On November 12 and 13, FDA held a Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. The hearing represents FDA’s second attempt at gathering information on using the internet to promote medical products – the first taking place in October 1996. As we all are keenly aware, FDA did not issue any guidance to industry on the use of the internet as a result of that meeting.
The 12 member FDA panel listened to about 78 presenters over the course of two days. Although the panel asked a few questions, they made no suggestions regarding how they intend to address the two main issues as expressed at the hearing: How do the requirements in 21 CFR Parts 201 and 202 relate to certain internet/social media-related activities; and what are manufacturers’ responsibilities with regard to monitoring and subsequently reporting adverse events identified on the internet and/or through social media tools.
The hearing was mainly an opportunity for marketing agencies to “display their wares” with regard to the social media tools available to regulated industry, and to complain about the reluctance of industry to utilize these cutting-edge tools because of the lack of clarity surrounding industry’s obligations. Several companies and trade associations took the opportunity to discuss their participation in social media and what industry’s obligations should be. PhRMA was one of the few presenters that had a creative and specific suggestion on how to manage fair balace requirements in the social media world – the creation of an FDA logo along with a generalized risk statement that hyperlinked to FDA-approved product-related content. At least one presentation suggested that FDA consider requiring third party websites, such as drugs.com, to contain all FDA-approved product information. And finally, the problems with Sidewiki were addressed by many presenters, with the notable exception of Google.
The docket for submitting comments on the use of internet and social media to promote medical products remains open until February 28, 2010. Let’s hope that this time FDA doesn’t stick its head in the sand for another 13 years.