[Congressional Record Volume 156, Number 7 (Thursday, January 21, 2010)]
[Senate]
[Pages S123-S125]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. PRYOR (for himself and Mr. Cardin):
S. 2942. A bill to amend the Federal Food, Drug, and Cosmetic Act to
establish a nanotechnology program; to the Committee on Health,
Education, Labor, and Pensions.
Mr. PRYOR. Mr. President, I rise today with Senator Cardin to
introduce the Nanotechnology Safety Act of 2010 which will authorize a
program of scientific investigation by the Food and Drug Administration
on nanotechnology-based medical and health products.
Nanotechnology holds great promise to revolutionize the development
of new medicines, drug delivery, and orthopedic implants while holding
down the cost of health care. However, Congress and the FDA must assure
the
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public that nanotechnology-based products are both safe and
efficacious. The Nanotechnology Safety Act of 2010 will enable the FDA
to properly study how nanomaterials are absorbed by the human body, how
nanomaterials designed to carry cancer fighting drugs target and kill
tumors, and how nanoscale texturing of bone implants can make a
stronger joint and reduce the threat of infection.
Nanotechnology, or the manipulation of material at dimensions between
1 and 100 nanometers, is a challenging scientific area. To put this
size scale in perspective, a human hair is 80,000 nanometers thick.
Nanomaterials have different chemical, physical, electrical and
biological characteristics than when used as larger, bulk materials.
For example, nanoscale silver has exhibited unique antibacterial
properties for treating infections and wounds. Nanomaterials have a
much larger ratio of surface area to mass than ordinary materials do.
It is at the surface of materials that biological and chemical
reactions take place, and so we would expect nanomaterials to be more
reactive than bulk materials.
The novel characteristics of nanomaterials mean that risk assessments
developed for ordinary materials may be of limited use in determining
the health and public safety of products based on nanotechnology.
The FDA needs the tools and resources to assure the public that
nanotechnology-based medical and health products are safe and
effective. The development of a regulatory framework for the use of
nanomaterials in drugs, medical devices, and food additives must be
based on scientific knowledge and data about each specific technology
and product. Without a robust scientific framework there is no way to
know what data to collect. More than a dozen material characteristics
have been suggested even for relatively simple nanomaterials. Without
better scientific knowledge of nanomaterials and their behavior in the
human body, we do not know what data to collect and examine.
In 2007, the FDA Nanotechnology Task Force published a report
analyzing the FDA's scientific program and regulatory authority for
addressing nanotechnology in drugs, medical devices, biologics, and
food supplements. A general finding of the report is that nanoscale
materials present regulatory challenges similar to those posed by
products using other emerging technologies. However, these challenges
may be magnified because nanotechnology can be used to make almost any
FDA-regulated product. Also, at the nanoscale, the properties of a
material relevant to the safety and effectiveness of the FDA-regulated
products might change.
The Task Force recommended that the FDA focus on improving its
scientific knowledge of nanotechnology to help ensure the agency's
regulatory effectiveness, particularly with regard to products not
subject to premarket authorization requirements.
The FDA has already reviewed and approved some nanotechnology-based
products. In the coming years, they expect a significant increase in
the use of nanoscale materials in drugs, devices, biologics, cosmetics,
and food. This will require the FDA to devote more of its regulatory
attention to nanotechnology based products.
Let me talk for a few minutes about two areas where nanotechnology is
already being applied to health care.
The early detection of cancer and multifunctional therapeutics.
The early detection of cancer can result in significant improvement
in human health care and reduction in cost. Nanotechnology offers
important new tools for detection where existing and more conventional
technologies may be reaching their limits. The present obstacle to
early detection of cancer lies in the inability of existing tools to
detect these molecular level changes directly during early phases in
the genesis of a cancer. Nanotechnology can provide smart contrast
agents and tools for real time imaging of a single cell and tissues at
the nanoscale.
Nanotechnology promises a host of minimally-invasive diagnostic
techniques and much research is aimed at ultra-sensitive labeling and
detection technologies. In the in vitro area, nanotechnology can help
define cancers by molecular signatures denoting processes that reflect
fundamental changes in cells and tissues that lead to cancer. Already,
investigators have developed novel nanoscale in vitro techniques that
can analyze genomic variations across different tumor types and
distinguish normal from malignant cells.
In the in vivo area, one of the most pressing needs in clinical
oncology is for imaging agents that can identify tumors that are far
smaller than is possible with today's technology. Achieving this level
of sensitivity requires better targeting of imaging agents and
generation of a larger imaging signal, both of which nanoscale devices
are capable of accomplishing.
Perhaps the greatest near-term impact of multifunctional therapeutic
compounds will come in the area of tumor targeting and cancer
therapies. Nanotechnology can be used to develop new methods of drug
delivery that better target selected tissues and cells, and to improve
on the efficiency of drug activity in the cytoplasm or nucleus. Drug
delivery applications will provide a solution to solubility problems,
as well as offer intracellular delivery possibilities.
The introduction of nanotechnology to multifunctional therapeutics is
at an early stage of development. The delivery of nanoscale
multifunctional therapeutics could permit very precise site specific
targeting of cancer cells. More sophisticated ``smart'' systems for
drug delivery still have to be developed that sense and respond to
specific chemical agents and are tailored to each patient.
Multifunctional therapeutic devices need to be developed that
simultaneously detect, diagnose, treat and monitor response to the
therapy. For example, various nanomaterials can be made to link with a
drug, a targeting molecule and an imaging agent to seek out cancers and
release their payload when required.
The FDA has already begun to devote some resources to the
understanding of the human health effects and safety of nanotechnology.
It has established a Nanotechnology Core Facility at the FDA's
Jefferson Arkansas Laboratories. Combining the expertise of the
National Center for Toxicological Research and the Arkansas Research
Laboratory, which is part of the FDA Office of Regulatory Affairs, this
new Nanotechnology Core Facility will support nanotechnology toxicity
studies, develop analytical tools to quantify nanomaterials in complex
matrices, and develop procedures for characterizing nanomaterials in
FDA-regulated products.
In conclusion, the Nanotechnology Safety Act of 2010 will provide the
FDA the authority necessary to scientifically study the safety and
effectiveness of nanotechnology-based drugs, delivery systems, medical
devices, orthopedic implants, cosmetics, and food additives regulated
by the agency. This bill is a sound investment on the promise of
nanotechnology to improve human health and reduce costs in the 21st
Century.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2942
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Nanotechnology Safety Act of
2010''.
SEC. 2. NANOTECHNOLOGY PROGRAM.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 1011. NANOTECHNOLOGY PROGRAM.
``(a) In General.--Not later than 180 days after the date
of enactment of the Nanotechnology Safety Act of 2010, the
Secretary of Health and Human Services, in consultation with
the Secretary of Agriculture, shall establish within the Food
and Drug Administration a program for the scientific
investigation of nanoscale materials included or intended for
inclusion in FDA-regulated products, to address the potential
toxicology of such materials, the effects of such materials
on biological systems, and interaction of such materials with
biological systems.
``(b) Program Purposes.--The purposes of the program
established under subsection (a) shall be to--
``(1) assess scientific literature and data on general
nanoscale material interactions with biological systems and
on specific nanoscale materials of concern to Food and Drug
Administration;
``(2) develop and organize information using databases and
models that will enable
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the formulation of generalized principles for the behavior of
classes of nanoscale materials with biological systems;
``(3) promote intramural Administration programs and
participate in collaborative efforts, to further the
understanding of the science of novel properties at the
nanoscale that might contribute to toxicity;
``(4) promote and participate in collaborative efforts to
further the understanding of measurement and detection
methods for nanoscale materials;
``(5) collect, synthesize, interpret, and disseminate
scientific information and data related to the interactions
of nanoscale materials with biological systems;
``(6) build scientific expertise on nanoscale materials
within such Administration;
``(7) ensure ongoing training, as well as dissemination of
new information within the centers of such Administration,
and more broadly across such Administration, to ensure
timely, informed consideration of the most current science;
``(8) encourage such Administration to participate in
international and national consensus standards activities;
and
``(9) carry out other activities that the Secretary
determines are necessary and consistent with the purposes
described in paragraphs (1) through (8).
``(c) Program Administration.--
``(1) Program manager.--In carrying out the program under
this section, the Secretary shall designate a program manager
who shall supervise the planning, management, and
coordination of the program.
``(2) Duties.--The program manager shall--
``(A) develop a detailed strategic plan for achieving
specific short- and long-term technical goals for the
program;
``(B) coordinate and integrate the strategic plan with
investments by the Food and Drug Administration and other
departments and agencies participating in the National
Nanotechnology Initiative; and
``(C) develop intramural Administration programs,
contracts, memoranda of agreement, joint funding agreements,
and other cooperative arrangements necessary for meeting the
long-term challenges and achieving the specific technical
goals of the program.
``(d) Reports.--Not later than March 1, 2012 and March 1,
2014, the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives a report on the program carried out under
this section. Such report shall include--
``(1) a review of the specific short- and long-term goals
of the program;
``(2) an assessment of current and proposed funding levels
for the program, including an assessment of the adequacy of
such funding levels to support program activities; and
``(3) a review of the coordination of activities under the
program with other departments and agencies participating in
the National Nanotechnology Initiative.
``(e) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$25,000,000 for each of fiscal years 2011 through 2015.
Amounts appropriated pursuant to this subsection shall remain
available until expended.''.
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