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FDA to Research Branded Websites on the Interwebz

Guest Blogger

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Last week, FDA announced it would conduct research to better understand how DTC information is presented on branded websites and how it influences consumers’ perception and understanding.

They’re sponsoring three studies to examine how these website elements influence consumer understanding of product benefits and risks:

  1. Risk information on branded sites - including how scrolling of risk information affects comprehension, and the differences when info is presented via paragraph, bulleted list, checklist, highlighted box, or animated spokesperson
  2. Features such as personal testimonial videos and interactive visuals
  3. Links to and citations from external organizations referenced on the homepage

Pharmalot and EyeOnFDA already weighed in on the topic, and here’s the more-than-you-probably-really-want-to-know version of the proposal on the Federal Register.

In case you missed it, DDMAC just delivered results from a TV DTC study at the DTC National conference last month (my wrap-up here). Amie O’Donoghue, Social Science Analyst, DDMAC, presented findings from a four-year study that began in 2007 (yeah — you read that right - it took four years) on the impact and effectiveness of distractions such as supers in DTC TV ads. At the time, I was surprised they weren’t presenting findings from digital studies (now we know - plans were underway). You can peruse those TV findings online here.

FDA/DDMAC is very data-driven. Surrounding the Nov. 2009 hearing, they invited industry to share any market research on digital/social channels to better understand the medium. And my guess is, industry probably didn’t choose to open that door, and/or they don’t have the data FDA sought. So FDA felt it need to (spend our tax dollars to) do their own studies.

I actually very much welcome FDA to study the digital medium. I’ve always been a big advocate of data-driven decisions. And if they study it closely, perhaps then they’ll (hopefully) understand it better. Perhaps they will see that the forced interpretation of their own (non)rules is causing MORE confusion around health information — not the clarity that they seek on behalf of patient safety. Perhaps they will see it’s not as easy as one thinks to decide if a scrolling box vs. a bulleted list vs. a paragraph in a box has more impact. And that it does take time, money, and resources to carefully and thoroughly evaluate these things.

Perhaps the outcomes will provide much-needed clarity. For example, the FDA has issued warning letters for patient testimonial videos in the past (here’s one for Abbott and another for Wyeth/Pfizer). Immediately after these letters were issued, there was a ripple effect of patient testimonial videos being pulled off pharma websites across the industry. Perhaps DDMAC’s new studies will show that, if the videos are done a certain way, then they are fair and balanced and acceptable.

Some industry observers have predicted this will further delay social media guidance. I’m not qualified to predict if it will or won’t and I certainly don’t have an FDA crystal ball. But it does seem like they should have been doing these studies well in advance of the FDA hearing on the Internet and social media, or at least kicked them off sooner so that the results would help drive guidance.

As Mark Senak so eloquently pointed out, we’re nearly 15 years into the Internet and these studies seem a bit late to the party. My question is, where are plans for similar studies into communications via social and mobile channels?

Yes, I’ll be interested to see these results and the impact they have on the way we approach digital DTC. But suffice it to say that I wouldn’t expect any outcomes from this one very soon, despite their stated timeline of completion "anywhere between late 2011 and early 2013."

When will they learn to stop giving themselves deadlines?



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