Tag Archive for: regulation

Today and tomorrow, November 12-13, the FDA is holding a historic public hearing regarding the “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.” This is the first time since 1996 that the FDA has examined the role of technology in pharmaceutical and medical device communication and advertising.

The FDA is looking at five questions, as stated in the Federal Register notice about the hearing:

  1. “For what online communications are manufacturers, packers, or distributors accountable?
  2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g. fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g. microblogs, mobile technology)?
  3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
  4. When is the use of links appropriate?
  5. Questions specific to Internet adverse event reporting.”
Two days of more than 75 presentations will attempt to cover the five questions. Speakers come from a range of categories: pharmaceutical, technology, research, advertising and others, as well as patient and consumer representatives. (For more background and updates on the hearing, follow NPR’s health blog Shots or the Wall Street Journal Health Blog.)


What’s also interesting about the hearing is how much the average member of the public can access within social media and on the Internet. There’s a live webcast of the hearing. A Twitter hashtag, #fdasm. A great site, http://www.fdasm.com/, compiled by Fabio Gratton of Ignite Health (@skypen on Twitter), which pulls together a live Twitter feed of the #fdasm hashtag and also includes robust information and links to additional resources such as a Google Docs spreadsheet with links to speakers’ materials.


Reporters and live updates are not allowed in the room (no reporters allowed, and no cell phone or wifi signals available), but in many ways, participating through these various social media channels allows a viewer a more robust picture and the ability to view the hearing and also to view and participate in the commentary about the hearing.


And there’s a lot of commentary about this event. For a few additional resources & people to follow online, check out:
Disclosure: Logos works with pharmaceutical and other health care companies.