WikiLeaks, Transparency, and the FDA

Anyone not know the name of Julian Assange, founder of Wikileaks?  Under the guise of “transparency” and “revealing suppressed and censored injustices”, Assange has opened up hundreds of thousands of documents, some of which, the Pentagon claims, have provided dangerous info to enemies of the U.S. “damaged operations”.  I’ll leave the debate on Assange’s motives to others; here I want to discuss  transparency and the FDA.

Transparency is a word that has lost its meaning with overuse.   Especially with the advent of social media, we now have unparalleled access to learn more about our friends, favorite celebrities, and even corporate entities.

I’m in favor of appropriate transparency.  I believe that transparency democratizes information and enables collaboration.  When people of different stripes within the organization can stir the pot with a larger set of data, silos are broken and innovation can occur.  As our world gets more complex, a broader set of voices at the table is critical to finding the best, most creative solution.

Do we want the FDA to be more transparent? Yes.  We’d like to know how decisions are made, we’d like to know more about who the decision-makers are.  We’d like more consistent guidance about what to expect when they inspect our facilities.  We’d like their data to be in a more usable format (what’s with all the PDFs?).  Think about how much market capitalization hangs in the balance when an FDA panel decides whether or not a drug is approved.  Think about the number of company manhours it takes to address one stinkin’ 483 (we’ve heard from one company that this number is in the realm of $250,000).  To understand just a little bit more about how the FDA operates is extremely valuable.  It’s similar to why NFL teams watch so much film of opposing teams – to gain those small, tactical advantages that pay off exponentially over time.  The “film” we have is essentially the FDA website and all the info they provide via FOIA.

Let’s also credit the FDA – they have taken a ton of strides towards more transparency.  For one, they’ve started their FDA transparency blog, which has real, meaningful comments (in comparison, the USDA blog rarely has any comments at all).  The FDA also has a hub webpage of resources around transparency and also a page provides FDA web traffic, most popular content, and number of comments. Though a little late to the game, they’ve got a Facebook page with 2,500+ fans (I think this will be 10,000+ in a year).  And in my interactions with their FOIA team, they have been professional, responsive, and actually faster than you might expect.

But remember that transparency itself is messy and complex, and as such, it’s costly.  It takes time – a lot of time – to decide how to best communicate the mountains of information that’s available.  Figuring out and communicating the context is just as important as the information itself.

On the board I’ve served on in the past, I was constantly amazed at how much (and sometimes how little) time was spent determining how to communicate our decisions.  Decisions that take hours to make require time to be communicated well.  If not, our messaging would inevitably get hijacked by various stakeholders, bending it to whatever agenda they had.  For the FDA, add the complexity that their stakeholders are likely trying to influence the decisions as they happen real-time. (plus, one stakeholder pays their salaries.)

So, of course, we want more transparency from the FDA.  We want more and better intelligence on the FDA (which is the very premise of our company).   But if you were them, would you add more communications people to discuss decisions, or add more investigators/scientists to make better (and more) decisions?  My vote would be for the latter.

And just in case anyone is wondering, Wikileaks really didn’t impact the FDA, though it did reveal a list of vulnerable vaccine facilities.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

One thought on “WikiLeaks, Transparency, and the FDA

  1. anonymous

    Why can’t they work more towards communicating HOW they make decisions vs. just making MORE decisions? The more everyone understands how their decisions are made, the easier it is for them it will be to make decisions over time.

    Reply

Leave a Reply

Your email address will not be published. Required fields are marked *