Pharma need for Critical Path regulator guidance

The requirement by the drug industry for a clear regulatory paradigm is behind the decision of the US Food and Drug Administration to adopt a proactive approach to pharmacogenomics, according to Janet Woodcock, the FDA's Deputy Commissioner, who recently took over the management of the agency's Office of the Chief Medical Officer, having previously served as Deputy Commissioner for Operations. With the publication last year of the agency's Pharmacogenomic Data Submission Guidance, firms have the mechanism to incorporate scientific progress in pharmacogenics into drug development.

Dr Woodcock was interviewed by the Personalized Medicine Coalition, an advocacy group which is backed by the Pharmaceutical Research and Manufacturers of America (PhRMA), for the on-line publicaton, The Age of Personalized Medicine. She described the Critical Path Initiative as having "gotten further in two years than one would have thought possible."

The Critical Path opportunities list was published in March 2006 and was "very well received," Dr Woodcock said, adding that "it has 76 different projects that we feel, if completed, would really enhance drug, device and biological product development in specific areas." She noted that industry or patient groups are "making significant efforts to get collaborations going," although the FDA is finding the analysis of disparate pharmacogenomic data to be difficult.