Nanotech Knocks on FDA’s Door

Food & Drug Administration Faces Growing Number of Nanotech Medical Products

WASHINGTON—“Thanks to the promise of nanotechnology, people will benefit from fantastic new prescription drugs and from better ways of getting existing pharmaceuticals into the body for more effective disease treatments. But new nano-enabled drugs and medical devices also place new burdens on an oversight agency that is already stretched extremely thin,” said Project on Emerging Nanotechnologies Director David Rejeski in a presentation today at the Food and Drug Administration’s first major public meeting on regulating products containing nanotechnology materials.

Both in his remarks and in the Project’s written submission – available above – Rejeski stated that “there are currently 130 nano-based drugs and delivery systems and 125 devices of biomedical devices in preclinical, clinical or commercial development—an increase of almost 70 percent just since last year. While FDA already has approved some products with materials in the nanosize range, prospects for future growth in this area—and the burden it will place on the agency’s resources—are striking.”

“The Project on Emerging Nanotechnologies—using information contained in the 2006 Nanomedicine, Device & Diagnostics Report—recently examined just two sets of nanotechnology medical applications: cancer-relevant drugs (total: 77) and drug delivery applications (total: 56). While this was only a very preliminary assessment, the analysis shows the nanotechnology pipeline of medical products is growing and could pose a major challenge to the agency’s resources and expertise in the near future.”

The Project’s submission also highlighted nine currently available nanotechnology drug and drug delivery products already approved for use by FDA. They include:

• Abraxane®: a treatment for advanced forms of breast cancer using “nanoparticles made of the human protein albumin”
• Acticoat®: uses SILVCRYST™ Nanocrystals to create wound dressings that “offer powerful antimicrobial barrier protection”
• Estrasorb®: a topical estrogen therapy product based on a “patented and proprietary micellar nanoparticles drug-delivery platform”

More detailed information on these and other nanotechnology medical products can be found on the Project on Emerging Nanotechnologies website at http://www.nanotechproject/topics/medical/.

“Nanotechnology is emerging rapidly as a transformative technology across virtually every product category FDA regulates,” stated Rejeski. “The stakes are extremely high—in terms of human health benefits, financial investments, and scientific progress. It’s up to FDA, with the strong support of Congress and industry, to ensure that these nanotechnology products are safe. Unless the FDA has the capacity to address potential nanotechnology risks now, public confidence in a host of valuable nanotechnology-based products could be undermined.”

The Project on Emerging Nanotechnologies just released a new report by former FDA Deputy Commissioner for Policy Michael R. Taylor, Regulating the Products of Nanotechnology: Does FDA have the Tools It Needs? This in-depth study of the FDA’s resource and legal capacity to safely regulate nanotechnology products—including dietary supplements, food, cosmetics and drugs—is also available at TBA.