 Roger Schillerstrom |
The US Food and Drug Administration (FDA) appears to be taking a cautious, deliberative approach as it approaches the myriad of scientific and regulatory issues involving nanobiotechnology and nanomedicine. After nearly a year of study, the FDA’s Nanotechnology Task Force is merely recommending the agency study the matter more fully and consider developing guidance for industry to assess the benefits and risks of drugs and medical devices using nanotechnology.
The report, issued in July, says the FDA should improve its scientific knowledge about nanoscale materials and determine whether it has the necessary tools to describe and evaluate their use. The report stops well short of recommending any specific regulatory actions, such as mandatory labeling, as many consumer and environmental groups have urged.
The FDA Nanotechnology Task Force was formed in August, 2006, to help determine to what extent the agency might regulate nanomaterials, especially for safety. Due to their small size and high ratio of surface area to volume, nanomaterials (typically between 1 to 100 nanometers in size) often display surprisingly different chemical and physical properties than do their bulk counterparts. Potential uses are far-ranging, from novel drug delivery systems and medical products to innovations in food packaging and cosmetics.
Currently FDA has no distinct regulatory pathway for evaluating and approving products made with nanoscale materials. The uncertain nature of nanotechnology means the FDA should obtain more data on the biological effects and interactions of these materials and also evaluate the adequacy of current testing approaches to assess safety, efficacy, and quality, the task force suggests.
“Nanotechnology holds enormous potential for use in a vast array of products,” says FDA Commissioner Andrew von Eschenbach. “Recog-nizing 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,” he says in endorsing the task force recommendations.
The nanotechnology industry is expected to grow to $2.6 trillion in manufactured goods by 2014, according to Lux Research, a New York-based consultancy. Last year, $12.4 billion was invested in nanotech R&D worldwide and more than $50 billion worth of nano-enabled products was sold, Lux reported. Nanotech drug delivery systems alone accounted for $980 million in sales in 2005 with 130 nano-based drugs and delivery systems and 125 nano-based devices or diagnostic tests in various stages of clinical development, according to a report by the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars.
The FDA task force says the agency’s existing authority over drugs, biologicals, medical devices, and food and color additives already allows it to request and obtain detailed specific information to review the safety and effectiveness of nanomaterials. For instance, FDA can provide guidance to manufacturers about when nanoscale ingredients might require additional data, change the product’s regulatory status or pathway, or merit taking special steps to address safety or quality issues. But for products not subject to premarket authorization, such as dietary supplements and cosmetics, the FDA’s oversight capacity is “less comprehensive,” the report notes.
More than 4,000 nanotech-related patents have been issued and at least 2,700 more are pending before the United States Patent and Trademark Office. Despite this, few studies have been done on how nanomaterials penetrate and alter cellular systems and accumulate in and affect the environment. The US government is seeking $58.6 million next year for environmental, health, and safety (EHS) research for all the 26 Federal agencies involved in the National Nanotechnology Initiative (NNI). But this represents only 4 percent of the Federal government’s Fiscal 2008 nanotech-related budget request of $1.4 billion, a 13% increase over 2007.
Internationally, nanotech efforts also continue to grow. Japan has a $1.1 billion program underway and the European Union has set aside $4.5 billion for nanoscience research. R&D efforts in nanomedicine include targeted drug delivery mechanisms, therapeutics, gene delivery vectors, sensors and molecular imaging, diagnostics, and analytical tools.
A couple of recent examples:
• Johns Hopkins University researchers have developed nanoscale semi-permeable magnetocapsules made from a matrix of seaweed extract and iron capable of preventing insulin-cell transplant rejection in diabetics. In studies in mice and swine, the 350-?m capsules had pores large enough to allow insulin to pass through but small enough to prevent antibodies directed against ß-cells from the pancreas from entering and attacking.
• University of Michigan Medical School scientists recently developed a nanoemulsion nasal drug delivery system for an anthrax vaccine that makes it more effective and easier to administer in animal models. The nanoemulsion is made up of water, soybean oil, alcohol, and surfactant emulsified to create droplets 200 to 300 nanometers in size. The oil particles are small enough to ferry a key anthrax protein inside the nasal membranes, initiating an immune system response.
Numerous nanobiotech companies are developing products. Kereos Inc., St. Louis, Mo., is developing targeted molecular imaging agents and therapeutics to detect and treat cancer and cardiovascular disease. Kereos is collaborating with Bristol-Myers Squibb Medical Imaging, North Billerica, Mass., to develop and commercialize cardiovascular molecular imaging agents using MRI. “We just take existing products that have generated safety profiles and are using them at much lower levels and increase the safety of the product,” Kereos Vice President Phillip Buckler told a meeting of the FDA task force last year.
Universities are also racing to embrace the nanobiotech trend. The National Science Foundation and National Cancer Institute are funding four academic programs, including a nanopharmaceutical engineering and science program at Rutgers University, Piscataway, N.J.; an integrative nanoscience and microsystems program at the University of New Mexico, Albuquerque; a nanomedical science and technology program at Northeastern University in Boston; and a joint program with the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle, and the Pacific Northwest National Laboratory in Richland, Wash.
Over the past two years, the National Institutes of Health (NIH) has established a national network of eight Nanomedicine Development Centers to support the NIH Nanomedicine Roadmap Initiative. These collaborative centers involve teams of biologists, physicians, mathematicians, engineers, and computer scientists. Initial research is directed at learning more about the physical properties of intracellular structures with hopes of applying that knowledge to nanomaterials.
Contributing editor Ted Agres, MBA, is a veteran science writer in Washington, DC. He writes frequently about the policy, politics, and business aspects of life sciences.
About the Author
Contributing editor Ted Agres, MBA, is a veteran science writer in Washington, DC. He writes frequently about the policy, politics, and business aspects of life sciences.
This article was published in Drug Discovery & Development magazine: Vol. 10, No. 10, October, 2007, pp. 8-10.
Filed Under: Drug Discovery
