As the keynote speaker at our recent conference on the Critical Path (graciously sponsored by our think tank confreres at the Manhattan Institute) Dr. Andy von Eschenbach described 21st century medicine as having to be “personalized, predictive, and participatory.”
And the same can be said for the FDA.
The agency must become more personalized in the sense that it can no longer operate under a “one-size fits all” mentality to regulation — particularly (and for example) as relates to clinical trials.
The agency must, similarly, become more predictive. Consider here the three “Bs” — Bayesian Statistics, Biomarkers, and Bioinformatics.
As for participatory, the 21st century FDA must both engage and lead. The agency’s recent rope-a-dope communications strategy has resulted in falling public confidence, increased media strutiny, more intense and self-serving political posturing, and an internal crisis of confidence. Unfair and unearned? You bet. But reality.
Andy spoke about “FDA Evolution.” He reminded the audience that a caterpillar is going to morph into a butterfly — and there’s nothing it can do to prevent that change. So too will the FDA change into something. But, unlike the caterpillar, the FDA can decide what it wants to become and choose how it wants to evolve. But evolve it must. According to Andy, the process must (must!) be a collaborative effort. FDA can neither work nor change in a vacuum.
And at the center of that evolution, said Dr. von Eschenbach, is the Critical Path initiative. This point was eloquently echoed by another conference speaker — Dr. Janet Woodcock.
To pursue Andy’s caterpillar/evolution theme, consider this — We are all crewmembers on board the FDA’s Voyage of the Beagle.
And we must all have a common mission — evolutionary change. It kind of puts “survival of the fittest” into a new context.