Preparing for FDA Social Media Guideline Implementation

Preparing for FDA Social Media Guideline Implementation

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:

  • Risk prioritization. Identification of which drugs may be suitable for social media promotion.
  • Processes. Processes should be efficient enough for companies to realistically leverage social media platforms where information moves much faster than traditional communication pathways.
  • Approvals. A strong link between creative and marketing agencies, brand, legal, and regulatory review teams will need to be developed and tightly controlled and sufficient review and approval pathways should exist.
  • Governance. With constantly evolving technology, a governance structure should be set up to facilitate decision-making, provide guidance and oversight.
  • Monitoring. Monitoring should be set up to provide oversight of compliance with social media and other regulations, e.g., adverse event reporting and advertising.

Some steps that companies can take to facilitate compliance with these guidance documents, as well as prepare for potential future guidance documents, should include:

  • Inventory of company-owned social media sites. Companies should work to develop an inventory of their social media sites to enable oversight of the sites, platforms, accounts, and pages that they own
  • Controls for new company-owned social media. Development of controls and approvals to enable oversight new social media accounts or pages
  • Processes for approval of content. Development or modify processes for approval for content being posted to social media sites that are owned by the company to allow for efficient and effective legal and regulatory review of information
  • Auditing and monitoring capabilities. Auditing and monitoring capabilities to ascertain if all social media guidance and regulations are being followed should be implemented and auditors should be trained to deal with these new media outlets

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.
Comments on the draft guidance are being solicited through September 16.

Posted by Seth Whitelaw, Director, Deloitte & Touche LLP and Nicole Schumacher-Crow, Manager, Deloitte & Touche LLP

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