FDA chief speaks at Critical Path conference

Speaking at a conference on the Critical Path (Marketletters passim) hosted by the New York, USA-based think-tank the Manhattan Institute, US Food and Drug Administration Acting Commisioner Andrew von Eschenbach told his audience that medicine in the 21st century would need to be "personalized, predictive and participatory."

Dr von Eschenbach, whose appointment on a permanent basis to the post of FDA Commissioner is presently under review in the US Senate, spoke of the need for the agency to evolve in a collaborative direction. In particular, he noted, the FDA must accept that a one-size-fits-all regulatory regime is inappropriate in an age where new drugs are designed to target smaller groups of patients.

At the conference, a report titled: Prescription for Progress, the Critical Path to Drug Development, was launched. The study examined the methods employed by the FDA to evaluate clinical trial data and found that "the biopharmaceutical industry can bring new medicines to market in a faster, safer and less expensive way than current government and industry policy allows." A panel of 25 experts was assembled from the drug industry, government and the scientific community to consider the direction that the FDA should take in the light of the Critial Path program.