Biotechnology

On June 9, 2011, the U.S. Food and Drug Administration announced a draft Guidance for Industry about the use of nanotechnology by industries the agency regulates, calling it the “first step” in determining whether products contain the emerging technology.

The draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA's approach to nanotechnology.

FDA is releasing its document in coordination with the "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials" issued on June 9, 2011, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.

The guidance is intended for manufacturers, suppliers, importers and other stakeholders. The guidance describes FDA’s current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.

A new study was published on-line November 5, 2009, in Nature Nanotechnology with a provocative title: Nanoparticles can cause DNA damage across a cellular barrier.

The study was led by a team from the Bristol Implant Research Centre, UK, and raises some concern over the safe medical use of nanoparticles. The nanoparticles studied were cobalt/chromium alloy nanoparticles – because these are created in small amounts when artificial joints wear during use. The research shows – in a lab situation not designed to accurately replicate conditions in the body – that high doses of the CoCr nanoparticles can cause measurable damage to the DNA in human fibroblast cells (cells important in wound healing) across an intact cellular barrier without actually crossing the cellular barrier.

The FDA has thus far been relatively unconcerned about any unique safety issues of nanoscale products under its auspices, and believes that existing standards for safety and efficacy will be adequate for most nanotechnology medical products.  The FDA’s Nanotechnology Task Force published its Report in July 2007 and did not suggest the need for any immediate nano-specific regulatory action, but did recognize that obvious knowledge gaps exist concerning new risks presented by nanomaterials.  The FDA's position has critics. 

It remains to be seen what additional internal processes or regulatory actions, if any, the FDA will pursue to address nanospecific product and safety issues. This is an evolving area of regulatory law and all pharmaceutical, medical device, and health care risk managers and their attorneys must stay closely attuned.

The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.