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Disagreement about FDA nanotech oversight

Advocacy groups and drug firms face off at the first open meeting of the FDA Nanotechnology Task Force

By | October 11, 2006

The U.S. Food and Drug Administration (FDA) needs greater authority and financial resources to properly regulate nanotechnology materials in drugs, biologics, food, cosmetics and other products, many academics and representatives of environmental and consumer groups said at the first open meeting of the FDA Nanotechnology Task Force on Tuesday. Representatives of business groups and drug companies generally disagreed, saying FDA's existing regulatory authority is adequate to deal with the emerging field, despite the fact that there are currently no FDA regulations that specifically address nanomaterials. The nanotechnology task force was formed in August to help determine how the agency should regulate nanomaterials, especially for safety. Nearly 40 presenters and 300 observers attended the open meeting on the campus of the National Institutes of Health in Bethesda, MD. The nanotechnology industry is expected to grow to $2.6 trillion in manufactured goods by 2014, according to Lux Research. Last year, nanotech drug delivery systems alone accounted for $980 million in sales, 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 new report. More than 4,000 nanotech-related patents have been issued and another 2,700 are reportedly pending before the U.S. Patent and Trademark Office, several speakers said. Despite this, few studies have been done on how nanomaterials penetrate and alter cellular systems and accumulate in and affect the environment. The Federal government has requested $44.1 million this year for environmental, health, and safety (EHS) research for all the agencies in the National Nanotechnology Initiative. But that represents less than four percent of the overall nanotech-related budget of $1.3 billion. "We need to be smart about how we spend our limited resources," Celia Merzbacher, assistant director of the White House Office of Science and Technology Policy, said at the meeting. Others said that the funding is inadequate to address the challenge, noting that FDA is not slated to receive any EHS research funds. Some suggested that industry should be encouraged to take on much of the research needed to close the current knowledge gaps. "There are knowledge gaps in characterization, mechanisms, and toxicokinetics," noted Philippe Martin, principal administrator for Health and Consumer Protection at the European Commission. Delara Karkan, associate director of Health Canada's Center for the Evaluation of Biotherapeutics and Radiopharmaceuticals, agreed. "There are gaps in the science," she said. "How can we clarify and encourage industry to assess the health and safety of these products?" Much of the discussion surrounded use of nanomaterials in cosmetics and personal care products, industries over which FDA has relatively little regulatory authority compared to drugs and medical devices. Citing toxicological concerns about nanoscale titanium dioxide and zinc oxide in sunscreens, several representatives of consumer and environmental groups called for a moratorium on such products until more comprehensive safety studies have been performed. "In vitro tests of skin cells are not adequate to determine where these particles go in the body," said John Balbus, director of health programs at the advocacy group Environmental Defense. However, representatives of drug and medical device companies said FDA's current regulatory mechanisms are adequate to oversee development of nanomaterial drug delivery systems and therapies. Examples cited included nanoparticle albumin-bound platforms for targeted delivery of cancer drugs like paclitaxel and ligand-targeted emulsions for MRI. "We just take existing products that have generated safety profiles and [use] them at much lower levels and increase the safety of the product," said Phillip Buckler, vice president of Kereos, Inc., a manufacturer of targeted therapeutics and molecular imaging agents. "The FDA already has in place a comprehensive regulatory system," said Matthew P. Jaffe, an attorney speaking on behalf of the United States Council for International Business. "We strongly encourage FDA to regulate applications that use nanotechnology using the same guiding scientific principles that have already allowed this agency to protect, promote, and improve public health," he said. "The science does not yet mandate draconian action," said Martin A. Philbert, a toxicology professor and executive director of the Center for Risk Science and Communication at the University of Michigan School of Public Health. He cited research indicating that toxicity may come from arsenic and other metals used in fabricating nanomaterials, rather than from the nanoscale itself, and that coatings of biocompatible materials can significantly reduce toxicity. "There is no need to panic," Philbert counseled. "At present, the benefits of nanoscale materials greatly outweigh the risks." Ted Agres tagres@the-scientist.com Links within this article: P. Lin, "Nanotechnology's Dilemmas," The Scientist, Dec. 5, 2005 http://www.the-scientist.com/article/display/15892 FDA Nanotechnology Public Meeting www.fda.gov/nanotechnology FDA Nanotechnology Task Force http://www.fda.gov/bbs/topics/NEWS/2006/NEW01426.html V. Colvin, "Sustainability for Nanotechnology," The Scientist, Aug. 30, 2004 http://www.the-scientist.com/article/display/14901 Lux Research http://www.luxresearchinc.com/ M.R. Taylor, "Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?" Woodrow Wilson International Center for Scholars, Project on Emerging Technologies, Washington DC, Oct. 5, 2006. http://nanotechproject.org/83 S. Maebius, "Navigating Nanotechnology Patent Thickets," The Scientist, Dec. 6, 2004 http://www.the-scientist.com/article/display/15138 K. Grens, "Nanotechnology report urges better safety standards," The Scientist 9/26/06 http://www.thescientist.com/news/display/24910/ Environmental Defense http://www.environmentaldefense.org/home.cfm Kereos http://www.kereos.com/ United States Council for International Business http://www.uscib.org Center for Risk Science and Communication http://www.sph.umich.edu/riskcenter

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