FDA Nanotechnology Regulatory Science Program Science Board Presentation August 2010

Transcription

1 FDA Nanotechnology Regulatory Science Program Science Board Presentation August 2010 FDA Nanotechnology Task Force Carlos Peña, PhD Office of the Commissioner & Subhas Malghan, PhD Center for Devices and Radiological Health 1

2 Outline Present FDA s Nanotechnology Regulatory Science Program The Context Why important to FDA Ongoing Activities at FDA, US Agencies, Internationally Regulatory Science Priorities Proposed 2011 Nanotechnology Research Program Areas CORES Program for Product Characterization, Safety Enhancing Laboratory Regulatory Science Capacity Staff Training and Development Questions, Comments

3 Why should FDA focus on Nanotechnology? Increasingly used in products regulated by FDA Drugs, medical devices, cosmetics, dietary supplements Near term/future applications-food applications, targeted medical therapies, device materials FDA plays key regulatory role for Nanotechnology National priority for the US National Nanotechnology Initiative OSTP Signature Initiatives Part of US economic development strategy for science and technology 3

4 Examples of FDA Regulated Product Areas Foods All interstate domestic and imported, including produce, fish, shellfish, shell eggs, milk (not meat or poultry) Bottled water Infant formula Food additives Food packaging Colors Cosmetics Dietary Supplements Tobacco Products Animal Foods and Feeds Pharmaceuticals Human Animal Tamper resistant packaging Medical devices Radiation emitting electronic products Biologics 4

5 NIST DOD NIH OSTP OMB NSF DOE FDA NASA USDA NIOSH DOS National Nanotechnology Initiative Collaborative, Multi-agency, Cross-cut Program Among 25 Federal agencies, 15 of which have specific nanotechnology budgets USDA FS EPA DOTr DOT Funds R&D to advance understanding and control of matter at nanoscale toward: National economic benefit NRC USPTO ITIC National and homeland security Improved quality of life DOL USGS DOJ DOC BIS DHS CPSC ITC DOEd 5

6 Ongoing Nanotechnology FDA Activities Participation in NNI Subcommittees and Working Groups NSET, NEHI, GIN PCAST review of NNI NNI Strategic Plan Workshops Coordination within the Agency FDA Nanotechnology Task Force (est. 2006) Cross Center groups to assess nanotechnology science and regulatory issues Nanotechnology research across FDA Centers Communication with International Organizations 6

7 One Example of Collaboration 7

8 Nanotechnology Task Force Report Outcomes Science Recommendations Policy Recommendations 8

9 2007 FDA Nanotechnology Task Force Report Science Recommendations Need to understand biological interaction and properties of nanomaterials. Important to promote measurement and detection of nanomaterials. Critical need to evaluate specific products and their review categories. Must continue to build in-house scientific expertise. Value in the regulatory coordination for products containing nanomaterials. 9

10 What does FDA Need to Do? Keep pace with rapid growth of nanotechnology and evolving state of scientific knowledge Prepare for the types of products in the near future Understand biological interactions of regulated products that contain this technology Specifically: Understanding of interactions of nanoscale materials with biological systems; and Adequacy of testing approaches for assessing safety, effectiveness, and quality of products containing nanoscale materials. 10

11 How Will FDA Do It? Agency coordination Ongoing research programs Continue to develop regulatory policies Regulatory Science Nanotechnology Initiative $7.3M in OMB budget Coordinated approach to enhance FDA s Regulatory Science needs for nanotechnology 11

12 Summary-FDA Regulatory Science Activities Need to understand properties and biological interaction of nanoscale material when used across FDA-regulated product areas Support and increase laboratory science capabilities, expertise, within FDA and in collaboration with others across the government, and other stakeholders Need to do so in a timely, purposeful fashion based on regulatory need 12

13 FY2011 FDA Science Budget Initiative and Request 1st explicit and dedicated support of science infrastructure and capacity in FDA s budget ~$25 million across agency Major components Nanotechnology, Critical Path, Science Leadership, and others Emerging science Nanotechnology review & safety $7.33 million 13

14 Key Components of 2011 Nanotechnology Regulatory Science Initiative CORES Program Collaborative Opportunities for Research Excellence in Science Enhance external and cross-center activities Support external research programs Laboratory Capacity to Assess Nanotechnology Products Equip Core Laboratory Facilities Training and staff development 14

15 Collaborative Opportunities for Research Excellence in Science (CORES) Objectives Support for research projects in nanotechnology regulatory science priority areas Emphasis on inter-agency projects Enhanced coordination through NNI CPSC, EPA, NIH, NIST, NSF, DARPA Support for joint FDA-Academia projects Enhanced safety, toxicity programs Development of internal FDA research priorities and cross-center projects Funding process to be public and transparent 15

16 CORES Program Research Priorities Characterization of Nanomaterials Define physical/chemical characteristics of nanomaterials that affect potency Define characteristics that impact safety Biocompatibility Interaction with biological processes in tissues, fluids Pharmacokinetics Safety Toxicokinetics In vitro toxicity test methods (e.g. cytotoxicity, genotoxicity) In vivo toxicity tests (e.g. 90-day, 2-yr) 16

17 CORES Program Grant Mechanism Review Process Develop Criteria for Review Application to Targeted Topic Areas Probability for Success Collaboration Assemble Review Committee FDA Staff Science Board Members Additional Subject Matter Experts 17

18 Nanotechnology Research Laboratory Science Core Facilities: Requirements Must have appropriate... Equipment Personnel and appropriate... Methods for.. Characterization Biocompatibility and toxicity 18

19 Nanotechnology Research Laboratory Core Facilities: Locations White Oak Campus and Surrounding Region - CBER - CDER - CDRH - CFSAN - CVM Jefferson Laboratories - NCTR - ORA 19

20 Ongoing FDA Activities in Staff Training & Professional Development Invited Expert Presentations Product Specific Agency Wide Day Long Workshops FDA Staff International Experts Meeting Center Specific Activities 20

21 Target Audiences Three types of staff with different needs Review Staff Research Staff Field Staff 21

22 Suggested Topics and Modules Regulatory Backgrounder Module Regulatory Frameworks Legislative Regimes Agency Guidance Product Areas Information Basic Science Module Scientific Theory Classes of Nanomaterials Phys, Chem Properties Material Structure, Synthesis Biological Characterization Occupational Safety Applied Sciences Module Applications Nanomedicine Novel Foods Diagnostics/Therapeutics Premarket Testing Toxicity, Biocompatibility Trial Design Product Case Study Journal Reviews Ethical, Legal, and Societal Implications Module Characterization Module Product Characterization Comparison to Bulk Materials Product Case Study Manufacturing Facility Module Technologies, Testing, Stability Pre/Approval Inspections Occupational Safety 22

23 Proposed Enhanced Program in Staff Training & Professional Development Course Development Process Fall 2010 Winter 2010 Spring 2011 Fall 2011 Select Lecturers Develop Syllabus Registration /Facilities Regulatory Module Basic Science Module Characterization Module Applied Module ELSI Module Manufacture Module Program Review Invite Lecturers Develop Syllabus-Yr 2 23

24 FDA s Nanotechnology Regulatory Research Program Anticipated Roll Out (Operating Funds) Year 1 Laboratory Core Facilities Staff Training and Professional Development CORES Program Year 2+ CORES Program Staff Training and Professional Development Laboratory Core Facilities 24

25 Summary- Nanotechnology Research Program Overall plan to further advance nanotechnology relevant regulatory science Outline of proposed regulatory science program in nanotechnology - CORES (Collaborative Opportunities for Research Excellence in Science) program - Enhance scientific and laboratory research facilities - Staff training and professional development 25

26 Briefing Materials National Nanotechnology Initiative Summary National Nanotechnology Initiative Supplement to the President s FY2011 Budget FDA Nanotechnology Task Force Report (2007) FDA Nanotechnology Research Projects ( ) FDA Nanotechnology Publications Listing ( ) FDA Nanotechnology Website Front Page Accessible at: Nanotechnology/default.html 26

27 Acknowledgements Office of the Commissioner Office of the Commissioner Center for for Biologics Evaluation & Research Center for for Devices & Radiological Health Center for for Drug Evaluation & Research Center for for Food Safety & Applied Nutrition Center for Tobacco Products Center for Tobacco Products Center for Veterinary Medicine Center for Veterinary Medicine Office of the Chief Counsel Office of the Chief Counsel Office of Regulatory Affairs Office of Regulatory Affairs National Center for for Toxicological Research 27

28 For Discussion with the Science Board Overall FDA plan to further advance regulatory science program in Nanotechnology - Initiate CORES (Collaborative Opportunities for Research Excellence) Program - Enhance Laboratory capacity to assess nanotechnology products and their safety - Promote staff development and training 28

29 Thank you Questions or Comments? 29