Jan 7, 2011

FDA Delays Internet & Social Media Guidance, Don't Expect AE Reporting to be Addressed

DDMAC has delayed guidance until Q1 (or beyond) regarding new Internet and social media guidance. An excerpt from Eye on FDA, which first broke the story on December 21, 2010:  

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

Source: http://www.eyeonfda.com/eye_on_fda/2010/12/breaking-its-official-fda-delaying-social-media-guidance-until-at-least-q1-2011.html

Interested in a bit more detail, I decided to give DDMAC a call this week and had a good conversation with a contact there regarding the delay and draft guidance.  The information shared with me is that the goal is to get a guidance document out in Q1 2011 (but as we can see from the present delay this is a goal, not a commitment).

Most interestingly, the contact fielding my call communicated that their intent was to provide guidance that answered some of the questions posed as part of the public record (5 total) during the public hearings of last year (you can access the 5 questions here). I asked the simple question, “Which of the 5 would be addressed? Or, would all 5 be addressed?”  The interesting response was that they are seeking to address the first 4 and will not be addressing the issue of adverse event reporting (question 5).

This is very interesting as adverse event reporting is one of the largest challenges faced by the industry (that and off-label promotion/unbalanced promotion).

What do you think about FDA’s decision not to address AE reporting? Share your opinion in the comments.


  1. This makes total sense to me that DDMAC wouldn't address number 5. They actually don't have any jurisdiction over adverse event reporting. That's an entirely different part of FDA. I think they included that in the hearing so that their colleagues in that division (CDER?) could see that there's an issue.

  2. I would agree with you Jonathan. It would be addressed by probably CDER and makes total sense as to why this will not be addressed in the guidelines. Thanks for the comment!

  3. This may not be on FDA's list of "high priority guidances." See my Pharma Marketing Blog post about this: "FDA Says There are "No simple solutions" to Speed Up Its Regulatory Guidance Process" (http://pharmamkting.blogspot.com/2011/01/fda-says-there-are-no-simple-solutions.html). It may that the drug industry has to PAY the FDA to make it a high priority!

    I invite you to "sign" the 2010 Pharma Marketing Yearbook: http://www.pharmayearbook.com

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  4. Well said John. Will be interesting to see if the guidelines continue to be delayed....


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