After months of missed deadlines, the US Food and Drug Administration this March finally released its Guidance for Industry on when and how drug companies should submit genomics data, and how the agency will evaluate it.
The halting process of composing the guidelines – originally planned for launch in summer 2003 – mirrors the slow realization of pharmacogenomics' much-hyped promise. Understanding the genetics of drug response and toxicity can guide the development of effective, targeted drugs; witness Herceptin, Gleevec, and Erbitux. The FDA recently approved the first automated lab test allowing doctors to test a patient's cytochrome P450 genotype to determine the optimum dosage of certain medications.
Yet the field still is far from the ideal of personalized medicine for all, largely because it's producing massive amounts of information that scientists are still struggling to interpret. Companies have been wary of releasing genomics data, given what it might reveal about ...
