In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) — Nakissa Sadrieh and Parvaneh Espandiari — published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?”

The article begins with a disclaimer that the authors’ views and opinions are not necessarily those of FDA, and then narrows its specific focus to nano-products regulated by FDA’s Center for Drug Evaluation and Research (‘CDER’) – primarily new drugs and/or drug delivery systems.

To frame the discussion, the authors quote FDA’s informal three-pronged definition of “nanotechnology:”

[the] research and technology or development of products that involve all of the following: the existence of materials or products at the atomic, molecular or macromolecular levels, where at least one dimension that affects the functional behavior of the drug/device product is in the length scale range of approximately 1-100 nanometers; the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and the ability to control or manipulate the product on the atomic scale.

The authors note the efficacy of this definition is currently under discussion within FDA’s CEDAR working group.

The article next addresses the likelihood of new nano-drugs and/or nano-drug delivery devices being treated by FDA as “combination products” (i.e., drug-device, drug-biologic, and device-biologic products), the development of which will be coordinated by FDA’s Office of Combination Products. The authors explain functionally how a nano-based “combination product” might be primarily assigned to one of three (3) FDA Agency Centers for premarket review and regulation based on a primary mode of action analysis (CDER, Center for Biologics Evaluation and Research, or Center for Devices and Radiological Health).

The highlight of the article is the authors’ opinion that existing FDA regulations adequately cover the types of nano-products currently being contemplated for submission as Investigational New Drugs to FDA. The authors note existing pharmaceutical testing includes the areas of pharmacology; safety pharmacology; absorption, distribution, metabolism and excretion; genotoxicity, developmental toxicity; irritation studies; immunotoxicology; carcinogenicity; and other product-specific tests. They conclude this existing preclinical testing is sufficient to detect any possible health risks posed by nano-drugs and/or nano-drug delivery devices.

In an effort to balance their conclusion, the authors then list eight (8) specific nanotechnology questions and eleven (11) safety considerations they believe need to be addressed by CDER. Notably, these considerations include whether ‘nanoparticles [will] gain access to tissues and cells that normally would be bypassed by larger particles,” and “[o]nce nanoparticles enter tissues, how long do they remain there and where do they concentrate.” The authors conclude that FDA may not currently have the ability to adequately address these issues, and propose “much of the currently ongoing research [may not be] focusing properly on the questions that may be most relevant to FDA as a regulatory agency.” The authors note that much of the current nano-testing is in vitro, and that in vivo studies should also be conducted in order to answer the most important questions presented.

The article concluded with the authors’ prediction that “we do not expect that the FDA will be issuing any new guidance to specifically focus on nanotechnology products, as these products will be covered by the existing guidance documents.” . . . and . . . “[i]n the meantime, and based on the available scientific knowledge, nanotechnology products will be handled on a case-by-case basis, as is the case for all other products submitted for review to the FDA.”