Nanotechnology seems to be creeping up on us. The FDA is paying attention.
Earlier this year, the FDA announced plans for a meeting on the topic of nanotechnology. The notice defined it as:
"Nanotechnology is described by the National Nanotechnology Initiative as the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications. Essentially, nanotechnology is a branch of science devoted to the design and production of extremely small matter. " While this is not an "official" definition, it is the one the agency is using.
For purposes of medicine, this tiny technology could be utilized to make new drugs and new methods of drug delivery in humans. In other words, there is a lot of potential for benefit. There are also theoretical and unknown risks.
There are several issues attending the employment of nanotechnology for the FDA to consider, such as
- The likelihood that many of the nanotechnology products that the Agency regulates will be Combination Products (i.e., drug-device, drug-biologic, or device-biologic products).
- Because FDA regulates products based on their statutory classification rather than the technology they employ, FDA’s regulatory consideration of an application involving a nanotechnology product may not occur until well after the initial development of that nanotechnology.
- Because FDA has limited regulatory authority over certain categories of products, the Agency may have limited authority over the use of nanotechnology related to those products. For example, there is no premarket approval of cosmetic products or their ingredients, with the exception of color additives. (from the FDA FAQ on Nanotechnology)
The agency is in the process of gathering material for the generate a guidance about nanotech. However, in the meantime, for communications purposes, the agency would do well to produce a media guide for journalists seeking to write about nanotechnology. Given the fact that nanotech is already making its way into products, it is only a matter of time before more journalists begin to write about it. The agency would do well to do its part to ensure that those doing so, understand it. While FDA has produced FAQs on nanotechnology and other supporting materials, it would be even more useful if these materials were gathered together in a writer’s guide along with a glossary so that misunderstandings are averted.
The FDA announced in April that they would be holding a meeting on nanotechnology, which is at last being held on October 10, 2006 at the NIH campus, Natcher auditorium, and you can register for the conference at the FDA site.
