Social Media, Twitter and FDA Guidances-Prescription Drugs and Medical Devices
FDA just released on June 17 two important draft Guidances for the FDA regulated industry specific to prescription human and animal drugs and medical devices for humans.
Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
The first draft guidance describes how manufacturers, packers and distributors of prescription drugs and devices should present both benefit and risk information within advertising and promotional labeling on electronic and digital platforms that have character space imitations such as Twitter, on the Internet, social media and or other hi-tech settings.
Major Points Articulated by FDA:
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 reconsider using that platform for the intended promotional message.
Character Space Limitations such as Twitter:
Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet); The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product.
A mechanism, such as a hyperlink, should also be provided within each individual character- space-limited communication to allow direct access to a more complete discussion of risk information about the product.
The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.
Guidance: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
The second draft guidance details how prescription drug and device manufacturers, packers, and distributors should respond, if they choose to do so, to misinformation generated and distributed by independent third parties on the Internet or through social media avenues.According to FDA appropriate corrective action by a company should:
- Be relevant and responsive to the misinformation;
- Be limited and tailored to the misinformation;
- Be non-promotional in nature, tone, and presentation;
- Be accurate;
- Be consistent with the FDA-required labeling for the product;
- Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
- Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
- Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.
The direct links are as follows:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf and
Benefit:
These two important guidances, although in draft format, provide the regulated industry with a more descriptive concept of FDA expectations. Although not legally binding, these draft guidances, unlike previous drafts specific to these issues, provide more direction and clarity to the regulated industry.
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