Over the past three years, nanotechnology has gained prominence on the US Food and Drug Administration's regulatory agenda.
The prospect that very tiny materials may yield more effective, less toxic, high-quality medicines has generated great enthusiasm
among scientists and manufacturers. Some drugs that incorporate nanomaterials are already on the market.
Nanotechnology will be used in many products that come across the FDA's door, according to FDA Senior Scientist Richard Canady.
The agency's challenge, Canady explained at an FDA public meeting on nanotechnology in September, is to determine whether
products incorporating small-size particles pose new hazards and thus require new regulatory and testing policies. Uncertainties
about how nanoscale materials may affect the human body and the environment has prompted calls for added analysis of possible
toxicities and scrutiny of unanticipated effects. A related issue is whether new requirements are needed for all nanomaterials,
or for certain subgroups of products using this technology.
An FDA task force was formed in 2006 to address the need for stricter nanotech product regulation and held a public meeting
on the issue that year. This led to a task force report in July 2007 outlining the scientific and regulatory challenges for
FDA oversight of the expanding nanotech world. The report recommended that the FDA evaluate the adequacy of testing approaches
to ensure the safety, efficacy, and quality of nanoscale materials in regulated products. The task force noted the need for
new data characterization methods, standards for nanoscale materials, and a better understanding of how nanomaterials relate
to one another. The panel also emphasized that the FDA should build its in-house expertise to ensure it can keep up with new
scientific developments in this field, and that FDA reviewers should be better informed by manufacturers on what is known
about a nanoproduct and what analysis has been done.
NO NEW REGULATIONS
The report stopped short, however, of recommending new regulatory action—instead it supported efforts to address disclosure
and data issues on a product-by-product basis. The FDA may not need added authority to ensure the safety of nanomaterials
in drugs, biologics, and other medical products that already require premarket review; here it may suffice for the agency
to issue guidance on how and when sponsors should identify particle size in submissions.
Former FDA Official Michael Taylor, working with the Project on Emerging Nanotechnologies at the Woodrow Wilson International
Center, says that the agency may need added legislative authority to obtain safety information on products with nanomaterials
that receive less FDA oversight. At a nanotechnology conference in February sponsored by the Food and Drug Law Institute,
Taylor warned that a safety problem involving a product with nanotech material not subject to premarket review "will set back
public confidence and acceptance of nanotech products" and block market access for other products.
The nanotechnology task force's main recommendation is that the FDA develop guidance to help manufacturers understand what
testing and disclosure is appropriate for nanotech products. Because nanomaterials have physical, chemical, and biological
properties that differ from conventional substances, different biological activity may result, and new testing procedures
may be required. Nanotechnology may open the door to new therapies with enhanced absorption and distribution, but these properties
also raise the prospect of increased harm from toxic reactions.
The first order of business for the FDA is to define nanotechnology for the purposes of medical product regulation. The FDA
needs to clarify what it considers nanoscale, how manufacturers should identify particle size in regulated products, and what
kind of data are needed to ensure product safety. Such assessment can indicate when the FDA may need to mandate premarket
notification for products using nanotechnology and whether the agency needs a specific regulatory framework to deal with nanotechnology.
A related issue is whether additional preclinical safety assessment is needed to evaluate toxicities in experimental drugs
with nanomaterials to predict injury to organ systems or other safety problems.
Another important topic is to what extent labeling should be revised to include nanotech information to be truthful and not
misleading. So far, the FDA has not required manufacturers to revise product labels to reference nanomaterials. Nor has the
agency regarded products that are reformulated to contain nanomaterials as new products that need to be retested and re-evaluated.