Medical Device Daily

Companies developing products that incorporate nanotechnology know that highlighting nanoscale innovations invites closer regulatory scrutiny.

Still, one of the first drugs approved three years ago, Abraxane for breast cancer, wasn't touted as involving a nanotechnology, but it was — slipping under the radar screen as a reformulation controlled by its particle size. And the watchdog agency Project on Emerging Nanotechnologies (PEN, Washington) says U.S. regulatory authorities such as the FDA, despite the oncoming wave of these "nano-products," are still ill-equipped to actually identify or act on potential safety issues given current resources.

"Major hurdles still stand in the way of the public, industry and government in obtaining a better understanding of the risks posed by nanomaterials and how to limit those risks," PEN director David Rejeski told Medical Device Daily.

Rejeski's comments were a reaction to strategy reports just released by the Nanotechnology Environmental and Health Implications (NEHI) Working Group of the National Nanotechnology Initiative (NNI, Washington) and the Environmental Protection Agency's (Washington) Office of Research & Development.

The NNI report focuses on strategy for nanotechnology environmental, health and safety research, while the EPA plan includes studies on risk assessment methods and life-cycle analysis to determine the eventual fate of nanomaterials.

"As these products that incorporate nanotechnology move into the market, there needs to be a lot more money invested in agencies such as the FDA and EPA — they are radically underfunded," Rejeski said.

"One of the most stunning findings is that the FDA is losing scientists — it's bleeding expertise. They are not really even keeping up with advances in genomics, so how are they going to keep up with nanotechnology? There's an enormous amount of expertise needed to judge these products."

The NNI strategy outlines an improved focus on risk research for more than 20 federal agencies, including the EPA, FDA and the Consumer Product Safety Commission (CPSC; Washington). The strategy identifies priority research needs and assigns lead agencies to address these needs.

"We have to go back through all the research [identified in the strategy reports] and find out whether these projects are slightly or highly relevant. We've called some of these researchers, and we've found that nanotechnology is maybe a small part of their work," Rejeski said, pointing out that only five of the more than 240 identified risk research projects on the NEHI strategy report actually focus on exposure assessment, which directly affects workers.

"These are the people who are on the front line and most likely to be exposed to potentially hazardous nanomaterials," he said.

PEN lists 600 nanotechnology-related products in its database, of which half are potentially under the oversight of CPSC. CPSC does not receive funding from NNI.

"They have to make hard calls about whether product are safe or not," Rejeski said.

In short, he argues that the NNI and EPA recommendations are not guided by a top-down strategy tied to projected product commercialization, expected human and environmental exposures, and the regulatory decision-making process.

"The agencies need to be realigned," he said. "Federal strategy is all driven by stuff the researchers want to do. But what's the research linked to?

"The reports fail to employ a top-down, strategic approach aimed at directing funds and research at the places where there's likely to be the most risk."

Rejeski said the proposed strategies would be much more useful if they had included lists of nanotechnology-related products on the market and those soon to be on the market.

"With that sort of information, you can begin to identify the types of workers likely to be exposed the nanotech materials and act on that," he said.

PEN asserts that the NNI plan is a collection of individual agency research programs and not a strategic approach appropriate to a technology projected to be incorporated into $2.6 trillion worth of products by 2014. An earlier analysis by PEN showed that in 2005, the U.S. government spent about 1% of the overall $1.2 billion federal nanotechnology research investment on relevant risk research.

The current strategy suggests that things have improved, but according to Rejeski, "Transparency over what is being done and what needs to be done is essential to strategic planning. The cited $68 million invested in nanotechnology risk research in fiscal year 2006 is an inflated estimate of work that directly addresses the issues, and that can only further confound the formulation of an effective strategic plan."

PEN also is worried that the public is woefully uninformed about nanotechnology and can't possibly influence the government's actions without more knowledge.

"The government has totally failed in terms of public engagement," he said. "Our polling shows 70% to 80% of Americans know very little about nanotechnology. It's tough for companies do go out and do this kind of work. The government was told to do this [via the 21st Century Nanotechnology Research and Development Act, which authorized funding for nanotechnology research and development over four years, starting in FY 2005] and they failed."

Rejeski estimates that these issues might change when Congress is faced with reauthorizing the act later this year. "I would assume that when they reauthorize the act, they may try to change what goes on and make sure the research money goes to the most appropriate places such as the FDA.

"We're big supporters of the FDA," he said. "The last thing you want to do when introducing a new technology is to have the FDA not be in a position to analyze and regulate it properly because they don't have the appropriate resources."