We’ve said that nanotech is the next big thing in biotech. Now, the U.S. Food and Drug Administration has formed an internal task force to focus on the use of nanotechnology materials in drugs, medical instruments, and other products regulated by the agency. The new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.
The task force will identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials. FDA will continue to address product-specific nanotechnology-related issues on an ongoing basis.
Specifically, the task force will:
Chair a public meeting to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products, including new and emerging scientific issues such as those pertaining to biological interactions that may lead to either beneficial or adverse health effects. This public meeting is scheduled for October 10.
Assess the current state of scientific knowledge pertaining to nanotechnology materials for purposes of carrying out FDA’s mission.
Evaluate the effectiveness of the agency’s regulatory approaches and authorities to meet any unique challenge that may be presented by the use of nanotechnology materials in FDA-regulated products.
Explore opportunities to foster innovation using nanotechnology materials to develop safe and effective drugs, biologics and devices, and to develop safe foods, feeds, and cosmetics.
Continue to strengthen FDA’s collaborative relationships with other federal agencies, including the agencies participating in the National Nanotechnology Initiative such as the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), as well as with foreign government regulatory bodies, international organizations, healthcare professionals, industry, consumers, and other stakeholders to gather information regarding nanotechnology materials used or that could be used in FDA-regulated products.
Consider appropriate vehicles for communicating with the public about the use of nanotechnology materials in FDA-regulated products.
Submit its initial findings and recommendations to the Acting Commissioner within nine months of the public meeting.
The National Nanotechnology Initiative (a United States government research and development coordinating program,) refers to nanotechnology as “the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications.” A nanometer is a billionth of a meter.
Materials made in the nanoscale size range can often have chemical or physical properties that are different from those of their larger counterparts. Such differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity. Because of these properties, nanotechnology materials have great potential for use in a vast array of products. Also because of some of their special properties, they may pose different safety issues than their larger counterparts.
This comes as the Motley Fools warn everyone to “Beware the Nano Lawyers!” (sounds like a great Hollywood thriller) .
Demand for nanotech health-care products is projected to hit $6.5 billion in 2009, up from $906 million in 2004, according to a 2005 report from the Freedonia Group. The total market may exceed $100 billion by 2020. Sales of pharmaceuticals created or modified with nanoparticles will grow to $16.6 billion by 2014.
