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Forging a Path for Pharmacogenomics at the FDA

The FDA is now sorting through public comments on draft guidance the agency issued recently, to encourage drug developers to voluntarily share pharmacogenomic data with it. Companies have some serious concerns that the agency means to address by the summer with the issuance of formal guidelines and the launching of a public forum for discussion about pharmacogenomics.

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...

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