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News & Analysis | REG•WATCH Blog | Press Room
Tuesday, October 10, 2006
Is FDA Ready for Nanotechnology?
While nanotechnology could provide some exciting innovations, its impact on people is still largely unknown. As we pointed out last year, some scientists believe nanotechnology could pose risks similar to ultrafine particles released through combustion and welding, which are known to cause a range of health problems that include respiratory and cardiac ailments. But while scientists are still investigating the health effects of nanoparticles, industry is already rushing to get new nanotech products on the market.
Now a new report by the Pew Charitable Trusts in partnership and the Wilson Center for International Scholars says FDA may be ill-equipped to regulate this emerging field. With an ever-shrinking budget and ambiguous legal authority, FDA may not be able to properly evaluate new nanotechnology products before they reach consumers.
Gaps exist in FDA’s legal tool kit. FDA implements a venerable old consumer protection law, the Federal Food, Drug and Cosmetic (FDC) Act, that has stood the test of time in many respects and has retained its resilience through significant amendments since first being enacted in 1938. Nanotechnology does reveal gaps in FDA’s legal tool kit. While there is not a need to start from scratch in providing FDA the legal tools it require to regulate the products of nanotechnology, those gaps do need to be filled if FDA is to provide the oversight people expect. The report analyzes the FDC Act with nanotechnology in mind, identifies gaps, and recommends ways to close them.
FDA lacks necessary resources. The larger issue affecting FDA’s readiness for nanotechnology is resources. For the past decade or more, FDA’s resource base and overall capacity have been eroded by the pressure of increasing demands and costs of doing business coupled with the failure of Congress and successive administrations to adequately fund even base operations. Just to be able to do what it was doing in 1996 and continue the new activities mandated for it since then, FDA’s 2006 budget would have to be 49% greater than it is. Under the President’s proposed 2007 budget for FDA, the funding gap between responsibilities and capacity will grow again, to 56%. This harsh budget reality is a real threat to FDA’s ability to effectively oversee nanotechnology. It means among other things that FDA lacks the resources it needs to build its own expertise, to develop the safety-testing protocols and detection methods needed to evaluate new nanotechnology products, to conduct its own risk research, to gather the necessary premarket data required to get ahead of commercialization and to oversee products after they have entered the market.
FDA held its first major meeting on nanotechnology Tuesday.
Posted by Genevieve Smith
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