DDMAC's Abrams Promises ‘Careful' Review of Presentations
by Mark Tosh, Editor-in-Chief, DTC Perspectives

DDMAC director Tom Abrams promised a careful review of the presentations and data as the FDA's two-day hearing on online promotion and social media came to a close Nov. 13 in Washington. Abrams also noted that the FDA staff in attendance heard from many of the presenters that the Internet and social media tools are “a different medium.” He did not, as was noted in some early reports on the meeting, explicitly acknowledge that FDA now believes the Internet is a unique medium that requires unique guidance and regulation.

• “We have heard a lot about the Internet and social media tools,” Abrams said in his concluding remarks. “And what we have heard is that 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.

In terms of “next steps,” which Abrams also acknowledged is the “big question,” he said a close review of the final docket – which will remain open until Feb. 28, 2010, will be required by the agency. “FDA's next steps include the review of all of this information. We will do this carefully so we get this right,” he said. “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.”

He added, “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.”

A few observers are hopeful that the FDA will address online promotion and social media before the end of 2010.

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COMPLETE TEXT OF TOM ABRAMS' REMARKS

Tom Abrams, Director, Division of Drug Marketing, Advertising & Communication, FDA
Concluding remarks at the FDA public hearing, Nov. 13, 2009

"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 objectives, 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.

We have heard a lot about the Internet and social media tools. And what we have heard is that 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 [and] it has provided us a wealth of information, comment 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 Feb. 28, 2010.

Next steps, I know that is the big question. FDA's next steps include the review of all of 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 of the valuable information they shared today and yesterday. We want to thank all of the folks in the audience, both here and viewing this by Webcast, for their attention, participation and listening, and interest in the meeting.

We would also like to thank Rochelle and Antoine 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 of the folks with FDA who worked really hard to make this hearing possible. It was not the easiest thing that these folks put together. Frankly, there are too many from FDA to name them individually….

However, we would like to recognize two FDA folks who have done an incredible job coordinating this hearing. They are Jean-Ah Kang and Barbara Chong. [Applause] Thank you for all your incredible hard work on this. We really appreciate it. To all of the speakers and staff, have a safe trip home. The meeting is now adjourned."

 

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