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

Executive Summary

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.

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The Agency that Cries Wolf

FDA is being more proactive about issuing safety warnings. But, as GSK's experience with Advair shows, what looks like bad news to Wall Street may not matter as much to physicians. FDA is well aware of the limitations of its risk communication techniques, but for now the agency is commited to transparency.

Hurry Up and Wait: The Slowdown in Accelerated Approvals

Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.

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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