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20 years

Monday, November 9, 2009

Will they be flexible?

This week, the U.S. Food and Drug Administration will hold a public hearing on Social Media. The formal name of the hearing is Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (http://edocket.access.gpo.gov/2009/E9-22618.htm).

Catchy name huh? But there's hope in the government speak. We all know how the internet and social media have dramatically changed our lives. They have provided access to information, research and data for patients and caregivers. We can be much better informed on almost all aspects of health and wellness.

Yet this explosion scares regulatory agencies such as the FDA. The Agency has enough on its plate with drug approvals, monitoring what's being used, tainted products like peanuts and spinach, dealing with approved marketing and promotion of products within label.

The hearing is the hottest ticket in DC this week. Only 60 speakers allowed, and 800 people asking for seats in an auditorium that only seats 300. From what we've heard, the FDA first wants to listen to different views - ranging from large pharmaceutical and medical device companies and their associations, to Google and Yahoo, to web site and content developers. The first day is more general, the second day is more focused on Adverse Events. After the hearings, the speakers will also add comments for the record. If you can't get there go to http://www.fdalive.com/webcast.cfm for the streaming video.

We believe that if the FDA decides it needs to create rules for social media, they should be as flexible as possible to accommodate technological changes and new applications. For example, if FDA had created rules last year, the Agency would already need to adjust due to the explosive growth of Twitter.

Here are some of the questions that FDA must grapple with:

If the Centers for Disease Control (CDC) can use Twitter, Facebook and other social media to communicate info on public health issues such as H1N1, why can't regulated drug and device companies use the same technology to communicate (perhaps with links to ensure fair balance)?

To what extent are companies responsible for technologies such as Sidewiki which make it look like information next to the company or product site might be viewed as company sponsored information? We doubt the FDA would risk a fight with Google and try to ban such web innovations?

How can Social Media help companies do a better monitoring AE's (adverse events) for their products?

Should companies be required to monitor the entire web for any mentions of their product?

We hope it's an informed and open discussion that helps FDA provide proper control and guidance for regulated products in a Wild West world.

Visit http://bit.ly/MWy5w for our Video blog on this subject.

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