The FDA has released new guidance regarding utilization of social media for advertising and promotion of pharmaceuticals and medical devices. This long-awaited guidance is the start of numerous specific guidance documents addressing defined issues in social media.
As companies search for new and effective ways to reach healthcare professionals through non-personal channels, the emergence of short-form media options is increasingly becoming a meaningful marketing and information dissemination platform. However, the legal, regulatory and safety professionals need to begin conversations with the commercial and marketing teams to take full advantage of the new communication channels, while remaining compliant. Effective processes and controls will need to be put into place to enable companies to leverage these platforms; and, in order to use these platforms, companies will need to have modified review and approval pathways to facilitate expedited approvals to keep pace with the speed of social media posting.
From the guidance it appears that the FDA’s biggest concern is that some social media platforms “may not enable meaningful presentations of both benefit and risk”, especially when products have complex indications or extensive serious risks. We believe social media promotion will not be a suitable promotion platform for most drugs, but pathways to utilize these mechanisms for low-risk products may develop. In deciding whether to take advantage of social media, companies need to consider:
Some steps that companies can take to facilitate compliance with these guidance documents, as well as prepare for potential future guidance documents, should include:
These steps not only directly address the recent guidance documents, but also help prepare companies for future guidance and regulation around social media. They also will allow for proactive monitoring of social media platforms for other risks, such as Adverse Events, reputational risks, and monitoring of potential off-label promotion situations. Therefore, it is not too early to get prepared to capitalize on these new channels for non-personnel communications with customers.
Posted by Seth Whitelaw, Director, Deloitte & Touche LLP and Nicole Schumacher-Crow, Manager, Deloitte & Touche LLP