The science of very, very small things that can be used in healthcare products has a big problem.

Such is the conclusion of a new report on nanotechnology for health, released last week, just shortly before a major FDA meeting on the subject.

A "public workshop" being held by the agency Tuesday on the campus of the National Institutes of Health is essentially the agency's major public foray into the subject. Its goal: to determine the limitations and potential advantages of this technology and what the agency needs to do to prepare for regulating the nano-products poised to come its way.

But the new report — "Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?"— very strongly indicates that the agency's "nano-readiness" … well, largely isn't.

Written by Michael Taylor, a former deputy commissioner for policy at the FDA, the report indicates that the agency's glass of resources for understanding and regulating nanotechnology-based products is much less than half-full. But Taylor told Diagnostics & Imaging Week that its "spirit … is to be helpful, not point the finger of blame. Society needs to give the FDA the tools to regulate it."

Commissioned by the Project on Emerging Nanotechnologies of the Woodrow Wilson Center (Washington), the report finds FDA's resource base severely eroded and therefore hardly in a strong position to take on the added task of dealing with nanotech-based products, especially given a variety of unknowns and their intrinsic technical complexities.

For the medical device sector, he says that "the issue is obviously not legal tools. The agency's medical devices toolkit is quite full.

"The issue is, does the agency have the scientific tools to understand and evaluate this technology to make good decisions? Can it make these decisions in a timely way so as not to slow innovation?"

The prospect of tardy innovation, of course, is hardly music to the ears of the medical device industry.

And Taylor's broader assessment of the situation here is even more pessimistic: "There is a question about whether the scientific community in general has the tools to evaluate this technology."

In a press statement summarizing the report's conclusions, Taylor throws in other factors suggesting a slowed, rather than speedy, regulatory process for nano-health products: "the increasing cost of doing business, coupled with the failure of Congress and successive administrations to adequately fund even FDA's base operations." These he says, "are a real threat to FDA's ability to effectively oversee nanotechnology."

"That's a chronic problem for the FDA," Taylor told MDD. Then comes nanotechnology as "the latest challenge to FDA and its resources, and it has no spare resources to shift around."

He estimates that the FDA currently has about $1 million "across the agency," with those dollars focused on a rather niche development — the "dermal absorption of cosmetics."

Meanwhile, he says, "the thought processes and conversation currently go on, but they're in the early stages of the nanotech era."

He says, however, that the agency's lack of "nano-readiness is about more than dollars."

While he believes the agency has sufficient legal tools on the medical device side, he says they are lacking in other areas, primarily cosmetics and dietary supplements and in the oversight of products after they reach the marketplace."

That, of course, has been a recurring criticism, in terms of the agency's post-market surveillance capabilities.

"There are over 300 manufacturer-identified nanotechnology consumer products being sold to Americans," Taylor notes. "FDA should take some immediate steps to gather information about this first wave of nanotechnology products and to set the criteria for determining when a nanoscale material is 'new' for legal, regulatory and safety purposes. By acting promptly, FDA will be in a better position to prevent regulatory and safety problems rather than having to react later, after the fact."

David Rejeski, director of the Project on Emerging Nanotechnologies, underlines Taylor's concerns by noting the potential broader fallout that could result if nanotechnology products ultimately are found to be harmful.

Nanotechnology, he said, has "enormous potential to benefit consumers and patients will be realized, [but] only if its safety is understood and reasonably assured. Consumers rely on the FDA to judge what is safe and unsafe. Unless the FDA addresses potential nanotechnology risks now, public confidence in a host of valuable nanotechnology-based products could be undermined."

In his report, Taylor reviews Congress and FDA's history of responding to new technologies and the public's well-fixed expectation that FDA should be able to both ensure the safety of novel products before they enter the market and detect and swiftly correct post-market problems.

Taylor more than once emphasizes that the report's intent is not to criticize an already over-pressed agency but to encourage Congress and the public to back its efforts in the area by stimulating discussion. "Business and health leaders alike should join in ensuring that FDA has the scientific tools and knowledge it needs to say 'yes' to safe and effective new products."

The report puts the market opportunity for nanotechnology at more than $30 billion in manufactured goods in 2005 — more than double the previous year. And it notes a study by Lux Research (New York) that puts the opportunity, by 2014, at $2.6 trillion in global manufactured goods, about 15% of total output.

Estimates put the U.S. annual investment in nanotechnology R&D, at about $3 billion, accounting for about one-third of the total public and private sector investments worldwide.

Taylor is a professor at the University of Maryland School of Medicine (Baltimore), where he conducts research on policy, resource and institutional issues that affect public health agencies in carrying out their prevention missions. He was administrator of the USDA's Food Safety and Inspection Service from 1994 to 1996; deputy commissioner for policy at the FDA from 1991 to 1994; and an FDA staff lawyer and executive assistant to the FDA Commissioner from 1976 to 1981.

The Project on Emerging Nanotechnologies is an initiative launched by the Wilson Center and The Pew Charitable Trusts in 2005. It is focused on helping business, government and the public anticipate and manage possible health and environmental implications of nanotechnology.

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