Categories: FDA, Medical Device

As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).  FDA does not often reopen the door to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant.  In all three cases, FDA received communications from stakeholders requesting additional time to digest the guidance and formulate helpful (hopefully) comments.  However, the circumstances of the reopenings were markedly different.

At the time FDA reopened the comment period for its Draft Guidance: Informed Consent Information Sheet, showed that the Agency had already received about 350 comments.  Many of the comments praised FDA for addressing the persistent and increasingly untenable issues with excessive informed consent information for patients, but also observed that the proposed guidance might exacerbate the current problems.  The high volume of comments offered FDA perspectives from many different stakeholders on how to reduce the amount of information or make such information more understandable for patients.  However, the Agency still allowed additional submissions when Biotechnology Industry Organization requested more time to provide comments on a document of such "breadth and gravity."  This indicates that FDA appreciates how complex and controversial the informed consent issue is, and that the Agency desires full input from stakeholders to ensure that the final guidance is the result of a collaborative effort.

The social media draft guidances, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices, on the other hand, had garnered relatively few comments by the time the initial comment period closed. reported only 18 comments for the character space limited communications guidance and a mere 13 for the third-party misinformation guidance.  How is this possible given that the draft social media guidance has been the source of much interest and anxiety in the pharmaceutical and medical device industries over the past five years?  One possibility is that companies are still trying to figure out how the guidance will impact their marketing and general business strategies.  The character space limited communication guidance set out new expectations for promotions on certain Internet platforms, and companies may still be evaluating whether such promotions would be feasible with their products.  Another possibility is that FDA's strict adherence to traditional promotion standards for drugs and devices discouraged companies from commenting because, in the end, the draft guidance showed that FDA is unwilling to move away from those standards.

As of today, shows only 2 additional comments for the character space limited communications guidance and zero for the third-party misinformation guidance.  While I want to take this opportunity to encourage stakeholders to submit comments during the reopened comment periods for all three draft guidances (and even to submit additional comments if a stakeholder has already submitted), I want to focus on the necessity for comments on the social media guidances.  There are many open issues that FDA failed to address in both guidances, such as:

  • Companies' use of "like" and "retweet" functions
  • Companies' lack of control over which content is displayed as with Google sitelinks
  • The definition of "influence" when determining if a company is responsible for content on a third-party site
  • The use of media such as images and video on social media platforms

FDA needs robust input on the social media promotion issue to understand when traditional standards are not appropriate for the broad range of online marketing platforms and which alternative standards can provide more flexibility and a similar level of consumer protection.

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