Carrie Rose's picture

FDA Delays Social Media Guidelines

[[wysiwyg_imageupload:44:]]More than a year later, we continue to wait and see. The U.S. Food and Drug Administration (FDA) held a meeting in November 2009 to discuss the use of social media in the pharmaceuticals/healthcare space. First guidelines were expected to be announced by the end of 2010 and then in the first quarter of 2011. Well now they are delayed again! A recent Pharmalot article reports that “For the second time in four months, the FDA has apparently postponed plans to issue widely anticipated guidance on social media.”

According to the article, which also cites a related article from PRWeek, the FDA originally intended to release the guidelines in late December 2010, but postponed until the first quarter of 2011. The FDA stated that “it is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or ‘Good Guidance Practices' (GGPs), which ensures that FDA's stakeholders are provided well vetted guidances articulating FDA's current thinking on a topic.” The statement also explained that the social media guidances will focus on six areas: “responding to unsolicited requests, fulfilling regulatory requirements when using tools associated with space limitations, fulfilling post-marketing submission requirements, on-line communications for which manufacturers, packers, or distributors are accountable, and use of links on the Internet and correcting misinformation.”

An FDA spokesperson also stated that developing the guidelines has been challenging because the agency must take into consideration “input from within and outside FDA, including testimony and comments from the Part 15 hearing (from November 2009), to develop multiple guidances on concepts that have long-term applicability so that they will not become quickly outdated as the tools and technology evolve.”

The article also states, “This does include an FDA statement which says ‘Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities. Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources’.”

The pharmaceutical and healthcare arena continues to be in limbo when it comes to social media. When using social media on behalf of clients, it is important that we, as communicators, must continue to be careful and ensure a direct link is provided to all fair balance information when discussing products or devices.