It Will Take a Bigger Village to Raise Nano Products

November 2, 2006
Pharmaceutical Technology, Pharmaceutical Technology-11-02-2006, Volume 30, Issue 11

Yet again, FDA's ability to regulate drugs is under fire. At the core of this latest round of scrutiny is whether the agency has the resources to properly control the safety of new nanotech-based drug products.

Yet again, FDA's ability to regulate drugs is under fire. At the core of this latest round of scrutiny is whether the agency has the resources to properly control the safety of new nanotech-based drug products.

Kaylynn Chiarello-Ebner

A recent report* commissioned by the Project on Emerging Nanotechnologies and written by a former FDA deputy commissioner says that holes in FDA's "legal authority" and other "fundamental inadequacies" hinder the agency's ability to determine what risks might be associated with nanotech-based products.

To date, 130 nano-based drugs and delivery systems as well as 125 nano-biomedical devices are under development, a 70% increase since 2005. To make good decisions about these new products, FDA needs more legal authority less than it needs additional staff and more financial resources. With current budget cuts and increased workloads, the report says FDA's 2006 budget would need to grow 49% just to complete the amount of work it had 10 years ago. Increased collaboration, too, will help ensure the safety of new nanotech products. Like the entire industry, FDA is still learning about nanotechnology. Sharing information about nanotech research by moving away from information silos (even among competitors) will benefit the whole field in the long run. FDA also could work across centers—food, cosmetics, pharma, combination products—to collect information.

But as with all new fields of research, convincing the public that new products are safe is another story. To do so, nanotech research must have a strong base in science and be backed by data that lay people can understand. And, most important, hype must be kept in check.

Bringing nanotech drugs to market may take an entire village—and a bigger one. It won't be easy, but doing so will help raise a new generation of safe, effective products.

*M.R. Taylor, Regulating the Products of Nanotechnology: Does FDA Have the Tools is Needs? (Project on Emerging Nano-technologies, Washington, DC, 2006).

Kaylynn Chiarello-Ebner is the managing editor of Pharmaceutical Technology, kchiarello@advanstar.com