The more things change….

November 6, 2009 at 12:29 pm | Posted in Communications strategy, Digital strategy, Multimedia, Regulation, Social media | 4 Comments

Add the Food and Drug Administration to the list of those following how social media is transforming communications. In this case, the subject is the promotion of FDA-regulated medical products — including prescription drugs for humans and animals, prescription biologics, and medical devices – “using the Internet and social media tools.”

To gather comment from parties interested in this topic, the FDA has scheduled a public hearing November 12 and 13. There’s plenty of interest – registration for speakers and attendees is closed. You can follow the hearing via a free webcast . The agenda is here.

For those of us old enough to remember, this is especially interesting since we’ve been here before – on October 16 and 17, 1996, to be exact. That’s when FDA held a public hearing “to discuss issues related to the promotion of FDA-regulated medical products on the Internet.” Topics covered at that time included investigational product information, chatrooms and newsgroups (remember those?), and Web site links. The FDA has fired up its wayback machine and helpfully provided a transcript of that meeting.

There was widespread expectation that that hearing would yield specific guidance on using a then-new communications medium to promote, market or just plain discuss regulated medical products. As it turns out, FDA didn’t issue such formal direction, instead advising marketing/communications types to follow existing guidelines, which were developed with print and broadcast in mind. As I recall, the idea was that the net/web, while a new medium, did not necessitate a whole new set of regulations for proper use.

Thirteen years later — an eternity in Internet time — the digital media landscape has changed dramatically, of course, with an explosion of new technologies — particularly social media. But what about the core issues?

The FDA, in its Federal Register posting on the new hearing, has identified five areas to be explored in this latest hearing:

  • For what what online communications are manufacturers, packers or distributors accountable?
  • 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/or real-time communications?
  • What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
  • When is the use of links appropriate?
  • Questions specific to Internet adverse event reporting.

All good questions, but when asked in the formalized setting of a public hearing by a regulatory agency, they underscore how policy can lag market/user demand and behavior when it comes to fast-moving developments in communications.

There are other instances of this, of course. For example, Susannah Fox of the Pew Internet and American Life project, one speaker at a meeting I’m attending on consumer health informatics, spoke today about security issues related to the broad adoption of electronic health records.  She noted that the federal law governing health information privacy dates from 1996, barely two years after the Web was born. Final regulations were issued in 2002, but even that date is years removed from the current explosion in the development and use of online medical and health information.

Will the latest FDA hearing on social media raise substantive new issues that prompt the agency to act in any way different than it did more than a decade ago? Stay tuned.

Advertisements

4 Comments »

RSS feed for comments on this post. TrackBack URI

  1. […] This post was mentioned on Twitter by Brian Ahier, SusannahFox. SusannahFox said: History lesson: Bill Silberg on the FDA's Internet Public Hearing…in 1996! http://bit.ly/4twK5c #fdasm […]

  2. Social comments and analytics for this post…

    This post was mentioned on Twitter by SusannahFox: History lesson: Bill Silberg on the FDA’s Internet Public Hearing…in 1996! http://bit.ly/4twK5c #fdasm…

  3. And it must be noted that the pharmas are tweeting their brains out, from the floor of medical meetings. (PLATO study findings from ESC, etc). I find it useful but I am watching this with interest to see if DDMAC has anything to say.

  4. True words, some truthful words dude. Made my day.


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Blog at WordPress.com.
Entries and comments feeds.

%d bloggers like this: