FDA Thinks Small: Next Steps for Nanotech

When it comes to drug development, the Food & Drug Administration is starting to think small. Really small.

Nanotechnology—the manipulation of matter on the scale of a billionth of a meter—has gotten the attention of FDA regulators. And while nanotech has been mostly used for cosmetics and OTC drugs like high-tech sunscreens, the science is starting to move in the direction of pharmaceutical and biotechnology applications.

As Ellen Licking wrote in a recent issue of START UP, there are a handful of nano-based prescription drug products out on the market, like the aprepitant nanocrystals Merck markets as the antiemetic Emend, and the albumin-coated molecules used in Abraxis Biosciences’ breast cancer drug Abraxane.

And while none of the marketed nano drug products are exactly blockbusters, there are a few drug delivery companies with dreams to change all that by producing next-generation, “me-better” therapies that are safer or more efficacious than existing products. These young upstarts include BIND Biosciences, Tempo Pharmaceuticals and Liquidia Technologies.

Those invested in nanotech have great expectations for the science. Noubar Afeyan, PhD, a managing director with the Boston-based VC firm Flagship Ventures, told START-UP that nanotechnology is a “whole new way of thinking about designing a drug…that hasn’t been available before.” And talk about bullish: David Sarphie, PhD, CEO of Bio Nano Consulting, predicts that by 2015 nanotechnology will play a critical role in the delivery process or development of up to 60% of biopharma products.

Regardless of whether one buys into the nanotechnology hype, FDA sees it as significant enough to take a closer look. An internal task force released a report on nanotech last year, the findings of which will be discussed September 8 at the latest in a series of public meetings on nanotech-y issues. Topics for discussion will include:

(1) The type of information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials and;

(2) The circumstances under which a product's regulatory status might change due to the presence or use of nanoscale materials (for example, making a device no longer exempt from 510(k) submission requirements).

Expect some controversy at the meeting. Like other new-tech areas like genetically modified foods, not everyone is thrilled about the prospects for nanotechnology. Do a Google search of “nanotechnology” and “safe,” and you’ll come up with a whole host of organizations that question whether FDA should be keeping tighter control over nanotech.

But there is some concern about whether FDA even has the authority and resources to regulate nanotechnology. Plus, nanotechnology extends into other sectors, like clothing and consumer goods, which raises still more questions. If the agency can regulate some nano products, but not others, will that ultimately damage the prospects for the entire science?

Those questions certainly won’t be resolved anytime soon, but given the interest in really, really small things—as well as new ways to improve upon existing products—the meeting is worth checking out. We'll certainly be there.