Medical Device Daily Washington Editor

The FDA’s conference on nanotechnology this past Tuesday brought many issues and concerns to light, but while the agency is putting much more focus on this area of modern technology, it acknowledges that it is far from being sufficiently schooled to offer any comments on how it might regulate nanomaterials in the years to come.

The conference also made clear that despite a volume on nanotechnology by the “For Dummies” publishers, underlying issues will keep both the agency and industry busy for years to come sorting out the scientific/regulatory issues and dealing with the public’s reaction to this branch of science.

Celia Merzbacher, PhD, who serves as a liaison between the U.S. Office of Science and Technology Policy and several other federal agencies, gave an overview of the National Nanotechnology Initiative (NNI). She said that the FDA nanotechnology task force had several charges to deal with, including assessing the FDA’s readiness to provide adequate regulatory oversight of nanotech products.

And Merzbacher’s presentation included one slide that gave many members of the audience a lot to worry about.

The 2005 and 2006 budgets for the NNI included no funding – as in zero — for the FDA’s work in this area, and the agency’s budget request for 2007 is similarly zero, despite an overall agency funding of more than $1.25 billion.

Norris Alderson, the associate commissioner for science at the FDA, who emceed the gathering, emphasized this fact for the audience following her presentation.

A number of other presenters also made a point of arguing that however one feels about nanoparticles, this lack of funding renders the FDA unequipped to deal with them.

John Balbus, MD, a senior scientist at the Washington office of Environmental Defense (ED; New York), decried the agency’s “limited authority and limited resources” to cope with the task.

The question of how quickly the public will welcome nanoparticles and other exotic matter into their lives also arose.

Balbus insisted that while ED generally supports nanotech development, the agency’s “public communications really do not inspire confidence” in its approach to this new frontier.

He added that FDA’s position — that particle size is not the crux of the matter where toxicity is concerned — does not jibe with much published literature on the subject.

Balbus said that the ability of nanoparticles to penetrate the skin suggests the potential for systemic effects and argued for pre-market evaluation of topicals and cosmetics as well as the need for great caution in reviewing drug delivery via nanoparticles.

Martin Philbert, MD, professor of environmental health sciences at the University of Michigan (Ann Arbor) sounded a more reserved note on the topic than some of the other speakers at the morning session.

“The take-home message is that there’s no need to panic” about nano-matter based on current experience, Philbert said. He argued that, to date, the benefits “far outweigh the risks” and that at present “there’s no need for draconian action.”

Philbert made the case that where drugs and other chemical substances are concerned, “it is not the nanoscale, necessarily, that imparts toxicity,” and that studies of various drugs suggest that the toxicity of some are not influenced by how they are delivered.

David Rejeski, director of the Foresight and Governance Project at the Woodrow Wilson Center (Washington), echoed the calls for the importance of FDA funding to keep track of nanotechnology.

“As many are beginning to realize, FDA simply does not have the resources it needs to do what people expect” to ensure the safety of such products.

He estimated more than 300 “nanoproducts” currently on the U.S. market, coming in from 17 countries, and that each year the public and private sectors plow more than $10 billion into various nano-initiatives. He urged a proactive approach by industry and government to head off potential problems.

Addressing public concerns about nanomatter, Rejeski said that according to at least one survey, “once people learn about nanotechnology . . . there’s very little support for a moratorium” on its development. But he insisted that “trust is extremely fragile” and that there is no benefit to be had from a “stealth revolution” in medical science.

“FDA should do more to earn the public’s trust” on this issue, he said.

Compared to drugs, topicals and cosmetics, there was relatively little discussion of the impact of nanotechnology on the device industry, but that seems likely to change soon. Speaking for the Advanced Medical Technology Association (AdvaMed; Washington), Bernie Liebler, the association’s director of technology and regulatory affairs, said that he anticipates that nanoparticles “will be integral to a wide range of devices” in the years to come.

Liebler said he expects that nanoparticles will show up not only as principal device components, but also as subsidiary components or elements of processing that “alters or otherwise improves the performance of the component by improving tensile strength or electrical conduction.”

He pointed out, however, that “it’s difficult at this point to predict with any accuracy where the bulk of the nanotechnology-enabled development will occur” because this sector “moves much too quickly to make accurate predictions.”

Diagnostics will become smaller due to nanotechnology, and the friction coefficient for the sockets in replacement hips will probably improve drastically thanks to nano-materials.

“AdvaMed believes,” he said, “that it is in the best interest of industry and the patients it serves to work as closely and openly as possible with FDA in exploring nanotechnology, it’s scientific and engineering characteristics and regulatory aspects.”

And he urged a concerted effort by industry and government “to educate the public about the relative benefits and risks of nanotechnology-based products.”