Nanotech promises new frontier as FDA decides how to regulate

As the use of nanotechnology in drug delivery becomes ever more prominent in research and clinical stages, it is quickly becoming clear that nano-based therapeutic solutions will drive an increasing presence in the drug market.

Nanotechnology represents a frontier in the delivery of cancer drugs, autoimmune treatments and genetic silencers, among others. And the FDA is making an early effort to make sure the technology is safely and adequately regulated before the market takes full hold. The U.S. authority aims to prevent what is a promising new frontier from becoming a regulatory Wild West.

In an administration FDAVoice blog post late last week, Celia Cruz, a senior reviewer of chemistry, manufacturing and controls at the FDA's Center for Drug Evaluation and Research, wrote about the agency's early approach to managing nanotechnology risk and its plans to make sure the industry is on board. In a risk-management exercise, the administration determined that certain parts of its current review process will work well enough for nanotechnology, but that it also needs to revamp some of its procedures to accommodate the cutting-edge technology and its possible dangers.

Cruz identified these needed areas of improvement as, rather broadly, "increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials." She noted, as well, that the administration "does not make a categorical judgment that nanotechnology is intrinsically safe or harmful. Rather, for nanotechnology-derived and conventionally manufactured products alike, FDA considers the characteristics of the finished product and, as applicable, its safety, effectiveness or other product attributes."

So while the FDA wants to keep its standards consistent, certain properties of nanomaterials must be taken into account--notably, that a substance at the nano-scale can differ greatly from the same material in a larger form. For instance, nano-gold is an important aspect of many new delivery techniques for its ability to infiltrate cells. But that same characteristic has been shown to have dangerous implications in both the body and the surrounding environment.

On its website, the U.S. authority lays out its approach to dealing with nanotechnology in drug delivery, as well as food and cosmetic products. While the general premise is consistent with how the FDA regulates other substances, it takes special care to point out that, yes, this is a new technology, and no, its potential risks are not entirely confirmed.

Now that the bullet points are set, though, there is still a lot of work to do to be ready for the upcoming nanotechnology wave, Cruz points out. This coming January, the administration is holding a workshop to bring together FDA officials, industry leaders and researchers to help brainstorm best practices for the future. -- Michael Gibney (email | Twitter)