Abstract
Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for “drugs” and “devices.” The last major modification to these terms was in 1976, with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by “chemical action.” We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies.
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Notes
The ultimate resolution of how to incorporate new scientific knowledge and new product types into statutory and regulatory systems resides with Congress. Congress often takes many years to act after major scientific changes or advances. The concepts we set forth in this article are directed at the regulatory agencies, which must deal with outdated statutes. However, these concepts could also form the basis for Congressional action to address the impact of new scientific knowledge and new products.
For example, nanoparticle silver coatings on implants are viewed as devices, while nanosphere-based drug delivery systems are considered drugs.
FDA generally does not regulate the practice of medicine. See, for example, 21 USC §396. Also, dietary supplements and certain foods can make health claims without being considered drugs, devices, or biologics. 21 USC §343(r) sets forth some requirements for foods making health claims. For our purposes, these exceptions will not be discussed in any detail.
“New drugs” are defined under 21 U.S.C. §321(p) and, generally speaking, including any new compound or new use of an old compound that came into existence after 1938.
For our purposes, the metabolism element is not relevant. We do point out the, perhaps inappropriate, use of the “and” connector between the “chemical action” clause and the metabolism clause. In general usage, this has been interpreted as meaning “or.”
There was some pending device-specific legislation around the same time as the 1962 drug amendments. Perhaps because of the challenge posed by thalidomide, the drug amendments were passed, but the proposed device amendments languished.
Physicalism is a term that can be traced back to Otto Neurath (2000).
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Acknowledgments
Preparation of this article was supported by National Science Foundation (NSF) grant #0608791, “NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context” (Principle Investigator: S.M. Wolf; Co-PIs: E. Kokkoli, J. Kuzma, J. Paradise, and G. Ramachandran). The views expressed are those of the authors and do not necessarily reflect the views of NSF. The authors wish to extend special thanks to Saurabh Anand for his invaluable assistance in the underlying research and assessment of differing approaches to this issue.
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Koolage, W.J., Hall, R. Chemical action: what is it, and why does it really matter?. J Nanopart Res 13, 1401–1417 (2011). https://doi.org/10.1007/s11051-011-0253-y
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DOI: https://doi.org/10.1007/s11051-011-0253-y