FDA Commissioner Endorses the Use of Biomarkers in Drug Evaluation - June 2003

In a recent interview published in the Boston Globe, FDA Commissioner Dr. Mark McClellan explicitly endorsed the use of biomarkers in the evaluation of pharmaceuticals.  Commenting on the expanded use of biomarkers in the setting of drugs intended to treat diabetes and obesity, Dr. McClellan stated that the agency is asking ''[a]re there valid biomarkers, valid indicators, that we could observe early on, that are highly predictive of clinical benefits that could take years to observe?''

(Download complete text of this Boston Globe article in .pdf)