While the FDA has taken steps to acquire the scientific expertise necessary for effective regulation of other emerging technologies, the agency has only begun to prepare for the advent of nanotechnology. As of this writing, there have been few conferences, forums, working groups, leveraging activities, or regulatory science projects aimed at increasing agency expertise in nanotechnology. The agency has conceded that, in the context of nanotechnology, there are "now serious gaps between what the agency needs to do and what it can do."99
The FDA will be confronted with complex scientific issues in regulating nanotechnology that are at least as complicated as those raised by the most sophisticated applications of biotechnology. As explained earlier, the agency must make difficult decisions regarding what additional data will be required to approve a therapy that is improved by nanotechnology.
There are several reasons why it may be more difficult for the FDA to maintain scientific expertise in nanotechnology than past and other emerging technologies. First, nanotechnology is unique in that it will touch virtually every aspect of modern medicine. As one scholar put it, "[T]he difference between nanotechnologists and biotechnologists is that the former do not restrict themselves to biological limitations like the latter, and they are much more ambitious about the kinds of accomplishments that they want to achieve."100 Unlike other past and emerging trends in medical products, nanomedical products will be evaluated by every Center at the FDA; often different Centers will be forced to review similar products. For example, CBER will be primarily responsible for evaluating the efficacy and safety of dendrimers in gene therapy while CDER and CDRH will review dendrimers as drug delivery vehicles. This is different from other emerging technologies where a particular center could establish expertise in a particular area of research. Because CBER was handed the responsibility of regulating nearly all biotechnology products, it was able to develop expertise in the area and develop a working relationship with the biotechnology industry. Staff became intimately familiar with products, ongoing research, and industry players while manufacturers became acquainted with the reviewers, procedures, and requirements of CBER. Division of responsibility to enhance expertise may not be possible with nanomedicine, where every Center will be faced with review of nanoproducts.
Second, it may be more difficult for the FDA to acquire staff with an expertise in nanomedicine than other past and emerging technologies. There are still relatively few experts in this burgeoning field. And as the field begins to take flight in the near future, the most qualified scientists will be lured away by the higher salaries and stock options offered by industry.
Finally, the FDA will be forced to address the scientific issues generated by nanotechnology in the midst of other technological changes and a stagnant budget. Attempting to keep pace with the rapid rate of technological change has already stretched the agency's resources and capabilities. Furthermore, the FDA must assume a more prominent role in national security. From drafting guidance documents to hiring appropriate personnel to acquiring the equipment and facilities needed to analyze nanomaterials, adequately preparing for nanomedicine will require a great deal of focus and substantial monetary investment. Nevertheless, the last several years have witnessed the budget shortfalls in the FDA.
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