Challenges of facing up to FDA social media scrutiny
While FDA’s move should come as no surprise to those following the evolving regulatory environment for social and other digital media, it is disappointing nonetheless.
Not only does it suggest that regulators lack an understanding of how consumers use the Internet to find and act on health information, it reveals a continued tactic-by-tactic approach to enforcing pharmaceutical marketing regulations. FDA’s continued application of old broadcast tactics and rules to narrowcast environments, and limiting that application to one set of players in those environments, puts consumers increasingly at risk from misleading and false treatment information. Much of this false information is generated by “opportunistic feeders,” such as litigators and snake oil salesmen, whose online tactics are not given similar regulatory scrutiny (see v-Fluence FDA testimony on social media for additional information).
At the same time, no one would argue against the intent of these regulations; consumers should be protected against misleading marketing and have access to balanced information when making decisions about regulated health products online. Yet the result of this type of tactic-by-tactic approach to regulating new media leaves both consumers and product marketers disadvantaged and in some cases, counteracts the intention of those regulations.
For its part, marketing counsel at Novartis and other pharma companies should be aware of the nuances inherent in online content and ensure compliance departments are aware of them. While digital content development requires the same level of detailed review as both regulatory and company policy guideline compliance, lack of training and experience in these regulations when it comes to execution creates a challenge for well-intentioned company reviewers who may not be aware of the potential scrutiny given to “tags” and other non-visual elements that online content contains.
Sadly, this FDA warning may result in pharmaceutical companies slowing or pulling back from their already late entry into the social media arena, which has emerged as a critical starting point for people seeking information on disease prevention and treatment.
At v-Fluence Interactive, our dedicated health practice team members undergo up-to-date training in government regulatory requirements and industry standards on issues ranging from adverse event reporting to off-label promotions. Our approach of blending topic expertise with technical understanding of how digital media works helps ensure compliance, whether it be simple brand social media monitoring or execution support for complex new media outreach initiatives.
Author Shae Johnson leads the v-Fluence Interactive health and pharmaceutical policy practice team. v-Fluence uses topic-dedicated analysts and digital tactic experts to provide industry-specific counsel and online execution support with topic and therapeutic area monitoring, website and digital resource evaluations and Internet environment analyses