Analysis: No big changes for nanotech regs

By STEVE MITCHELL, UPI Senior Medical Correspondent  |  April 14, 2006 at 6:14 PM
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WASHINGTON, April 14 (UPI) -- The Food and Drug Administration plans to take a closer look at nanotech later this year, but experts said they don't expect the agency to make any significant regulatory changes that would affect the pharmaceutical and biotech industries.

The FDA said the meeting, scheduled for next fall, is "designed to gather information about current developments in uses of nanotechnology materials in FDA regulated products," including pharmaceuticals, biologics and medical devices.

Nanotech as it applies to medical treatments typically entails the use of nanometer-sized particles -- which are thousands of times thinner than a human hair -- to detect and treat diseases at the molecular level.

The FDA said it will be focusing on several areas, including new types of nanotech products under development and scientific issues relevant to FDA's regulation of these products. The agency said it also wants to be informed of hurdles that may be inhibiting the use of nanotech in medical product development that it can address.

Clayton Teague, director of the National Nanotech Coordination Office for the National Nanotech Initiative, told United Press International he didn't expect any new regulations to be issued by any of the federal regulatory agencies that oversee products incorporating nanotechnology.

"The regulatory agencies report to us that they don't foresee completely new statues being necessary," Teague said. "They see in the current regulatory framework a sufficient degree of options they could exercise ... if they needed to, to appropriately regulate nanobased products and materials," he said.

Christine Peterson, vice president of public policy for the Foresight Nanotech Institute, a non-profit think tank based in Palo Alto, Calif., echoed those sentiments.

"My guess is this meeting is going to focus on food and cosmetics and not so much on medical," Peterson told UPI. "I would be surprised if it had a big impact" on the pharmaceutical and biotech side of the nanotech field, she added.

Matthew Laudon, executive director of the Nano Science and Technology Institute, told UPI there are indications that pharmaceutical and biotech companies are becoming increasingly interested in incorporating nanotech into their products.

"Just in the last 2 years, we've really seen an awakening from some of the bigger pharmaceutical companies," Laudon said. He noted that two pharma giants, Pfizer and Novartis, are participating in his organization's Nanotech Conference and trade show, which takes place next month in Boston.

The reason for pharma's increased interest, he said, is that applications are starting to come out that incorporate nanotech and the National Institutes of Health has put out "a number of very large initiatives" focused on the technology. For example, the NIH's National Cancer Institute has made a big commitment to nanotech and sponsors a multi-day symposium at the Nanotech conference on applying the technology to cancer diagnostics.

"The NIH funding has brought about a big participation from the research side of things and corporations are starting to see value," Laudon said.

One indication of the increased interest from industry is a big jump in patents and portfolios of early stage companies that were submitted as part of the annual meeting. In previous year, the life sciences accounted for about a third of all such submissions, but this year "it probably take up about half," he said.

"I think the next few years will be very large, especially with the NIH funding," he said. "The NIH projects are just starting up now and so you are going to see a lot of new tech coming out in next 3 to 5 years related to those."

One issue that has dogged the technology is safety, and the National Nanotechnology Initiative has placed a strong emphasis on investigating whether the new nanotech products pose toxicity concerns for humans or the environment, Teague said.

"We think anytime there is any data to indicate there is any risk, it should be taken very seriously," he said. "It is investigated immediately to try to make sure it's understood and to ensure public safety and public health," he added.

Although Teague said he would never dismiss safety concerns out of hand, he said it was important to note that nanoscale particles are not new to the world.

"We've had nanoscale particles in the environment in many, many different ways since the dawn of men," he said. But it's only now that "we are learning a lot more about the implications they have for human health and the environment, and ultimately we think that understanding will enable us to engineer nanobased products that will be benign for the environment and for humans."

Safety concerns about nanotech were recently rekindled by reports out of Germany of dozens of people who developed severe respiratory problems after using a bathroom cleaning product called "Magic Nano" that claims to incorporate nanoscale particles (although some have questioned whether this is merely a marketing ploy to capitalize on the hype about nanotech products).

The manufacturer, Kleinmann GmbH, recalled "Magic Nano," in what appears to be the first health-related recall of a nanotech product. According to the Project on Emerging Nanotechnologies, there are more than 200 consumer products on the market that claim to be made with nanoscale particles or using nanotechnology.

The FDA did not respond to UPI's request for comment on this story.

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