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Washington DC Nano News - A Day with the FDA

By Margaret Glass on September 18, 2008 | Log in to view or post comments

authored by Margaret Glass, ASTC

My overwhelming impression after sitting through a day-long session titled “FDA Nanotechnology Public Meeting” was of the excruciatingly slow pace of the regulatory process, at least as it relates to nanotechnology in the US. In October, 2006, the FDA held an initial public meeting on this same topic. So what has changed between 2006 and 2008? To find out, I looked up the announcement and agenda for the 2006 meeting and followed the process to the present. The October, 2006 meeting was held as a result of the formation of an internal FDA Nanotechnology Task Force formed the previous August. The Task Force was “charged with determining regulatory approaches that would enable the continued development of innovative, safe, and effective FDA-regulated products that use nanoscale material.” As requested by Acting Commissioner of Food and Drugs, Andrew C. von Eschenbach, the Task Force opened a docket and held a public meeting for input on October 10, 2006. In July 2007, the Task Force submitted the initial findings and recommendations of the public meeting to the Commissioner in a report. The Commissioner promptly endorsed the report and its recommendations – and directed the FDA to “issue additional guidance to provide greater predictability of the pathways to market and for ensuring the protection of public health. Please move forward with these recommendations, pursuant to FDA’s good guidance practice (GGP) process (21 CFR § 10.115), as appropriate.” This current public meeting was held to solicit comments on the Task Force report of the first public meeting, which was held to gather input after the creation of the Task Force, which was created after public input called for the FDA to regulate nanomaterials in consumer products…One wonders how long this parade of public meeting collecting the same kind of input can go on. As long ago as May 2006, a coalition including the International Center for Technology Assessment's (ICTA) and Friends of the Earth filed the first legal action on the risks of nanotechnology, a petition to the FDA calling on the agency to regulate nanomaterials in consumer products. "FDA has had the blueprint on how to move forward with nanotechnology pending before it for over two years, wrapped with a bow," said ICTA staff attorney George Kimbrell aftert his latest meeting. "That the agency has failed to act is more of this administration’s anti-science, anti-regulatory political agenda that will pass the buck to the next administration to tackle."    At this point of time – less than two months before the national election – I’d say it’s safe to consider that buck passed.