FDA public meeting on Internet promotion: regulated content meets emerging technologies by DLAPiper

VIEWS: 46 PAGES: 2

									DLA Piper | Publications | FDA public meeting on Internet promotion: regulated content ...

Page 1 of 2

News & Insights > Publications

Publications
16 NOV 2009

FDA public meeting on Internet promotion: regulated content meets emerging technologies
FDA ALERT

Kimberly K. Egan Rebecca Jones McKnight

In the past several years, methods of Internet communication have evolved at a breakneck pace. FDA regulations, however, have yet to specifically address many questions raised by the various ways of communicating on the Internet and through online social media. FDA's last major dialogue on this topic occurred at a public meeting in 1996. Think back to the way you used the Internet in 1996, and it should become clear how far this medium has progressed. The lack of specific guidance has left regulated companies trying to comply with FDA requirements crafted by Congress and regulators in a world long before Twitter. Last week, before a capacity audience, FDA held a public meeting to address the "continually evolving nature of the Internet." In announcing the meeting, FDA said it believed that many issues could be addressed through existing FDA regulations, but recognized that emerging technologies might require additional guidance on applying those regulations. Among the new Internet tools and technologies, FDA cited: Blogs Microblogs (such as Twitter) Podcasts Social networks and online communities Video sharing (through such sites as YouTube) Widgets and

http://www.dlapiper.com/fda-public-meeting-on-internet-promotion-regulated-content-m...

11/16/2009

DLA Piper | Publications | FDA public meeting on Internet promotion: regulated content ...

Page 2 of 2

Wikis FDA invited comments on the following questions: For what online communications are manufacturers, packers or distributors accountable? How can manufacturers, packers or distributors fulfill regulatory requirements (for instance, fair balance, disclosure of indication and risk information and postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)? What parameters should apply to the posting of corrective information on websites controlled by third parties? When is the use of links appropriate? What is the current reality of adverse event information received via the Internet? This meeting generated major interest. FDA received more than 800 requests for the 350 available seats. At the two-day event, speakers hailing from pharmaceutical and medical device companies; trade associations; Internet media, consulting and advertising firms; public interest groups; medical information websites; and even Google provided commentary and insight about their experiences. A number of speakers emphasized the enormous demand for reliable health information via the Internet, citing statistics about the ways Americans use the web to seek out information about symptoms, conditions and medical products. Speakers noted that general standards, such as the FDA requirement that information be "truthful and not misleading," present challenges in online media formats that emphasize brevity. PhRMA suggested a possible solution for online forums that lack sufficient space to allow complete information: including an FDA symbol that would be a clickable link to full prescribing information and patient medication guides. Several speakers noted the challenges to ensuring accurate information on the web when they do not and cannot control or even influence all web content related to their products. Rohit Bhargava of Ogilvy 360 Digital Influence suggested manufacturers should use "three Cs" as their guide in Internet promotion: creation (did they create the content or message?), collaboration (did they influence the content or message?), and compensation (did they fund the content or message?). Speakers from both PhRMA and WebMD noted that disclosure of the source of information is key. Wayne Gattinella of WebMD said the source of all information should be readily apparent to users; it should be clear what is independent editorial content, and what is advertising or sponsored content. A common theme among the speakers was that, although this is a challenging issue, it is one that is too important to be ignored. Although the meeting has taken place, there is still time for interested parties to weigh in on these important issues. FDA will accept written and electronic comments until February 28, 2010.

http://www.dlapiper.com/fda-public-meeting-on-internet-promotion-regulated-content-m...

11/16/2009


								
To top