FDA's Nanotechnology Public Workshop, conducted in October, produced much debate about the risks and benefits of nanotechnology and the changes FDA needs to make in order to properly regulate it. It became clear that we don't yet fully know the extent of the safety risks of nanomaterials. But it also became clear that these materials should not cause radical changes to FDA's regulatory framework, at least as far as their use with medical devices is concerned.
Early in the day, some representatives of consumer groups engaged in hysteria, calling for a ban on all products with nanomaterials, even recalling the ones already on the market until more research about risk is done. Then, they said, when nanotech products are allowed on the market, they should be heavily regulated by FDA. Some suggested that the agency set up a separate center just to review nanotech products. They showed results of studies that found that materials at their nanoscale have different properties than they do at their bulk scale, and that some become more toxic, both to the human body and to the environment.
But there were other studies presented that showed that in many cases, the nanoscale materials become less toxic than their bulk counterparts, or show no difference. And one study proved that it is not the size, per se, that indicates toxicity, but rather the characteristics of the individual material. Martin A. Philbert, PhD, professor of toxicology at the University of Michigan School of Public Health (Ann Arbor), said that it is foolish to generalize about the safety of nanomaterials when evidence so far shows that some are safe and some are not. “Until there are enough data to draw broad conclusions, [a case-by-case approach] is what you have to [take],” he said.
FDA's regulatory structure is already set up for a case-by-case approach, which presents the agency with a great opportunity as it begins to regulate nanotech products. The key is to make sure that the agency has the expertise to properly evaluate the toxicity of the relevant nanomaterials, and the safety and effectiveness of the products resulting from them.
As the day went on, it became clear that the naysayers' concerns are not particularly valid as far as device applications go. The reason is that there is already a premarket review process. Furthermore, firms that submit applications for complex devices are already consulting with FDA presubmission about what sort of testing should be done. Most of the posturing, however, concerned the use of nanotechnology in products such as cosmetics, for which there is no premarket review process.
Bernie Liebler, AdvaMed's director of technology and regulatory affairs, drove this point home in his presentation. He made a strong case about why there does not need to be a separate regulatory track for nanotechnology device products.
In fact, he said, as far as devices are concerned, there's no reason why nanotechnology issues can't be integrated into the current framework.
“The current [premarket] process, particularly the PMA, requires consultation about what tests should be used and what clinicals will be run,” he said. “There's a lot to talk about in advance. That is the perfect opportunity to address any nanotechnology aspects. It's already there.”
And, Liebler said the device industry would “work as closely and openly as possible with FDA” to make sure the agency has as much data as it needs to make the right decisions.
What the nanotech revolution means for device regulation is that device companies will have to get more familiar with toxicology testing, and FDA will have to hire some nanotechnology experts for the Office of Device Evaluation. As long as those two things happen, FDA and industry should be able to address safety issues appropriately.
Erik Swain for the Editors