FDA pharma social media ‘guidelines’ leave pharma wanting

While most of us (myself included) were preoccupied with our holiday celebrations, the FDA quietly released a Social Media guidance.

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?

 

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4 Responses to FDA pharma social media ‘guidelines’ leave pharma wanting

  1. Krista says:

    It’s no surprise that the FDA issued these guidelines around the hoildays and without any press release– that’s their MO of sorts that I grew accustomed to when working in healthcare PR.

    I guess the industry can take some solace in the fact they have some feedback from the agency for off-label issues, which is a hot-button issue when using social media to begin with for many of the large pharma companies. Working in an educational institution with an intricate bureaucracy, I can only imagine the level of difficulty in getting anything done at the federal level! If there is one thing I remember from working in the industry, it’s that patience is a virtue and it doesn’t mean there’s no reason to be social with communications. Let’s hope the next round of guidelines don’t take as long but I’m sure many folks are waiting for the long haul.

  2. Hi again Josh,

    Addressing off label usage questions has typically been mentioned as a key sticking point for pharma social media engagement. So this is at least a start, yes?

    I’ve yet to see confirmation that the FDA actually framed this as the long awaited guidelines the industry has been clamoring for. Is this the case, or are we (myself included) all simply assuming this is it?

    Hope the holiday celebrations went well, Sir. 🙂

    Cheers

    Jason Boies
    Radian6 Community Team
    http://www.radian6.com/

    • Joshua Brett says:

      Hi Jason, and Happy New Year to you! It’s a start, but I’m afraid putting out a guidance piecemeal is not going to resolve the confusion. Will we have to wait another 2 years to get the next part? Why can’t they just put out the whole thing at once after 2+ years? Government moves maddeningly slow, but really?

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