Tuesday, December 08, 2009

FDA Public Hearings: Closing Remarks by Tom Abrams, director of FDA's DDMAC

Extracted from Day 2 (Nov 13, 2009) transcript of part 15 Public Hearing "PROMOTION OF FDA-REGULATED MEDICAL PRODUCTS USING THE INTERNET AND SOCIAL MEDIA TOOLS"

Tom Abrams:

"Wow, we made it through the two days. I just have a few closing remarks. We had a very full two days of interesting, diverse, and useful comments.

Taking a step back and looking at FDA's objective, we want consumers and healthcare professionals to have accurate, balanced, and timely information about medical products. FDA needs to ensure that promotion of medical products is not misleading and is balanced.

This objective is the reason why we conducted this two day hearing.

The Internet -- we've heard a lot about the Internet and social media tools. What we have heard is it's a different medium. It's one that provides information. It's rich in the information it can provide. At the same time, it's one that presents challenges.

Therefore, FDA wants to give this much thought as we determine the best approach to the Internet and social media tools.

FDA has much work to do in this area and one that we are determined to do. It's important and we will do it.

We want to have the involvement of our stakeholders. This hearing has been an excellent meeting. It has provided us a wealth of information, comments, and data. FDA encourages our stakeholders to submit your comments, information, and data to the open docket. As a reminder, the docket is open until February 28 of 2010.

Next steps -- I know that's the big question. FDA's next steps include the review of all this information. We will do this carefully so we get this right. It's too important of an area not to do it right as we want the best information about medical products for consumers and healthcare professionals.

The FDA panel would like to thank the speakers for their presentations and all the valuable information they shared today and yesterday. We want to thank all the folks in the audience, both here and viewing this by webcast for their attention and participation listening and interest in the meeting.

We would also like to thank Rochelle and Anton of the NTSB staff for their terrific, simply terrific, assistance and guidance with this hearing. They made it much easier for us.
We also would like to thank all the folks in FDA that worked real hard to make this hearing possible. It was not the easiest thing that these folks put together.

Frankly, there's too many from FDA that worked on this to name them individually. You met many of them in the lobby today and yesterday.

However, we would like to recognize two FDA folks who have done an incredible job of coordinating this hearing. They are Jean-Ah Kang and Barbara Chong. Thank you, Dr. Kang and thank you, Dr. Chong for your incredible work and hard work on this. We all appreciate it.

To all the attendees and speakers and staff, have a safe trip home. The meeting and now hearing is now adjourned."
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