FDAs Approach to Regulation of Nanotechnology Products Ritu - - PowerPoint PPT Presentation

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

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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– Policy Considerations – Agency-level draft guidance to industry – Relevant USG and international context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

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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

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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

Policy Considerations

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• 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

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U.S. Government Policy

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• 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

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FDA’s Regulatory Policy Approach (1)

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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

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FDA’s Regulatory Policy Approach (2)

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• 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.

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Communicating FDA’s Current Thinking

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• 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

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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

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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

FDA’s 2011 Draft Guidance for Industry (1)

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FDA’s 2011 Draft Guidance for Industry (2)

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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.

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FDA’s 2011 Draft Guidance for Industry (3)

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• 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

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Comparison of Descriptions

FDA’s 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

• ne micrometer

Health Canada’s Working Definition any manufactured substance

• r product and any

component material, ingredient, device, or structure -- if:

• It is at or within the

nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale, or;

• It is smaller or larger than

the nanoscale in all dimensions and exhibits one

• r more nanoscale

properties/phenomena European Commission Recommendation a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %

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FDA’s 2012 Draft Guidances for Industry

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• 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

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Cosmetics Draft Guidance

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• 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

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Foods Draft Guidance

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• 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

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Advancing Regulatory Science

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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

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FDA Nanotechnology Regulatory Science Research Project Categories

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• Physico-chemical characterization

– Methods and tools to detect and measure physical structure, chemical properties, and safety

• Nonclinical modeling of nanomaterials

– In vitro and in vivo assays and models to assess safety and/or efficacy

• Risk characterization information

– Hazard identification, exposure, and risk modeling

• Risk Assessment

– Potential generalized, class-based approaches

• Risk Communication

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm196697.h tm

FDA Nanotechnology Regulatory Science Research Plan

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm273325.htm

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Multi-level FDA Activities

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Interactions with domestic stakeholders

• USG partnerships - National Nanotechnology Initiative,

Emerging Technologies Inter-Agency Policy Coordination Committee

• Ongoing dialogue with USG regulatory agencies
• Public meetings; documents for public comment

Interactions at international level

• Ongoing dialogue with international regulatory counterparts
• FDA-level agency-to-agency collaboration
• USG-level regulatory cooperation and trade forums
• Participation in standards-setting activities
• ISO, OECD, ICCR

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Dialogue with International Regulatory Partners US-Canada Nanotechnology Work Plan, May 2012

http://www.whitehouse.gov/sites/default/files/omb/oira/irc/us- canada_rcc_joint_action_plan.pdf;

US-Mexico Nanotechnology Work Plan, February 2012

http://www.whitehouse.gov/sites/default/files/omb/oira/irc/united-states- mexico-high-level-regulatory-cooperation-council-work-plan.pdf;

US-EU Nanotechnology Dialogue

http://www.state.gov/p/eur/rls/or/178419.htm#nanotechnology

• Exchange views on relevant scientific developments
• Develop common approaches, to extent possible
• Identify points of common interest and dialogue

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Summary

• FDA will continue to regulate nanotechnology products under

applicable regulatory frameworks

• Current framework for safety assessments sufficiently robust

and flexible to consider nanomaterials

• Investments in an FDA-wide nanotechnology regulatory

science program to further enhance FDA’s scientific capabilities

• Draft guidances to industry – issued in 2011, 2012
• Encourage industry to consult with FDA early in product

development to address questions about safety, effectiveness, and/or regulatory status

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For information on FDA activities: FDA Nanotechnology Homepage: http://www.fda.gov/ScienceResearch/Spec ialTopics/Nanotechnology/default.htm FDA Office of Policy 301-796-4830 Ritu.Nalubola@fda.hhs.gov

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