Now that the human genome has been sequenced, the challenge ahead is
to translate the information into clinical utility. Enter the field of pharmacogenomics—where
information from individuals' DNA sequence variations is used to tailor drug
treatments for patients—and the Food and Drug Administration (FDA).
The FDA has now issued a draft of a guidance document for drug companies
that encourages them to conduct pharmacogenomic tests during drug development
and to submit resulting data to the agency (http://www.fda.gov/cder/guidance/5900dft.pdf). The goal is to promote research that fine-tunes therapies so that
each patient gets as much benefit as possible with the fewest adverse effects.
Hampton T. FDA Seeks Genome-Based Drug Data. JAMA. 2004;291(1):32-33. doi:10.1001/jama.291.1.32