One Small Step for FDA...
This article was originally published in RPM Report
FDA is building a knowledge base in nanotechnology and testing its current regulatory procedures. But adapting to the new field could stress the agency's already tight resources and may damage its fragile credibility with the public.
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When Mark McClellan became FDA commissioner in late 2002, he brought with him a cadre of like-minded managers and policy advisors. Many were economists; all were advocates for private-sector innovation. Most have departed from FDA. Their departures may have some short-term political benefits for the agency; but they leave a legacy of economic interest in the way FDA works and affects society.
The burgeoning field of nanotechnology is creating hope as well as anxiety in the healthcare industry as researchers look for the best way to use the technology and the FDA grapples to create a policy for regulating products that incorporate the futuristic micro-miniature science. In health care, early focus has been on infection control products.
The pharmaceutical industry and FDA are getting ready for a fight-and for once they are on the same side. They want Congress to reauthorize the Prescription Drug User Fee Act quickly and cleanly-without tacking on other reforms to FDA's drug regulations. They probably won't get their wish.