The US Food and Drug Administration (FDA) should consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology, according to a report released by the FDA Nanotechnology Task Force on July 25.
Nanoscale materials could potentially be used in most product types regulated by the FDA, and those materials present challenges similar to those posed by products using other emerging technologies, according to the report.
"The challenges, however, may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale," the FDA said in a statement.
The task force also said the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products highlight the need for ensuring transparent, consistent and predictable regulatory pathways.
Anticipating the potential for rapid development in the field, it recommends consideration of agency guidance that would clarify, for example, what information to give FDA about products, and when the use of nanoscale materials may change the regulatory status of particular products. As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.
In addition, the task force said the FDA should work to assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials. The agency should also develop in-house expertise and ensure consideration of relevant new information on nanotechnology as it becomes available, according to the report, and it should evaluate the adequacy of current testing approaches to assess safety, effectiveness and quality of nanoscale materials.
"Nanotechnology holds enormous potential for use in a vast array of products," said Commissioner of Food and Drugs Andrew von Eschenbach, MD, who endorsed the task force report and its recommendations on July 23. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials."
Scientists and researchers increasingly are working in the nanoscale, creating and using materials and devices at the level of molecules and atoms—1/100,000th the width of a human hair.
The FDA Nanotechnology Task Force Report on Nanotechnology addresses regulatory and scientific issues and recommends FDA consider development of nanotechnology-associated guidance for manufacturers and researchers. The task force was initiated by von Eschenbach in 2006.
The FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering and technology.
For the most part, FDA experts believe that nanotechnology products present challenges similar to those FDA faces for products of other emerging technologies, the agency said. "FDA experts recognize, however, that product safety and effectiveness can change as size goes up or down within the nanoscale, adding additional complexity to the product review. It’s also possible that nanotechnology will be used in a wide variety of products, such as foods, drugs, cosmetics and medical devices.
"Nanotechnology is currently used in such fields as display technology for laptop computers, cell phones and digital cameras, and in water filtration," the FDA said. "And nanomedicine is an area of biomedical research that seeks to use nanoscale tools to improve health.
"Current medical uses of nanotechnology include burn and wound dressings, a dental-bonding agent, sunscreens, protective and glare-reducing coatings for eyeglasses. Some day, you may see nanotechnology used in food packaging to further extend shelf life or used medically to provide new drugs that are able to reach sites in the body more effectively and at safer doses, to create tiny sensors that detect diseases in the body far earlier than existing diagnostic tools, or to manufacture incredibly small pumps that can be implanted to deliver lifesaving medications precisely to the cells and tissues that need them," the agency said.
The FDA said it expects that many of the nanotechnology products it will regulate will span the regulatory boundaries between drugs, medical devices and biologics. These would be regulated under the rules established for "combination products," it said.
The task force report is available at: www.fda.gov/nanotechnology/taskforce/report2007.html
