By Ricardo Carvajal –
The National Nanotechnology Initiative ("NNI") released its draft 2014 Strategic Plan for comment. The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011 (see here). As with the 2011 Plan, the draft 2014 Plan includes a description of FDA’s NNI-related activities. Those activities continue to be primarily focused on the goal of supporting responsible development of nanotechnology. However, the 2014 Plan more explicitly recognizes the potential impact of nanotechnology on the status of FDA-regulated products:
The use of nanotechnology can alter the safety, effectiveness, performance, and/or quality of FDA-regulated products. For this reason, FDA is interested in additional scientific information and tools to help better detect and predict potential effects of such changes on human or animal health.
This statement is consistent with FDA’s issuance last year of nanotech-related draft guidance documents that address the safety of nanomaterials in cosmetic products, as well as the potential impact of manufacturing changes (including emerging technologies) on the safety and regulatory status of food ingredients and food contact substances (see our previous post here). Those documents put industry on notice that FDA expects manufacturers to assess any potential impact of the use of nanotechnology on the regulatory status of their products prior to marketing.
As the 2014 Plan was being released for comment, the New York Academy of Sciences hosted a conference on potential scientific and regulatory gaps that could be holding back the growth and development of nanomedicine (defined as “the application of nanotechnology for the treatment, diagnosis, monitoring, and control of biological systems”). Among other things, the conference touched on the following issues:
- Characterization - The National Characterization Laboratory ("NCL") of the National Cancer Institute addressed the challenges associated with characterization of nanomaterials (NCL provides free characterization and safety testing of nanoparticles intended for use as cancer therapies or diagnostics – see here).
- “Nanosimilars” – Several presenters discussed follow-on therapeutics, referred to in this context as nanosimilars, with particular attention to the differences that slight changes in manufacturing could have on a product’s safety and efficacy (see, e.g., here).
- Regulatory and patent issues – Summaries were provided of the FDA’s and the European Medicines Agency’s approaches to regulation of products derived through nanotechnology, as well as obstacles posed by the proliferation of nanotech-related patents (see, e.g., here).
- Classification and nomenclature – The definition of nanotechnology in the context of pharma R&D continues to be an issue of concern to some observers (see here).
Notwithstanding these and other challenges, case studies of several marketed products made clear that success is possible, and suggest that the potential benefits of nanotechnology in the medical products sector have only just begun to be tapped.