Healthy Skepticism Library item: 19453

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Publication type: news

Schwartz M
FDA again delays promised social media guidance
Medical Marketing & Media 2011 Mar 30
http://www.mmm-online.com/fda-again-delays-promised-social-media-guidance/article/199595/

Full text:

The FDA has once again postponed the release of its first draft guidance for social media.

The federal agency was supposed to release the guidelines in late December, but stated at the time that it would delay the release of the first draft guidance until the first quarter of 2011.

Now that’s been put on hold.

In a statement, the FDA said: “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 most recent statement said that 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.

Emily Downward, senior VP of Edelman Digital Health, says PR pros are eagerly awaiting the release of the FDA’s guidelines on social media in order to provide better counsel to their clients.

“It makes it more of a challenge without the guidelines,” she says. “The only guidelines we’re getting is through warning letters. We equate [a lack of formal guidelines] with going through an obstacle course with a blindfold on. You don’t know what to do until you hit the wall.”

Asked what has been the biggest challenging about developing the guidelines, the FDA spokesperson added: “We are taking into consideration the 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2009), to develop multiple guidances on concepts that have long-term applicability so that they will not become quickly outdated as the tools and technology evolve.”