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FDA's Mission - The mission of the Food and Drug Administration is, in part, to ensure that the drugs, drug delivery systems, cosmetics, medical devices, vaccines, and food products reaching the marketplace are safe and effective. Figure 1 displays the breadth of products regulated by the FDA. These products represent about 20 percent of consumer purchases in the domestic market. Another measure of the impact of FDA's mission is its regulation of about $50 billion per year of medical sector R&D.
Risk Management -- The FDA paradigm for regulation of these products is based on the concepts of "risk management", i.e. risk identification, risk analysis, and risk control. To implement risk management for nanotechnology products, we must acknowledge that the cells and molecules with which FDAers work every day are "nano" in size. In particular, every degradable medical device or injectable pharmaceutical generates particulates that pass through this size range during the processes of their absorption by the body. FDA has not experienced an adverse reaction related to the "nano" size of resorbable drug or medical device products.
FDA regulates on a "product-by-product" basis. Although the several pieces of enabling legislation have established several formalisms for regulation with different names for each product type, they all basically fall into three categories: Premarket Approval, Premarket "Acceptance" and Post Market Surveillance.
Coordination of Policy with Other Government Agencies -- Within FDA, the Office of Science and Health Coordination (OC/OSHC), coordinates regular discussions on nanotechnology among the major experts from every organizational entity within the Agency. In addition the Centers within FDA, e.g. Drugs and Medical Devices, have organized similar regular discussion groups. The purpose of these meetings is to share experiences with the review of the products, insure that each Center is aware of product guidance that may be developing elsewhere within the Agency, and generally educate staff and policy makers about nanotechnology. Safety issues are identified and studied.
In a similar manner, FDA coordinates knowledge and policy with the other US Government agencies as a member of the Nanoscale Science and Engineering Technology (NSET) Subcommittee of the National Science and Technology Council (NSTC) Committee on Technology. Also, FDA and NIOSH co-chair the NSET Working Group on Nanomaterials Environmental and Health Implications (NEHI) to define new test methods/protocols to define safety of these products. Finally, FDA is a direct contributor to the evaluations of the toxicity of materials supported by the NIEHS and the National Toxicology Program (NTP).
Current Issues in Nanotechnology - There are several issues under discussion in various forums related to the FDA's regulation of nanotechnology products.
FDA expects many nanotechnology products that we regulate to span the regulatory boundaries between pharmaceuticals, medical devices and biologicals. These will be regulated as "Combination Products" for which the regulatory pathway has been established by statute. In such cases, FDA will determine the "primary" mode of action of the product. This decision will determine the regulatory framework for the product, i.e. a drug, medical device or biological product. The product application will be managed by the appropriate FDA Center with consultations from the other Centers. It is valuable to repeat here that FDA has traditionally regulated many products with particulate materials in this size range. FDA believes that the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we will regulate. Particle size is not the issue. As new toxicological risks that derive from the new materials and/or new conformations of existing materials are identified, new tests will be required.
FDA regulates products, not technology. FDA, for example, regulates very few materials but many types of products. This will affect the stage at which the FDA becomes engaged in the regulation of nanotechnology and when, in the process, regulation takes effect. In addition, FDA regulates only to the "claims" made by the product sponsor. If the manufacturer makes no nanotechnology claims regarding the manufacture or performance of the product, FDA may be unaware at the time that the product is in the review and approval process that nanotechnology is being employed. Within this issue is embedded the definition of nanotechnology. It is quite likely that new therapeutic benefits are being derived from products that are smaller than their traditional form but fall above the 100 nm size-range limit of nanotechnology.
Finally, FDA has only limited authority over some potentially high-risk products, e.g. cosmetics. As we noted earlier in this discussion, many products are regulated only if they cause adverse health-related events in use. To date there have been comparatively few resources available to assess the risks of these products. Other government agencies have different missions with regards to nanotechnology, e.g. to solve environmental problems, improve technology to address disease, etc. Few resources currently exist to assess the risks that would derive to the general population from the wide-scale deployment of nanotechnology products.