Sizing up the regulators

3 August 2007

With nanotechnologies used in a widening array of products, regulators are considering closer scrutiny of their use in drugs and medical devices. What will that mean for researchers and manufacturers?

What are the chances that scientists, entrepreneurs, angel investors, VCs, multinationals and politicians can unite across industry sectors and geographies to protect the world from the potential dangers of nanotechnology?

Probably zero. Which may help explain why the US Food and Drug Administration (FDA) is looking to get up to speed with the science that lies behind a wave of new developments in the drug and medical devices field. The agency's own Nanotechnology Task Force issued a report last week urging it to develop guidance for manufacturers and researchers and improve its knowledge and expertise.

The report comes amid ongoing concerns about the safety of nanotechnologies. The tiny materials - manipulated at the level of atoms and molecules, and measured at 1/100,000th of the width of a human hair - offer the tantalizing prospect of huge advances in medical care and other fields, both civilian and military. But they also carry risks that as yet aren't fully understood. We already know, for example, that nanoparticles can be absorbed by liver cells, which could have positive implications for treatments - but does that mean they can be absorbed by bacteria too, and as a result enter the food chain? Likewise, are nanomaterials non-degradable - and if so, what are the environmental implications?

Although some of the scare stories about nanotechnology are extreme - including the fear of terrorists using them to wreak havoc in unimaginable new ways - the problems are immediate. While nanotechnology is popularly perceived to be the plaything of scientists in research labs, the reality is that nanoscale products are already freely available to consumers. According to the ETC Group, a pressure group based in Canada, hundreds of consumer products already contain nanomaterials, ranging from cosmetics and clothing to baby products and food.

As the FDA Task Force reports, nanoscale materials present similar challenges to other emerging technologies for regulators, but with additional complications. For one thing, nanotechnology can be used in any FDA-regulated product - and worse, the nanotech properties that affect product safety and effectiveness may actually change as their size varies. In addition, of course, the FDA doesn't regulate everything. The Task Force concluded that the agency has comprehensive authority for products subject to pre-market authorisation, like drugs, devices and biological products. But in other areas, such as cosmetics and food ingredients that are generally recognised as safe, manufacturers don't usually have to submit data to the FDA prior to marketing them.

To tackle these issues, the Task Force recommends that the FDA issues guidance to clarify exactly what information manufacturers should give it. It also urges the agency to assess its own data needs - including the biological effects and interactions of nanomaterials, improve its in-house expertise and re-evaluate its current testing approaches.

So given the global implications of FDA policy-making, does this mean that scientists and entrepreneurs working with nanotechnologies are about to come under vastly closer scrutiny? Not immediately. While it's likely that a regulatory framework will eventually be developed, it's certainly not going to happen overnight. 'Such a framework will likely be needed in the future,' says Dr. Patrick Lin, research director for the independent Nanoethics Group, 'but it seems to be too early to implement one now without being overly broad. We're still waiting for (more) evidence of toxicity in or environmental harm from nanomaterials. And to complicate things, each nanomaterial is different and needs to be considered or tested separately. So it's premature and over-reaching to label all nanomaterials as somehow hazardous and in need of regulation.'

The alternative is self-regulation, and as awareness of the potential dangers of nanotechnologies grows, it's possible that public pressure will force manufacturers to develop their own guidelines in specific areas to provide reassurance about safety. But again, there are practical challenges - not least the fact that there's no single industry to police itself. 'It's an amalgamation of diverse industries, each one difficult enough to regulate by itself,' says Lin. 'There would have to be some cross-industry coalition which has perhaps never been seen before. And because different industries may use different nanomaterials, the likelihood of any consensus or cooperation is slim, given different interests and degrees of risk.'

He concludes: 'For the same reason anarchy doesn't work as a serious political model, there needs to be some fairly disinterested oversight and credible sanctions to help companies, which are largely motivated by profits, do the right thing. Which reminds me of Churchill's quote: 'In the end, Americans will always do the right thing... after exploring all other alternatives.''

By Keith Rodgers, Webster Buchanan Research