Will the FDA Be Able to Regulate Nanotechnology?
BY ARIELLA P. GOLOMB, MD, OCTOBER 6, 2006
Nanotechonology is clearly making strides in the orthopedic marketplace. The question is, will the FDA will be able to keep up?
Report Claims FDA Not "Nano Ready"
Yesterday, Michael Tayor, an attorney and former Deputy Commissioner for Policy at the FDA, released a report entitled, "Regulating the Products of Nanotechonology: Does FDA Have the Tools It Needs?" Talyor concludes that the FDA is not "nano-ready," lacking the legal tools it needs (particularly in the areas of cosmetics and dietary supplements) and hampered by a lack of resources. The FDA needs adequate funding in order to respond appropriately to available and pipeline products (to build its own expertise, develop safety-testing protocols and detection methods, conduct its own risk research and gather necessary premarket data.) This lack of FDA preparedness may cause potential safety problems to go unnoticed, thereby risking public health and erroding public trust in nanotechnology, as well as impede innovation with lagging regulatory guidance and regulatory reviews. Taylor calls for immediate FDA steps including establishing criteria for determining when a nanoscale materials is new for legal/regulatory and safety evaluation purposes.
The FDA is scheduled to have its first major public meeting on nanotechnology oversight on October 10, 2006 and has established a NanoTechnology Interest Group (NTIG). Also established were multidisciplinary working groups, comprised of FDA staff, with the goal of sharing nanotechnology information and coordinating the review of various product types. The working groups are charged with identifying and defining the regulatory challenges in the various review disciplines and to propose a path forward.
What is Nanotechnology?
According to The Project on Emerging Nanotechnologies (a joint initiative between the Wilson Center and The Pew Charitable Trusts, who published Taylor's report), "Nanotechnology is the ability to measure, see, manipulate, and manufacture things at an atomic and molecular scale, usually between 1 and 100 nanometers. A nanometer is one billionth of a meter; a human hair is roughly 100,000 nanometers wide." There is a signficant market opportunity for nanotechnology. NanoBiotech News reported that there are ~130 nano-based drugs and delivery systems and ~125 medical devices or diagnostic tests in preclinical, clinical or commercial development.
How is nano-technology applied to tissue engineering?
As Dequing Huang, MD, PhD et. al pointed out in their review article "Tendon Tissue Engineering and Gene Transfer: The Future of Surgical Treatement" published in The Journal of Hand Surgery from May-June of this year, nanometer-sized materials can influence cell behavior. The tissue's extracellular matrix's (ECM) porous microstructure is made of a nanometer-sized collagen fibrils. The cells organize around the ECM fibers, and the ECM influences tissue regeneration. Cell culture studies have confirmed that various types of cells (including osteoblasts, fibroblasts, bone-marrow-derived MSCs and muscle cells) can adhere to and proliferate on these nanofiber matrices. After the nanofiber matrices are fabricated from electrospinning or other techniques, their mechanical integrity can be further enchanced by modification into tubes or other shapes.
Scanning electron micrograph of a polyphosphazene nanofiber scaffold with cells (c) on nanofibers (p) after 3 in culture. Found in: Dequing Huang, MD, PhD et. al, "Tendon Tissue Engineering and Gene Transfer: The Future of Surgical Treatement" published in The Journal of Hand Surgery, May-June 2006
Orthopedic nanotechnology applications
Here are some companies we've previously highlighted on our blog who have worked and are working on implementing orthopedic nanotechnology applications:
-Earlier this week Spire Corporation announced that it was awarded a grant by the National Institutes of Health-National Institute of Arthritis and Muskuloskeletal and Skin Diseases (NIH-NIAMS) to develop a new type of nanotechnology coating for wear-resistant orthopedic devices with specific spinal implant applications.
-In April of this year, Nano Interface Technology, Inc. (NITI), which specializes in developing bioactive nanotechnology coatings, announced collaboration agreements with Naval Research Laboratory (NRL) for their orthopedic implant coating technology and Virginia Commonwealth University (VCU) to address innovative dental applications.
-Last year Competitive Technologies (a servicing and licensing company that identifies, develops, and commercializes innovative technologies in the areas of electronics, nanotechnology, and physical sciences) exclusively licensed the manufacture and sale of its nanotechnology bone material for spinal applications to Soteira.
-Also last year, pSivida, a nantotechnology company based in Australia, raised $4.2 million via a private investment of public equity (PIPE).
-Angstrom Medica, Inc.'s NanOss(TM) Engineered synthetic bone utilizes nanotechnology, calcium and phosphate to manipulate and mimic, at the molecular level, structure of bone. Information on this company is included within HealthpointCapital's 2005 Biomaterials report.
