Tuesday, March 17, 2009

FDA's Answer to ePharma Marketing Guidelines: "circles and arrows and a paragraph on the back"

Today, Mark Senak (Eye For FDA) posted a podcast interview with Dr. Jean Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development (see "A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0").

This was the second time in one week that the FDA had the "bully pulpit" and the ears of ePharma marketers. The first was at CBI's eMarketing conference in Princeton, NJ, where Sanjay Koyani, Director of FDA Web Communications, gave a keynote presentation, which will be summarized in the March issue of Pharma Marketing News.

On both occasions pharma eMarketers had their ears perked up to hear what the agency had to say about regulation of pharmaceutical marketing on the Web and especially on social networking sites.

On both occasions, we were disappointed.

Regarding the keynote presentation, ePharma Pioneer Club member Jonathan Richman had this to say: "It was the FDA showing all the great things that social media can do (which everyone in attendance knew already), but completely ignored the elephant in the room, which was the question: How can we do it and not get into trouble?"

Mark Senak also was rebuffed in his attempts to get some actionable information out of Dr. Ah Kang. "There was no expectation, of course, that the FDA was going to issue a guidance in the context of a podcast," said Senak, "but it did seem important to start getting some definition to the environment where there has largely been only speculation."

Mark posed a scenario to Dr. Ah Kang that I thought was odd. It addressed what Mark said was "the real fear among many companies that if they generate and post original materials that they may later be changed by others." I've never heard that one before and it's a trivial concern compared to pharma's fear of adverse reporting obligations.

Dr. Ah Kang spent the last 4-5 minutes going over the details for submission of ALL promotions -- including Web ones -- produced by pharma for so-called "pre-approval" -- actually, "advisory comments" -- by the FDA. She said: Go to the FDA website, look over the org chart, find the right division, the right "docket," the reviewer responsible for the docket, click on the submission information link, and make sure to put together the package as indicated. Be sure to include a cover letter, all your promotional materials, annotate the materials (ie, with "circles and arrows and a paragraph on the back of each one"), include references. highlight and annotate those references (more circles and arrows and paragraphs), include a PI, etc. Got a problem? Call the FDA's main number!

But whatever you do, don't leave your name on an envelope in the bottom of that half-ton pile!


  1. John,

    Let me just say first, your taste in music is hurting your credibility. At least with me anyway, in case you care, which you probably don't, but you should.

    It seems to me that our expectations once again are too high when it comes to FDA guidance (or even insight). Industry, and its creative partners, need to understand that FDA's mission is to protect and enhance the public health. Maybe they'll surprise me, but I think FDA has little incentive, and plenty of disincentive for creating a web 2.0 guidance document, and opening the faucet to a growth of unintended consequences. For example, there's plenty of remorse in Washington for FDA's DTC guidance(s) and what they have led to. Rightly or wrongly, DTC advertising (TV in particular) is tied up like a pinata ever time there is a drug controversy. Never mind the fact that drug advertising claims (even most of the violative ones) are, by and large, far better substantiated compared to any other advertised product on TV.

    Without a doubt I believe that FDA has to modernize its approach, but we need to adjust our expectations and take it one example at a time. What is web 2.0 anyway? Is it a blog? Is it a chatroom? Is it a youtube video? Is it a newsfeed? Is it a conventional website? Is it a banner ad? Is it a Twitter entry? Is it a podcast? Is it an iPhone app? A widget? Is it a website or blog comment?

    Each one of these things creates unique regulatory (and other) issues, for which a guidance document would ordinarily have to be very general in order to address all of these issues (limiting its utility) or it will have to limit itself to individual issues (for which its usefulness will be limited to individual issues). Defining scope is critical.

    Again, FDA's mission is to protect and enhance the public health. It may be that we have to do a better job of providing evidence and examples of how new media (in use by drug companies) actually enhances their mission rather than creating another enforcement problem (for which FDA will be disproportionately blamed). Jean Ah should be applauded for making herself available, even if she fell far short of our hopes, which should have been expected. What Jean Ah talked about that will be an inevitable part of any guidance or enforcement approach is the chain of influence for any media item. "by or ON BEHALF"

    Of course, you're playing your part. Take any progress you can get.

    I just don't like your taste in music. I might have rambled less if you chose something like "Won't Get Fooled Again" or "The Village Green Preservation Society"

  2. John,

    Thanks for your comment, but don't look at this as representative of my musical preference. Her comments just reminded me of the lyrics to this song, which was as much a part of my youth as hip hop is today among the kids of my son's age. In the future, hip hop will bring back memories to them even if hip hop was NOT their favorite music!

    I must say, however, that I was more a fan of the father than of the son.


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