FDA delays social media guidance until Q1 2011

SILVER SPRING, MD: The Food and Drug Administration postponed the release of its first draft guidance for social media until the first quarter of 2011.

SILVER SPRING, MD: The Food and Drug Administration postponed the release of its first draft guidance for social media until the first quarter of 2011.

The federal agency has said it is developing multiple draft guidances that will tackle how companies that market drugs, biologics, and medical devices can use social media and the Web for promotion.

A spokesperson said in a statement on December 15 the FDA had a “goal of least one [guidance] being issued in 2010.” A second statement, sent December 21, postpones the release of the first draft guidance until the first quarter of 2011.

The most recent statement also states 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; online communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet; and correcting misinformation.

The FDA declined further comment.

The federal agency has maintained that the same rules for fair balance and risk information for TV, radio, and print communications also apply to the Web.

But, in November 2009, the FDA invited dozens of industry leaders to a two-day hearing where agency officials gathered information about how pharmaceutical companies, advertising and PR agencies, Internet companies, and consumer advocates use the Web and social media in their communications.

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