Nanotechnology - USDA - 18 Nov 2002

REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC

HEALTH

FOOD AND DRUG ADMINISTRATIONNorris E. Alderson, Ph.D.

Senior Associate Commissioner for Science

Nanotechnology - USDA - 18 Nov 2002

FDA REGULATES

• 20 percent of the consumer purchases• $50 billion of medical R&D• 8 million import shipments/year• Food, drugs, biologicals, devices, cosmetics,

blood• Counter terrorism products

Nanotechnology - USDA - 18 Nov 2002

FDA’S PUBLIC HEALTH MISSION

• Safety

• Efficacy

• Good Manufacturing controls

• Risk analysis

• Be a force in counter-terrorism

Nanotechnology - USDA - 18 Nov 2002

FDA ORGANIZATION

• Center for Biologics Evaluation and Research• Center Drug Evaluation and Research• Center for Devices and Radiological Health• Center for Food Safety and Applied Nutrition• Center for Veterinary Medicine• Office of Regional Operations• National Center for Toxicological Research

Nanotechnology - USDA - 18 Nov 2002

PUBLIC HEALTH IMPLICATIONS FOR NANOTECHNOLOGY

• New materials and manufacturing processes• All FDA regulated areas are likely affected

– drugs, medical devices, biologicals, food

• The science is new to the Agency– Risk management is our job

• Education of the Public will define its acceptance

Nanotechnology - USDA - 18 Nov 2002

NATIONAL NANOTECHNOLOGY INITIATIVE

• Examples of fundamental research that will be regulated by FDA– Biological assembly of nanostructures– Using DNA molecules to construct nanoscale

devices– Artificial genetic system– Modeling and simulation of biological ion

channels to cure diseases– Nanoscale film serves as molecular filter

Nanotechnology - USDA - 18 Nov 2002

NANOTECHNOLOGY AND COMMERCIALIZATION OF PUBLIC

HEALTH PRODUCTS

• Education & training of FDA• Education of the Public – Developing the public

perception• Education and training of industry sectors unfamiliar with

FDA• Demonstrate the safety of products• Demonstrate the efficacy of products• Establishment of standards of manufacturing,

performance, and approval• Risk analysis and management

Nanotechnology - USDA - 18 Nov 2002

CHALLENGES!!

• New technology – Unknown risks

• Education – A bad job here can minimize the utility

• Stakeholder involvement– Early involvement of all parties– Risk communication

• FDA guidance development – Help us.