Digital Pharma: FDA delays social media guidance until 2011
pharmafile | December 22, 2010 | News story | Medical Communications | Digital Pharma blog, FDA, social media
The FDA will release its hotly-anticipated social media guidance for pharma companies in a piecemeal fashion, beginning in the first quarter of 2011.
The US regulator had been expected to issue draft guidelines before the end of this year, but with time rapidly running out for this deadline the delay is not altogether unexpected.
The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) confirmed in a statement that it has been researching draft guidance in six areas: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
• Use of links on the internet
• Correcting misinformation
The agency said: “DDMAC’s goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed.”
The guidance is the next stage in a process that began with a two-day public hearing on pharma’s use of social media and the internet in November 2009.
Since then the FDA has taken Novartis to task for the way it used a social media sharing tool, but has not yet found serious fault with any company’s direct use of sites such as Facebook, Twitter, Sermo or PatientsLikeMe.
Meanwhile, when they do emerge the FDA’s guidelines are likely to have an impact wider than their US jurisdiction. For the European pharma industry, unlikely to get its own hearing on social media, the rules may well become defacto operating procedures on this side of the pond too.
Dominic Tyer is web editor for Pharmafocus and InPharm.com and the author of the Digital Pharma blog He can be contacted via email, Twitter or LinkedIn.
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