Nanobiotechnology and the Food and Drug Administration

Abstract

Nanotechnology and nanobiotechnology have the potential toprovide tools for in vitro and in vivo diagnostics for much earlier detection of disease; facilitate targeted drug delivery and regenerative medical applications; supply anti-microbial coatings for implanted medical devices; and enable devices that seek, bind to, and destroy tumor cells. The Food and Drug Administration (FDA), as the gatekeeper to clearance and approval of medical and healthcare products in the United States, will be largely responsible for the oversight of the clinical research, approval and marketing of nanotechnology products for human use. At the present time, nanotechnology products are assessed on a case by case basis using existing regulations without specific categories, requirements or processes applicable to nanotechnology. FDA is reviewing and has approved human drug and medical devices that classify as "nanoproducts" using the established oversight paths for drugs and devices. This approach has provoked debate, with some arguing that nanotechnology warrants its own oversight provisions. A July 2007 report of FDA's Nanotechnology Task Force flagged combination products utilizing nanotechnology as potentially problematic for the agency due to novel issues for regulation relating to scientific and technological features. While the creation of the OCP has resulted in a more collaborative approach to regulating emerging medical products crossing traditional boundaries among drugs, medical devices and biologics, the rapidly developing applications in nanomedicine that merge therapeutic drug delivery, imaging capabilities, and diagnostics may pose the next challenge. Unlike products at the macroscale, properties at the nanoscale and the distinction between chemical and mechanical action are not easily distinguishable or measurable. The challenge for FDA and other federal regulatory agencies grappling with the scope of nanotechnology will be determining whether nanotechnology products warrant additional regulations or whether current oversight can be adapted to the newly emerging capabilities and characteristics exhibited at the nanoscale.