January 2, 2012 4 Comments
Sort of, anyway.
Ad Age‘s Rich Thomaselli reported last Friday that the FDA announced new Social Media marketing guidelines for pharmaceutical companies. But the document, titled “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” only covers the discussion of off-label information.
For that reason alone, it falls far short of what the pharmaceutical industry not only was looking for, but needs.
“What everybody was expecting was actual guidelines around social media,” Jim Dayton, senior director of emerging media for Overland Park, Kan.-based InTouch Solutions, a pharma-centric digital-marketing agency, told Ad Age.
“I still think it’s monumental,” he added. “The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn’t happen here.”
The document provides pharma companies with instructions for responding to consumers who use Social Media to ask about potential off-label uses for prescription drugs. A thorough, complete Social Media guidance – the kind the FDA held a public hearing more than two years ago to develop – would have been far more encompassing. Perhaps it’s no wonder then that the FDA released these guidelines during the Holidays (when they’re less likely to get noticed) and did so without even a press release.
“We understand the level of interest and wanted to get out what we had available to provide guidance,” FDA spokeswoman Karen Mahoney told Ad Age. She also added that this was just “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009.”
But when will those guidances come? And why does it have to be done piecemeal? This is all the FDA could get done in 2+ years?