FDA social media guidance delayed again….until 2013!

I’m never surprised when government acts very slowly. But it has gotten beyond that now with the FDA’s pharmaceutical social media guidance. As Ogilvy’s Rohit Bhargava appropriately notes in the headline for this piece, the FDA just doesn’t appear to be that into providing guidance on social media.

Bhargava, citing an FDA document that outlines the agency’s priorities for 2011-2015, reports that a social media guidance, originally expected to be released by the end of last year, now likely won’t be released until at least 2013. Not for another two years. Even if the FDA actually releases a guidance that year (yeah, right), it will be almost four years after it held its public hearing on social media. It will also be almost 10 years after the debut of Facebook, seven years after the debut of Twitter, and even longer after message boards, blogs and ratings sites became available to the masses.

By then, the FDA will be way behind the times on this technology.

Pharmaceutical companies should probably give up waiting for FDA guidance at this point, if they haven’t already. It’s clear that they need to participate in social media. So they should just develop their social media plan and policies as best as they can using existing DDMAC guidelines. Use common sense and pay attention to when the FDA flags other pharmaceutical companies for violating DDMAC guidelines with social media, so you can learn from others’ mistakes.

It’s by no means an ideal way to go into social media. But the FDA clearly doesn’t care enough about this to publish a guidance anytime soon. Pharmaceutical companies still waiting can’t wait any longer. Just do the best you can with what you have.




5 Responses to FDA social media guidance delayed again….until 2013!

  1. Carmen says:

    What the FDA has consistently done is err on the side of caution when interpreting its regulations in both the clinical research and commercial sides of the drug arena. Some see this as an invitation to jump off the deep end of the pool. If pharmaceutical companies truly take the FDA’s directional push to heart, then they will find social media a shallower pool than they thought. Convey the risks and the benefits of a commercial drug in providing a fair representation of the product, no matter where you broadcast that message. On the clinical side of the fence, if you choose to engage in social media (I prefer supporting clinical sites in this rather than pharma), know that every message must have IRB approval when advancing a clinical research study. Being overly cautious is not something to be abhorred. It is an opportunity to be thoughtful in a very patient-centered manner.

    • Joshua Brett says:

      Certainly pharma needs to be cautious and patient-centered. But having an FDA guidance would help social media accomplish that. And it’s not like the FDA hasn’t had time already – their public meeting on social media was in November 2009. There’s being cautious, and then there’s dragging your feet.

  2. Krista says:

    What a bummer but not a surprise either. I guess those in the pharma comm/marketing field must be used to this by now and have let the cynicism set in.

    You make a good point that by pushing this topic back a few years, it’s likely that social media technology will change by then as well. Perhaps it’s too much to ask of a federal agency to keep up with the modern world, but I agree that pharma should use the guidance on communications available and take a few risks in attempting to move to where the conversations are taking place.

  3. Semantelli says:

    As long as you ensure internal AE and REMS policies are followed, nothing should prevent pharma companies from listening to or engaging in social media. Social media is just another channel (This is what FDA said in the last hearing).

    We are seeing significant up-tick in customer interest ever since we released our “compliance ready” social media platform. Companies are taking the next steps to integrate our platform into internal AE/REMS processes so that there are no issues of compliance when it comes to exploiting the power of social media. Engage your Compliance! Make sure they are comfortable with the platform you are using. Things will fall in place. Consider social media as just another digital channel.

    Siva Nadarajah
    VP, Product Strategy and Development
    Semantelli Corp.
    “Compliance Ready, Life Sciences Specific Social Media Platform enhancing CRM, Market Research, Drug Discovery and Competitive Intelligence”

  4. GxP Perspectives says:

    The one area of real concern for me is recruiting for clinical trials using social media. Carmen, on the first comment above, says that everything should go through an IRB before advancing a research study may be hard to enforce. I’ve received inquiries about whether a patient can blog about a clinical trial. There are no regulations regarding patient/subject’s discussing clinical trials but without FDA guidance we won’t know where to draw the line.

    Carl Anderson

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