FDA Social Media Hearings: Day 2
As two jam-packed days of testimony near a conclusion, one powerful theme continued to resonate from drug and device companies and associated vendors: If emergent FDA regulations on participation in social media are so onerous that they serve to deter drug and device makers from being in this arena, the commercial stage will be entirely left to unregulated entities including marketers of alternative health remedies, off-shore pharmacies peddling potentially counterfeit or unapproved therapies and a tidal wave of law firms provoking panic about branded Rx products in an effort to recruit vulnerable consumers for class action lawsuits. This result, it is argued, creates a vacuum that would leave the Internet the sole commercial province of companies whose messages and products aren't validated via clinical trials or accountable in any way to the FDA.
The Agency was repeatedly implored to collaboratively identify and establish responsible but practical, realistic ways to enable responsible industry participation in social media. Among the oft repeated suggestions was for FDA to recognize that regulations must be tailored to the unique technology attributes of social media channels and tools, and mindful of the staggering volume of content generated every second.
Vehemently crusading against allowing industry to more easily participate in social media was a spokesman from Consumer's Union, who warned FDA to not repeat what he asserted has been the dire consequence of DTC advertising in traditional media. The Internet, the spokesman warned, only offers more opportunity for deceptive and sinister marketing practices by an industry that he apparently believes is not to be trusted.
Social media, industry argued, could actually help FDA better achieve its public health and safety mission with respect to effective communication with the public. Current regulations mandating comprehensive detail of all labeling and safety information, regardless of format, it was stated, result in a blur of fine print or voice-over garble that nobody can read, hear or understand. It was argued that these regulations serve as more of a legal mandate than an effective communications mandate.
Through Its interactive, linking, searching and click-through capabilities, industry advocates contended, social media offers tools and formats that could be mobilized by companies and FDA alike to establish a new paradigm for communicating accurate and understandable health information in a simpler and more accessible way to the public.
Many terrific, specific suggestions were illustrated. One can only hope the FDA was truly listening.
Posted by Lloyd Benson on November 13, 2009 at 3:36 PM
