Monday, December 10, 2012

Social Media Guidance Countdown Continues: 576, 575, 574 . . .

Almost all of us dabble in social media.  We did when we posted this.  You are while reading it.  And we know that druganddevicelaw.blogspot.com isn’t all you do with social media.  Talking law is spine-tingling excitement, particularly drug and device law.  But we’d bet that you use social media for other stuff.  Lots of it.

The FDA knows.  It uses social media too.  Big time.  It tweets.  It Blogs.  It Facebooks.  It YouTubes.  It even puts little musical numbers on line. 

So the FDA gets it.  It certainly gets that pharma and medical device companies want to use social media.  That’s why it held a hearing on social media promotion and responsibilities in 2009. 

But, years later now, the FDA has offered precious little guidance about it.  We wrote about this in July, telling you that there was hope in the distant future because the Food and Drug Administration Safety and Innovation Act contained a section (1121) that requires the FDA to issue guidance on promoting medical products using the internet and social media within two years of the enactment of the Act.  Since the President signed the act into law on July 9, 2012, this means by July 9, 2014.

Well, there are signs that the FDA intends to use every bit of that time.  You see, in connection with the passage of the Medical Device User Fee Amendments of 2012, the FDA agreed to issue every fiscal year a list of the medical device guidance documents that it intends to publish in the next 12 months.  This November, it issued its first such list, which takes us close to the end of 2013.  And guess what?  It didn’t list anything on internet or social media promotion.  It didn’t even make the FDA’s B list, which are guidance documents that the FDA will publish if resources permit.

If we’re reading this correctly, it appears that the FDA will be taking us to, or close to, the July 9, 2014 deadline before it issues this guidance.  That’s almost 5 years since its hearing. 

Now, we get that regulating social media will be hard.  The pace of change in technology is breakneck.  The tools and sites change constantly and unpredictably.  The FDA needs data on the impact, use and understanding of the promotion of drugs and medical devices on the internet and social media.  And the FDA understands that, like with its guidance on print and broadcast ads, pharma and medical device companies will significantly increase their use of the internet and social media for promotion once the FDA issues such guidance.   

But this is what the FDA does.  It regulates.  This particular issue has been on its table for years, with the industry and all sorts of other stakeholders having already weighed in at the 2009 hearing.  It’s time to regulate, and not in an ad hoc fashion via warning and untitled letters.  Guidance is needed. 

It seems to us that the FDA should do something before July 2014.  The Food and Drug Administration Safety and Innovation Act says that the FDA must issue “guidance” on such promotion in two years, not “draft” guidance.  Maybe the FDA reads this language differently, but it seems to us that it signals that the FDA should get moving.  In any event, we’ll keep monitoring this.  We hope that our next post is dedicated to analyzing the FDA’s guidance, not our wait for it.

2 comments:

Krishna Patel said...

We are attempting to provide a forum where companies can compare their approaches in the vacuum of clear regulatory guidance - we even have former FDA counsel giving their candid insights! Hope you can join us http://www.americanconference.com/2013/829/advertising-promotions-and-digital-marketing-for-the-life-sciences-industry

Buy Pinterest Followers said...

It is so good to know that FDA is on social media. I will look for its tweets. Thank you so much, it's really a news.