The Trouble With Transparency

Thursday, June 24, 2010

Get our your buzzword bingo cards, folks... because I'm about to talk about something that only exists in PowerPoint slides. It's the Loch Ness Monster of good government: transparency.

Everyone is in favor of transparency and if you ask them how much transparency they want, the answer is always more. In decades past, we've understood federal transparency projects to be mostly hot air. All heat and no light. The the kind of thing you might put your political appointees in charge of so that they're not in a position to cause any real harm.

But now, apparently, we're serious. Transparency has been rebranded as "open government" and FDA upper management has received orders to begin drinking the Kool-Aid. CDRH has become much more serious about social media. FDA has ruinedupgraded their web site. CDRH honcho Jeffrey Shuren has even taken the transparency show on the road, holding three town hall meetings to find out what the people want.

What has Dr. Shuren learned from the first two of these scheduled meetings? That the approval process is too difficult. That FDA is inconsistent, of course. Oh, and it would be great to have some more transparency too. We could always use more of that.

This reminds me a bit of that joke in Annie Hall: The food at this place is really terrible... and such small portions! The problem isn't that FDA is unaware of what we want, the problem is that what we want doesn't make any sense.

We want greater transparency. On the other hand, we want FDA to be fluid and flexible, nimbly adjusting to the rapidly-shifting trends in medicine and technology. We want them to apply a regulatory standard that is well-matched to the unique requirements of each situation. But transparency and innovation are opposing goals to be held in balance, not checklist features to include in FDA 2.0.

The trouble with transparency is that it carries a far steeper price than some extra federal spending. Increased transparency means decreased flexibility, reduced innovation and longer lead times. Put another way, the main reason we don't already have more transparency is that additional transparency costs all the things we value more highly than transparency.

Consider this: you have a bold, new product that meets an emerging need. It uses the latest in medical research or technology to deliver a previously unobtainable benefit. You approach FDA to discuss how your innovation will be regulated. "Ah, yes" FDA murmurs, "One of those. We're still working on the guidance document for that." You're puzzled, of course, because there is nothing like your invention on the market, but then you ask around and it finally dawns on you. Someone else invented that several years ago and has been waiting in vain for FDA to issue finalized guidance documents and rules about how such products are to be regulated. You're now stuck in regulatory limbo.

This alternate-reality FDA is under strict transparency rules, you see. Everything they do must see the light of day and so they can't regulate one innovative product until they've decided what rules to apply to the entire category. They won't know what rules to apply to the entire set of products until more of them come in. But the field is rapidly evolving, so there are always new things to consider and more study is always warranted.

Full transparency means that the political cost of each decision will soar. That is because each transparent decision could, in effect, constitute a new rule or guidance. The amount of process and debate and speculation that has gone into, say, IVDMIA could become the norm for each new medical innovation. Imagine if the IVDMIA process had to conclude before any multivariate tests were allowed on the market at all. Is that really what we want? 

I suspect not. We want FDA to be nimble. We want them to keep abreast of the rapid developments in medicine and to make a best effort to match each innovation with an appropriate level of regulatory burden. In short, we want them to show a less than total degree of consistency. Despite what we say, we want them to learn and be willing to make mistakes.

Transparency is the enemy of growth and innovation. Sunlight may be the best disinfectant, but too much of it can cause melanoma.

Honestly, none of this is news. This inevitable conflict of interests is the same wall government transparency efforts have hit in the past. When push comes to shove, we don't want to give up the things that greater transparency would actually cost us. We'd rather have some minor adjustments and changes made.

Let's not get our hopes up about transparency this time either. I expect that this, too, shall pass.

 

 

Tags: 510(k), Best Practices, CDRH, FDA, FDA 101, IVDMIA, Industry, Policy

Other Blog Authors

Dave Kern
Steve Gutman
Jo-Ann Gonzales
Deb Morris

Recent Blog Posts

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!