The FDA’s nanotechnology task force — launched about a year ago — last week released a report recommending what many have said should have been done months, if not years, ago: that the agency develop guidance and take other steps to address the benefits and risks of devices and drugs using nanotechnology.
During a conference call to discuss the report, Randall Lutter, PhD, FDA deputy commissioner for policy, opened by quoting FDA Commissioner Andrew von Eschenbach, MD, as saying that the report “sets the stage for a comprehensive approach to the regulation of products subject to FDA jurisdiction including a focus on product safety.”
And perhaps inadvertently, Lutter made a statement tacitly acknowledging that FDA is behind the nanotech curve and needs to catch up: “Nanotechnology,” he said, “is already changing the way that medical materials and medical devices are made,”
“The field may provide new roots to deliver drug treatments to areas of the body that previously were inaccessible. Nanomedicine includes development of tiny sensors that detect disease markers in the body far earlier than existing diagnostic methods and incredibly small pumps capable of delivering medications precisely where they are needed.”
There is increasing interest in nano-sized materials — those created at sizes as small as 1/100,000th the width of a human hair — as one of the newest waves in a whole range of product areas, and Lutter said, “broadly speaking, in medical devices people are really excited” about nanotechnology.
Other examples of nano-products in development cited by Lutter included disease imaging tools and food packaging that extends shelf life.
“FDA will be closely following the developments in the fast-moving field of nanotechnology in order to prepare for a review of products that may be developed in the future,” he said.
Scientists and researchers increasingly are working in the nanoscale, the agency noted.
“Nanotechnology holds enormous potential for use in a vast array of products,” Eschenbach said in an agency statement endorsing the task force report and its recommendations. “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.”
Among the regulatory and scientific issues and recommendations of the task force report, it advises that FDA consider development of nanotechnology-associated guidance for manufacturers and researchers. And Lutter said the FDA will, over the next few months, begin drafting guidances related to nanotechnology.
Specific report recommendations include the call for manufactures to contact the FDA early in the product development process, Lutter said — no particular surprise there since that is what the agency advises all companies that it deals with.
In addition, it says that the agency should work to facilitate the assessment of data needs for regulated nanotechnology products including biological effects and interactions of nanoparticles with biological systems.
And the report recommends that the FDA should develop in-house expertise and ensure the consideration of new information on nanotechnology as it becomes available — another non-surprise since the agency has been saying that one of its overall key goals should be to ramp up its expertise concerning all new technologies impacting med-tech.
“FDA also should evaluate current testing approaches to assess the safety effectiveness and quality of nanoscale materials,” Lutter said.
Last October the task force hosted a public meeting in Washington on nanotechnology to help the FDA further its understanding of developments in nanotechnology materials, including issues pertaining to biological interactions that may lead to either beneficial or adverse health effects.
The task force, Lutter said, found that nanoscale materials potentially could be used in most product types regulated by the FDA and that those materials present challenges similar to those posed by products using other emerging technologies.
Those challenges, however, may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale, he said.
The report also emphasizes the need for ensuring transparent, consistent, and predictable regulatory pathways because of the particularly uncertain nature of nanotechnology and the rapid development of specific application employing nanotech.
It recommends, for example, consideration of agency guidance that would clarify what information about nanotech-related products should be provided to the agency, 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, the agency said.
Asked during the call’s Q&A if the agency is considering special labels for nano-products, Lutter said that the task force does not believe it has scientific evidence about nano-sized materials posing safety questions that would merit being mentioned on the label.
The FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal R&D program to coordinate multi-agency efforts in nanoscale science, engineering, and technology, the agency noted.