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Biotech Bottleneck: Can Support From Bush, FDA Speed Things Up?

In February, President Bush announced "major new ground rules" to streamline the regulation of the biotechnology industry. And on the same day, the president's Council on Competitiveness published--under the auspices of the Office of Science and Technology Policy (OSTP)--a policy for all biotech-regulating agencies that set out a "risk-based, scientifically sound approach to the oversight of planned introductions of biotechnology products into the environment." OSTP's risk-based approach means

Scott Veggeberg

In February, President Bush announced "major new ground rules" to streamline the regulation of the biotechnology industry. And on the same day, the president's Council on Competitiveness published--under the auspices of the Office of Science and Technology Policy (OSTP)--a policy for all biotech-regulating agencies that set out a "risk-based, scientifically sound approach to the oversight of planned introductions of biotechnology products into the environment." OSTP's risk-based approach means that biotechnology products, whether used as therapeutics or released into the environment for agricultural or environmental-cleanup purposes, will be regulated like nonbiotech products, solely on the basis of their potential environmental hazard.

On the heels of the Bush administration policy pronouncements on streamlining biotechnology regulation, Food and Drug Administration commissioner David Kessler announced personnel additions that would increase his agency's responsiveness. Kessler said at a March 5 meeting of the Massachusetts Biotechnology Council that he has appointed two new directors and will...

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