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Statements on Introduced Bills and Joint Resolutions

Floor Speech

By:
Date:
Location: Washington, DC

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.

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.


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