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FDA Official States Need for Greater Data from Public Stakeholders and Industry to Inform the Guidance Process for use of Internet and Social Media in the Promotion of FDA-regulated Medical Products
Date:2/9/2010

nts in the docket or submit your own, go to www.Regulations.gov.  Use docket #FDA-2009-N-0441).

"We really do want comments," states Dr. Kang.  "It's really important to us. This is the chance for the public to really be actively involved because we are going to review all the data and comments. We're going to take them all into consideration and that is going to be the basis for next steps so I really encourage public involvement.  This is a challenging issue but it's also an exciting time.  We as an Agency encourage people to actively be involved and participate in whatever way that they can."  

According to Dr. Kang, the DDMAC official leading the efforts around guidance and policy issues specific to the Internet and social media at the FDA, the information presented at the Part 15 Public Hearing was a critical first step of the overall guidance process, a step which enables the public to participate and share their perspectives on the topic in the Federal Register notice.  Dr. Kang emphasized the importance for organizations or groups to submit new data or continuing research whether it's gathered through focus groups, online surveys, or even gathered from observing how people interact with fictional drug promotion on search engines and health portals.

"The FDA is a data-driven agency so if you have data to support a particular opinion or a position on an issue, that's really important.  A lot of our decisions are based on having good, solid, robust data," said Dr. Kang.

Dr. Kang also expressed that, while the FDA is working to collect all of the information by the February 28 deadline, they will continue to accept comments after th
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