Forging a Path for Pharmacogenomics at the FDA

The FDA wants to encourage drug developers to voluntarily share with it pharmacogenomic data—that is, data linking genes to the way individuals respond or are likely to respond to medicines. Potentially, gene-based tests could minimize adverse drug effects and increase the benefits of treatments. They might also reduce health care costs, by identifying patients who won't be helped by a given drug, or by steering people directly to appropriate medicines.

The agency knows that drug companies have been investigating pharmacogenomic technologies and tests, but it also knows they've been reluctant...