Wounded or Dead? FDA Social Media Guidance

Author:

Correction issued 01/11/11 in response to comments by Jeff Chester from CDD.

At first glance, I thought the FTC interactive marketing complaint was about protecting patient privacy.  When I read the details, the FTC complaint by Center for Digital Democracy, US PIRG and others alleging bad behavior by pharma and naming such luminary companies as Google, Yahoo, Microsoft, AOL and WebMD has one very clear statement buried in the middle of their press release:

“Before the FDA acts, it should await an investigation and a report by the FTC.”

And, then, innocuously buried at the very bottom:

“…which was also sent to Dr. Margaret Hamburg of the FDA…”

Translation:   FDA, please stop the presses on the long-awaited FDA guidance on social media purported to be released later this month.

The FDA is finally poised to act and provide industry with clear guidance so we have a clear set of expectations to meet.  Medical device and pharma want to know what the expectations are and to do the right thing for patients and the public. If tweets publish every minute, certainly FDA could be expected to update and revise their guidance annually in response to changing conditions and technology.

FDA held their first hearings on the internet and advertising in 1996.  Yes, 1996.  And, nothing happened.  Then late last year, the FDA held more hearings/town hall sessions with a five-month written comment period ending in February 2010.  Jeff Chester from CDD kindly provided some insight around their initial comments to FDA as well as their FTC complaint:

“The Center for Digital Democracy filed comments in the FDA’s social media proceeding last Feb, raising many of the issues addressed in the recent FTC complaint. Pharma and health marketers have failed to engage in “due diligence” in addressing the major privacy and consumer protection issues intrinsic to social/interactive medical marketing. For our FDA docket comments, see:http://www.democraticmedia.org/online-drug-marketing
The FDA needs to proceed very cautiously, esp as policymakers and public learn more about unfair and deceptive online health and drug marketing practices.”

On the eve of real guidance from the FDA to industry, consumer watchdog groups, undoubtedly trying to the right thing and protect public interests, issued this carefully crafted 144-page missive  to require the FDA to take them seriously.

While their concerns are important to address, they need time for the FTC to review the complaint, chose a course of action, conduct their investigations, and issue reports.  Then, the FDA can create a new guidance, proffer for public comment and issue a final document.  Let’s have FDA throw their first stake in the ground of social media now and provide a directional arrow.

I hope the FDA and Margaret Hamburg stand strong and move forward for patients, for industry and because 14 years is more than enough time to spend on one guidance document.

If we waited 14 years to outline rules and expectations to our children, I can only imagine what their interpretations, however well-meaning, might be.

Do you think we should wait a few more years for FDA guidance on social media and internet promotion?  What would the effect be on industry?  Patients?  Perception of FDA?

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6 responses to “Wounded or Dead? FDA Social Media Guidance

  1. The Center for Digital Democracy filed comments in the FDA’s social media proceeding last Feb, raising many of the issues addressed in the recent FTC complaint. Pharma and health marketers have failed to engage in “due diligence” in addressing the major privacy and consumer protection issues intrinsic to social/interactive medical marketing. For our FDA docket comments, see:http://www.democraticmedia.org/online-drug-marketing
    The FDA needs to proceed very cautiously, esp as policymakers and public learn more about unfair and deceptive online health and drug marketing practices.

  2. Maureen,

    I think that FDA’s plans for this much awaited guidance, however stalled they may already be with the flurry of comments in the blogosphere over social media and its continuously changing landscape, should not be further stalled by the new FTC complaint by CDD, US PIRG. The reason for this lies in the sentence before the one you mention in your very provocative blog post “Pharma and other health online marketers are pressing the FDA for new rules that would allow them to expand digital and social media advertising.” I doubt FDA is planning to allow Pharma and other health online marketers to “expand” digital and social media advertising. If anything, the guidance will document concretely (in my opinion) that FDA plans to apply current good promotions regulations to social media promotions. Judging by their “Presenting Risk Information in Prescription and Drug and Medical Device Promotion” issued May 2009, I think this new guidance will be detailed enough. In any case, this is a restriction or contraction and not expansion. Based on this premise, I think that the CDD complaint is sufficient for FDA to gain the gist of what they want addressed so that FDA can flesh out some of those details; without having to wait for the investigation to be completed and a report issued by the FTC. Just my two cents, but with inflation it is more like 3 cents.

    Elsa

  3. I agree with JB in that the document won’t provide too much direction outside of common sense. There’s no way it could single out tweets or any one particular technology – just general guidelines.

    • JB and FDAzilla,

      Clearly you are both correct in that FDA guidances are standards and guidelines, not hard and fast rules. However, their Good Reprints Practices guidance which was reasonably clear as to appropriate structure–if not the “how tos”. And, the FDA believes that the rules already exist based on the flurry of warning letters in 2010 around internet and social media advertising. What effect, if any, do you think this FTC complaint may have on the timing of the purported forthcoming internet/advertising guidance?

      Maureen

  4. Excellent post and just what I was thinking. Keep up the good work.

  5. Anyone expecting the FDA’s “guidance” to amount to anything significant – if it ever comes at all – is naive. It’ll be vague and unconvincing, because to do otherwise would require the FDA cede some of its power. And we all know that government bureaucrats cherish their power.

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