Priorities

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In the wake of the FDA's Part 15 meeting on social media, all eyes are on the horizon to see what is to come.  FDA's Janet Woodcock said at the FDLI Conference this fall that the issue of social media, the Internet and FDA regulation is a "priority" for the agency.  Presumably there will be some sort of draft guidance – that is the FDA's usual method of operation, though there is absolutely no guarantee of that and no one has explicitly said that a guidance is coming.  That is just the assumption.

But for sake of discussion, let's say that there is a draft guidance that is going to be cooked up (that will likely be outdated by the time it is printed, but that is another discussion).  But what would it look like?  What would it tackle first? 

As a Postscript to yesterday's posting "What We Didn't Hear at the FDA's Part 15 Meeting" I would add the issue of priorities.  Not only did we not get a sense of priorities from the FDA, we didn't really hear one from participants either. 

Reviewing the two days' worth of over 70 participations, there were a lot of issues that surfaced in answer to the FDA's five somewhat limited areas of questions posed to the public .  If you were DDMAC, which one would you tackle first?  Would a guidance try to address all of them, or some of them.  Presumably the draft guidance will follow in line with the five question areas.  But again, we can only speculate.

What would you address first?  Links?  Fair balance?  Content?

For me, the priority here is actually public health.  Do I think that public health is threatened in any way by a paid search ad that contains indication language but no risk language, but links one click away to such risk language?  Not at all.  The very notion is laughable.  No one buys a drug based on a paid search advertisement's content.  Not one person.  We don't even need a study to point that out, though the FDA felt compelled to go through the regulatory exercise of issuing the 14 Notice of Violation letters on April 2, 2009 – an action which said a lot, and none of it very good, about the agency's judgment when it comes to priorities. 

Rather, an alarming fact is that while people continue to go to the Internet for information that will help them make important decisions in their treatment and care.  And a primary resource, whether you like it or not, is Wikipedia, because it is so optimized for search it comes up high when you search for information about a particular disease state.  And yet, when one goes through Wikipedia, while there is often content that is indeed accurate and useful, there are also profiles of medical products that are more aged than a toothless dog and bear little, if any, relevance to the use of the medication today.  Yet the authorities of that very information, the manufacturers of the product, are barred from correcting that misinformation by their own regulatory counsel, who is fearful of FDA regulatory action if they do.  And it is that outdated, or perhaps flat out incorrect information, that, unlike the paid search violation, directly threaten the health of individuals who seek out and act upon that information.  (By the way, for medical information, a better resource is probably Medpedia, which has a more formalized editorial process.) 

This is a good example of how FDA reticence to formulate a policy around social media has actually led to the unintended consequence of allowing, if not exacerbating, a public health threat.   And when the agency has chosen to act, (the 14 letters), it is merely acting based on the letter of the law (regulation), not in a way that promotes public health.  That gives one serious pause as we embark on the development of a presumed guidance.

The agency should be encouraged to review the issues raised over the two days' of presentations and to prioritize addressing them by ranking their public health impact.  Margaret Hamburg, FDA's Commissioner, has publicly stated that she wants to return the agency to the status of a protector of public health.  Prioritizing these issues along public health lines, and acting upon them more quickly than through a draft guidance procedure, would be one important step in doing just that. 

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One Response to Priorities

  1. Ellen Hoenig says:

    Mark,
    I think that you raise an excellent point about what should the priorities be for FDA SM policy going forward. Focusing them on patient/public health is a great place to start and perhaps can act as a strategic roadmap…but hopefully, they will not write a 20+ page document like they just issued for communication of patient risk!:-) Enjoy your Thanksgiving.
    Ellen