Author: Elsa Abruzzo
It has been a busy couple of weeks; I’ve been doing some business traveling and in parallel amassing more hot-off-the-press material for our GPP Blog. Last week I was in Buenos Aires (BA) where there was no FDA presence, but there was fantastic food, polo matches, and tango receptions (yes, my friends the Argentineans can host a superb medical conference). In addition to the fun, I was working on how the big medical device firms can market to their international customers very differently than they can to their US counterparts—maybe fodder for another blog post. However in the Spirit of FIFO (first-in-first-out), the focus today is my trip the week before to San Jose, CA for the Regulatory Affairs Society (RAPS) Annual Conference and Exhibition.
The RAPS 2010 Conference was excellent and very well attended. In particular, I wanted to share some information and thoughts with you from Glenn Byrd’s (Director of Regulatory Affairs, MedImmune, LLC) presentation “Social Media and the Internet – Current Regulatory Issues/Challenges”. Mr. Byrd confirms what we have been saying all along in our little blog—despite the lack of guidance on the subject, social media and internet product promotions are viewed by FDA as promotional labeling subject to the same rules as other media. Basically, any activity that can create an interest in a product or influence a customer with respect to a product must communicate risk/benefit information in a “balanced way” and fully inform the audience of all “material facts.” Byrd provided two links you will want to check out: one is disease focused and the other is a corporate-sponsored direct site.
Byrd also provided a substantial list of FDA Social Media and Internet enforcement actions that are currently and “frequently” taking place despite the lack of a formal guidance to industry. These public enforcement actions include reference to “Facebook share social media widgets”, “non-product websites”, “consumer e-mails”, “product webcasts”, “online videos”, and “patient testimonials on websites.” The basic tenet is that these companies failed to disclose risk information either at all or in a balanced way. Also, even if your website complies with the FDA guidance “Presenting Risk Information in Prescription and Drug and Medical Device Promotion” issued May 2009, you could be at risk of infraction if you have hyperlinks that redirect to websites that do not contain risk information or mislead in some other way. Conversely, the inclusion of a hyperlink does not mitigate the lack of balanced risk information being presented in the directing website.
Based on the FDA’s Guidance risk/benefit presentation, does this even seem remotely possible in a 140 character tweet? Well, you can still use social media and be GPP compliant, you just need to be a little more creative. For example, you can tweet a 140 character hyperlink with a few non-claiming nouns (no adjectives please) that transports the viewer to another website with the room necessary to wax poetic on the risks and benefits of your product. Simply include the link to a compliant promotion website and refrain beyond that from any temptations to tweet benefits sans the risks. FDA will not accept your link as mitigation.