FDA chief: I feel responsible for whole world

"We're moving towards an era where there will no longer be any rare diseases."

"The FDA feels it is responsible not just for the citizens of the US, but the whole world," says US Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach in a first interview with an Israeli newspaper. "We've been working together with other regulatory authorities across the world for some time. The pharmaceutical industry is international and so are diseases."

Addressing the complaints about the acute difficulty and heavy cost that obtaining FDA approval entails, von Eschenbach said, "We're trying to create a much more efficient product approval track. We've changed our philosophy. In the past, the FDA would receive the finished product and then begin the assessment and approval processes. Today we are committed to the entire life cycle of the products we regulate - from initial production to implementation. This is why we're working in cooperation with companies that produce new drugs."

As to the issue of orphaned drugs - drugs for rare diseases that pharmaceutical companies are reluctant to develop because the target group is small - Eschenbach said, "We have an important commitment to promoting orphan drugs, as well drugs used in pediatrics. But I think the real secret is that we're moving towards a new era in drugs. Instead of thinking about the development of drugs for specific diseases, such as prostate or breast cancer, we're beginning to see products for the body's physical mechanisms, and which resolve all the diseases resulting from them. So for instance, a cardiovascular drug can also treat leukemia, and retinal degeneration. We're moving towards an era where there will no longer be rare diseases or orphan drugs. Instead, there'll be drugs that are part of a medical portfolio."

Published by Globes [online], Israel business news - www.globes-online.com - on May 28, 2008

© Copyright of Globes Publisher Itonut (1983) Ltd. 2008

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