[Congressional Record Volume 157, Number 149 (Thursday, October 6, 2011)]
[Senate]
[Pages S6332-S6334]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. PRYOR (for himself and Mr. Cardin):
S. 1662. A bill to amend the Federal Food, Drug and Cosmetic Act to
establish a nanotechnology regulatory science program; to the Committee
on Health, Education, Labor, and Pensions.
Mr. PRYOR. Mr. President, I rise today with Senator Cardin to
introduce the Nanotechnology Regulatory Science Act of 2011 which will
authorize a program of regulatory science by the U.S. 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 public that nanotechnology-based products are both safe and
efficacious. The Nanotechnology Regulatory Science Act of 2011 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, cosmetics, sunscreens and food
additives must be based on scientific knowledge and data about each
specific technology and product. Without a robust regulatory science
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.
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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 nanomaterials in drugs, devices, biologics, cosmetics, food,
and over-the-counter products. This will require the FDA to devote more
of its regulatory attention to nanotechnology based products.
The FDA has already begun to devote some resources to the
understanding of the human health effects and safety of nanotechnology.
The FDA has established a Nanotechnology Core Facility at the National
Center for Toxicological Research in Jefferson Arkansas. In August,
Arkansas Governor Beebe and FDA Commissioner Hamburg signed a
memorandum understanding creating a Virtual Center of Excellence in
regulatory science pertaining to nanotechnology. Under the agreement,
the state's five research universities--the University of Arkansas,
Fayetteville; the University of Arkansas for Medical Sciences; the
University of Arkansas at Little Rock; the University of Arkansas at
Pine Bluff, and Arkansas State University--will work with the NCTR to
establish a nanotechnology collaborative research program dealing
specifically with toxicity. In addition, UAMS will offer a Master's
degree and a certification program in regulatory science.
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.
In conclusion, the Nanotechnology Regulatory Science Act of 2011 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. 1662
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 Regulatory
Science Act of 2011''.
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. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.
``(a) In General.--Not later than 180 days after the date
of enactment of the Nanotechnology Regulatory Science Act of
2011, the Secretary, in consultation with the Secretary of
Agriculture, shall establish within the Food and Drug
Administration a program for the scientific investigation of
nanomaterials included or intended for inclusion in products
regulated under this Act, 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
nanomaterials interactions with biological systems and on
specific nanomaterials of concern to Food and Drug
Administration;
``(2) in cooperation with other Federal agencies, develop
and organize information using databases and models that will
facilitate the identification of generalized principles and
characteristics regarding the behavior of classes of
nanomaterials with biological systems;
``(3) promote intramural Food and Drug 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 nanomaterials;
``(5) collect, synthesize, interpret, and disseminate
scientific information and data related to the interactions
of nanomaterials with biological systems;
``(6) build scientific expertise on nanomaterials within
such Administration, including field and laboratory
expertise, for monitoring the production and presence of
nanomaterials in domestic and imported products regulated
under this Act;
``(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, acting through the Commissioner
of Food and Drugs, 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
activities by the Food and Drug Administration and other
departments and agencies participating in the National
Nanotechnology Initiative; and
``(C) develop intramural Food and Drug 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 15, 2014, the
Secretary shall submit to Congress 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
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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 is authorized
to be appropriated to carry out this section, $15,000,000 for
fiscal year 2013, $16,000,000 for fiscal year 2014, and
$17,000,000 for fiscal year 2015. Amounts appropriated
pursuant to this subsection shall remain available until
expended.''.
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