FDA’s Approach to Regulation of Nanotechnology Products Ritu Nalubola, Ph.D. Senior Policy Advisor Office of the Commissioner U.S. Food and Drug Administration January 2014 1
Briefly today . . . • Overarching approach to regulation and oversight – Policy Considerations – Agency-level draft guidance to industry – Relevant USG and international context • Agency’s current thinking on product -specific issues – Product-specific draft guidances to industry • Advancing regulatory science • Regulatory cooperation activities 2
What does FDA do? FDA is responsible for: • Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices are safe and effective • Protecting the public from electronic product radiation • Assuring cosmetics and dietary supplements are safe and properly labeled • Regulating tobacco products • Advancing the public health by helping to speed product innovations 3
Nanomaterials and FDA-Regulated Products • Drugs (NMEs, new formulations, imaging agents) • Medical devices (in contact/not in contact with human body ) • Tissue engineering, biological products (blood substitutes, virus-like particle vaccines) • Food (food contact substances, packaging) • Cosmetics • Nutritional supplements 4
Policy Considerations • Regulating in the face of evolving scientific evidence • Determining effects on safety, effectiveness, and/or regulatory status of products • Assessing whether current safety assessment and testing methods are sufficiently robust and flexible • Role of post-market surveillance • Considering the need for any changes in regulatory frameworks • Providing regulatory clarity to industry and consumers • Regulatory cooperation with partners 5 5
U.S. Government Policy • Executive Order 13563 , January 2011 • Memoranda to Heads of Departments -- Provide a general framework for regulation and oversight of emerging technologies and nanotechnology - Principles for regulation and oversight of Emerging Technologies, March 2011 http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles- for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf - Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, June 2011 http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology- regulation-and-oversight-principles.pdf 6 6
FDA’s Regulatory Policy Approach (1) http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm3011 14.htm • Protect and promote public health • Risk-based regulatory approach based on sound science • FDA does not categorically judge all nanotechnology products as inherently benign or harmful • Product-specific approaches consistent with applicable statutory frameworks - Where premarket review authority exists, attention to nanomaterials is incorporated into standing procedures - Where statutory authority does not provide for premarket review, consultation is encouraged to address potential risk to human or animal health 7 7
FDA’s Regulatory Policy Approach (2) • Current frameworks for evaluating safety are sufficiently robust and flexible • Continue post-market monitoring • Industry remains responsible for ensuring that products meet all applicable requirements, incl. safety standards • Encourage early industry consultation • Collaborate, as appropriate, with domestic and international regulatory partners and stakeholders • Offer technical advice and guidance, as needed, to help industry meet its obligations Hamburg, 2012. Science 336:299-300. 8 8
Communicating FDA’s Current Thinking • 2007 FDA Nanotechnology Task Force report – Recommendations on regulatory science and policy • Agency-level Draft Guidance for Industry, issued June 2011 • Product-specific guidances for industry, as needed – Foods Draft Guidance, issued April 2012 – Cosmetics Draft Guidance, issued April 2012 • Policies and procedures for internal reviewers, as needed – CMC reviews of human drugs, 2010 – Evaluation of new animal drugs, 2011 9 9
General Considerations Related to Definitions/Descriptions • Terminology • Whether to exclude naturally occurring, incidental, or other categories of materials • Size as a criterion • How to address aggregates, agglomerates, and complex structures • Use of percent size distribution threshold • Focus on potential “novel” or “unique” properties • Whether and what other attributes are appropriate 10
FDA’s 2011 Draft Guidance for Industry (1) Considering whether a FDA-regulated product involves the application of nanotechnology Issued in June 2011, at the same time as: - USG Policy principles for regulation and oversight of nanotechnology http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm 11 11
FDA’s 2011 Draft Guidance for Industry (2) Two Points to Consider • Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or • Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer. 12 12
FDA’s 2011 Draft Guidance for Industry (3) • Applicable to all FDA-regulated products • Does not establish a regulatory definition; applies a broad screening tool for FDA purposes • Recognizes FDA’s interest beyond size alone; extending to properties • Provides broader context for product-specific guidances • Consistent with U.S. policy principles • Encourages industry to consult with FDA early in the product development process to address questions about safety, effectiveness, and/or regulatory status 13 13
Comparison of Descriptions European Commission FDA’s Points to Consider Health Canada’s Working Recommendation Definition - Whether an engineered a natural, incidental or material or end product has any manufactured substance manufactured material at least one dimension in the or product and any containing particles, in an nanoscale range component material, unbound state or as an (approximately 1 nm to 100 ingredient, device, or aggregate or as an nm); or structure -- if: agglomerate and where, for - Whether an engineered - It is at or within the 50 % or more of the particles material or end product nanoscale in at least one in the number size exhibits properties or external dimension, or has distribution, one or more phenomena, including internal or surface structure external dimensions is in the physical or chemical at the nanoscale, or; size range 1 nm-100 nm. In properties or biological - It is smaller or larger than specific cases and where effects, that are attributable the nanoscale in all warranted by concerns for to its dimension(s), even if dimensions and exhibits one the environment, health, these dimensions fall outside or more nanoscale safety or competitiveness the the nanoscale range, up to properties/phenomena number size distribution one micrometer threshold of 50 % may be replaced by a threshold between 1 and 50 % 14
FDA’s 2012 Draft Guidances for Industry • Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products • Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm 301093.htm 15 15
Cosmetics Draft Guidance - Describes current thinking on safety assessments of nanomaterials when used in cosmetic products - Manufacturers are responsible for assuring that cosmetics (incl. those containing nanomaterials) are safe and properly labeled - In general, processes currently in use for safety assessment are appropriate for cosmetics containing nanomaterials. But data needs and testing methods should be evaluated in light of nanomaterial properties - Early consultation is encouraged http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301093.h tm 16 16
Foods Draft Guidance - Significant changes to manufacturing processes may affect identity, safety, and/or regulatory status of food substances (and may warrant regulatory submission) - Intentional alterations in particle size distribution on the nanometer scale can sometimes be significant manufacturing changes - For nanotechnology and conventional products alike, FDA considers the characteristics of the product and safety of its intended use Early consultation is encouraged - http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301093. htm 17 17
Advancing Regulatory Science FDA’s Strategic Plan for Regulatory Science , August 2011 http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/Regulator yScience/UCM268225.pdf “ FDA will advance regulatory science to speed innovation, improve regulatory decision-making, and get safe and effective products to people in need” Science Priority Areas include to: – Ensure FDA readiness to evaluate innovative emerging technologies 18 18
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