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Forging a Path for Pharmacogenomics at the FDA

Executive Summary

The FDA is now sorting through public comments on draft guidance the agency issued recently, to encourage drug developers to voluntarily share pharmacogenomic data with it.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.

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Pharmacogenomics: Promises and Problems

So far, pharmacogenomics, the study of the effects of an individual's genetic makeup on their response to drugs, has not produced the hoped-for revolution in the pharmaceutical industry, due primarily to lagging approvals and the high cost of molecular testing. Nevertheless, the promise of personalized medicine is very real, and several exciting products have received FDA approval.

A Little Knowledge: The FDA's Public Approach to Safety

The FDA's loudest critics on the safety issue have changed how FDA works-particularly in its far more public sharing of risk information. In a series of four interviews with FDA experts we explore the implications of these and other changes to the FDA's approach to safety. But one summary point: instead of trying to defend its record against an ever-increasing safety standard, the FDA--and some companies, too--are trying to teach consumers that all drugs have risks by informing them directly and frequently and thereby inoculate them against the more extreme requirements of the product-safety lobby.

The Outlook for Pharmacogenomics Testing in Primary Care

The FDA sees pharmacogenomics as a key tool for optimizing both the development and clinical utility of drugs. But most of the visible examples to date of pharmacogenomics have been in specialty areas like oncology and virology. The Vioxx situation raises an inevitable question as Pharma looks to improve R&D efficiency and clinical utility. What is the role of pharmacogenomics in assessing the safety and efficacy of primary care drugs?

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