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FDA testing streamlined

Date published: 13/01/2006

The US Food and Drug Administration (FDA) has released new guidelines to make the earlier stages of drug development more efficient. It is hoped the guidelines, published yesterday, will allow pharmaceutical companies to launch fewer tests on drugs with no benefit.

The guidance allows very early exploratory scientific studies in people before Phase I standard safety studies begin. Mike Leavitt, FDA health and human services secretary, said: "Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies.

"The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs." It is also hoped the changes will allow more possible treatments to be examined.

FDA Deputy Commissioner for Operations Dr Janet Woodcock said: "The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad scale distribution. "These requirements are so burdensome for early Phase I studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories."

The guidance also gives medical researchers specific advice about how to safely prepare products for exploratory studies.

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