Diagnostics & Imaging Week

Most technologies, and especially medical device technologies, become more useful as they become smaller. And so it comes as no surprise that the science of extremely small things – nanotechnology – is finding its way into medical device products.

But FDA actions taken to address the issues surrounding nanotechnology have been few and far between, according to the Food and Drug Law Institute (Washington), leaving some experts questioning the agency’s nano-readiness.

According to a recent Insighter article, written by Beryl Lieff Benderly, posted on the Food and Drug Law Institute’s web site, FDA is just beginning to address the issues presented by nanotechnology, even though hundreds of nanotech products have already reached the market.

In the area of medical devices the critical issue for nanotechnologies is the lack of risk-research for nano-scale materials, said Julia Moore, deputy director of the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars (WWC; Washington).

Though Moore told Diagnostics & Imaging Week that the organization doesn’t anticipate a lot of problems with nanotechnology – or “nano-dangers” – she said that more research is needed in this area so FDA can regulate these products.

“The agency needs that added expertise and those resources to be able to continue to ensure the safety of the product,” Moore said. She acknowledged that FDA is in the process of gathering information but “has not one dime for risk-research on nano-material.”

“So yes, they are doing things, but they clearly don’t have the resources to do what is needed and necessary.”

A special FDA nanotechnology task force concluded in its July 2007 report that the agency has the capability to meet the challenges associated with the technology, but it needs to take specific action soon to get ready. However, according to the Insighter article, FDA has not made public its plans for responding to the task force report.

The article quotes FDA spokesperson Crystal Rice as saying: “We are beginning the planning for the priority activities defined in the task force report.” (Importantly, not planning, but “beginning the planning.”)

This certainly isn’t the first time the agency’s nano-preparedness has been questioned.

A report by former FDA deputy commissioner for policy Michael Taylor, “Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?” published in 2006 by the WWC nanotechnology project, indicates that the agency is not, in fact, nano-ready.

“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,” Taylor said when the report was published.

Moore said an analysis on the Project on Emerging Technologies was conducted using 2006 data found that more than 130 nano-based drugs and delivery systems and about 125 devices or diagnostic tests were in development. But, she said, “We believe that’s an old number.”

Moore said that the FDLI sees nanotechnology as “a good thing — we think nanotechnology is going to revolutionize medicine — and that sounds like hyperbole, and I think it’s not.”

Among the device companies developing products using nanomaterials are:

• Nanosphere (Northbrook, Illinois), which raised $100 million last year in its initial public offering. The company received FDA clearance for its Verigene system, a random access, molecular diagnostics workstation for nucleic acid and protein diagnostics, in September. The system uses gold nanoparticle technology to detect nucleic acid targets in a multiplex format.

• Nanomix (Emeryville, California), a nanoelectronic detection company selling high-value diagnostic and monitoring applications. Its Sensation platform is designed to enable detection of a broad array of chemical and biomolecules. It has high specificity and reproducibility, operates at room temperature, consumes little power, and permits both wireless integration and simple deployment, according to the company.

• Alpha Szenszor (Woburn, Massachusetts), a company developing sensor products in the medical field, last year reported licensing biomedical sensors from Nanotero (also Woburn), a nanotechnology company using carbon nanotubes for the development of next-generation semiconductor devices.

Moore offered three reasons why the medical device industry is seeing attention in the field of nanotechnologies.

On a worldwide basis, there is about $12 billion in R&D invested in nanotechnology, she said, and the U.S. government alone last year invested $1.4 billion. “So there’s been over the last decade a ramped-up worldwide investment in this area. So if you have this investment you are going to very clearly see products from that R&D.”

She called nanotechnology “an enabler of many wonderful things in the medical field. Just in the device area, for example, you’re going to be able, and you are able to use, nano-silver as an antimicrobial. Nanotechnology . . . does do wonderful things.”

She said that when the investment community is polled concerning where they would most like to see nanotechnologies applied, it’s in the medical sector.

“People are much more interested in seeing treatments for cancer and Alzheimer’s than having a lighter tennis racket or golf club,” she said (noting that sporting goods is another area where nano silver can be used). Plus, “it’s high value. You get a lot more money from a medical diagnostic investment than you do in sporting goods and sports clothing.”

The FDLI and the WWC Project on Emerging Nanotechnologies, in partnership with Burdock Group and Arizona State University (Tempe), are sponsoring a conference on nanotechnology law, regulation and policy in Washington Feb. 28-29.

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