues (Internet/social media).”
The guidance proposes that when using Internet/social media platforms with character space limitations for product promotion, firms should consider the following points:
— 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).
— Benefit information should be accompanied by risk information within each individual character-space-limited communication.
— If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should consider using that platform for the intended promotional message.
While the FDA goes to great lengths to illustrate with examples how this might be achieved, to do that within 160 characters would take some doing.
The FDA, however, does provide a way out by admitting the “Agency is aware of the challenges in balancing benefit and risk information within the character space constraints …” and saying that a concise disclosure of specific risk information accompanied by a link including “prominent reference to the presence and location elsewhere of a more complete discussion of the risks associated with the product …” might suffice.
The FDA has also concurrently published separate draft guidance for “Correcting Independent Third-Party Misinformation” on Internet/Social Media.
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