FDA will be overstretched by need to monitor medical nanotechnology
12 October 2006
Washington, USA. Developments in medical nanotechnology are advancing at
such a rate that the US regulatory body, the Food and Drug Administration is
unlikely to be able to cope with the requirements to monitor them, according
to a new report.
“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 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 (see below)
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
www.nanotechproject/86.
“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
www.nanotechproject.org/83
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