SlideShare a Scribd company logo
1 of 36
Download to read offline
Conflicts of Interest in Approvals of
GRAS Additives: Out of Balance
Tom Neltner
Project Director, Food Additives Project
The Pew Charitable Trusts
11
Overview
Introduction to food work at the Pew Charitable Trusts
Summary of work by Pew’s Food Additives Project
Discussion of FDA’s Generally Recognized as Safe (GRAS)
Exemption
Review of conflicts of interest (COI) in GRAS decision making
Conclusions
2
Pew’s approach to food
Science-based policies
Pragmatic, effective solutions
Transparency
Engage all stakeholders
3
Food-related projects at Pew
Food Safety Project
FDA Food Safety
Modernization Act
Meat & poultry
investigation
Kids Safe and Healthful
Foods
Human Health and
Industrial Farming
4
Food Additives Project
Launched in 2010:
Comprehensive analysis of
regulatory program/science
Develop evidence-based policy
recommendations
Transparent process engages
industry, academic, government
and public interest stakeholders
Workshops and articles, primarily
in peer-reviewed journals
5
Cosponsored by Nature and Institute of Food Technologists (IFT)
Hazard assessment – April 2011
Exposure assessment – November 2011
Policy options – April 2012
Dose response for endocrine disruptors – April 2012
Potential conflicts of interest in GRAS
additive decisions – August 2013
Workshops held by Pew
6
Navigating the U.S. Food Additive Regulatory Program – 2011
Hazard Assessment Workshop Proceedings – 2011
Exposure assessment Workshop Proceedings – 2013
Looking Back to Look Forward: A Review of FDA’s Food
Additives Safety Assessment and Recommendations for
Modernizing its Program – June 12, 2013
Data Gaps in Toxicity Testing of Chemicals Allowed in Food in
the U.S. – In Press
Conflicts of Interest in Approvals of Additives to Food
Determined to be GRAS: Out of Balance – August 7, 2013
Capstone Report – Expected August 2013
Articles authored by Pew
7
Evaluation of food additive issues by American
Academy of Pediatrics (AAP)
“NanoRelease Food Additives” project at
International Life Sciences Institute (ILSI) Research
Foundation
“Endocrine Active Chemicals: Science to Practice”
workshop by National Institutes of Health and
European Commission
Review of regulation and safety assessments
outside the U.S. by Berna Magnuson and Cantox
International
“Chemical Testing in the 21st Century” workshop by
the Environmental Defense Fund
Related research supported by Pew
88
Basics
~ 10,000 chemicals allowed to
be added to food
~ 3,000 not reviewed by FDA
~ 1,000 unknown to FDA
Concerns about GRAS &
implications for FDA’s science
and reassessment of old
decisions
99
Generally Recognized as Safe (GRAS)
exemption
In 1958 Congress exempted use of GRAS additives from Food
Additive Petition requirement
FDA allows manufacturers to make GRAS safety
determinations without notifying the agency
Since 1997, FDA has encouraged voluntary notifications of
GRAS determinations. FDA review results in:
No questions letters
Insufficient basis letters
Cease to evaluate letters
Over the past 10 years, GRAS Notifications outnumber Food
Additive Petitions by more than 14 to 1 for direct additives
10
“One of FDA’s principal missions is to ensure the safety of the
nation’s food supply, but a growing number of substances that
companies have determined are GRAS may effectively be
excluded from federal oversight.”
“However, FDA may be constrained in detecting any such
future problems because it lacks information about an unknown
number of substances companies have determined to be
GRAS without informing the agency.”
“[W]ithout issuing guidance on how to prevent conflicts of
interest and information in companies’ GRAS notices regarding
expert panelists’ independence, FDA has less assurance of the
independence of the experts companies employ to support
their GRAS determinations.”
2010 GAO GRAS Report
11
Recommendation: Develop a
strategy to minimize the potential for
conflicts of interest in companies’
determinations.
Status: As of May 2012, FDA has
not decided what, if any, actions it
will take.
FDA comments:
Requested comments on
several GAO recommendations
on December 28, 2010
Reviewing comments received
Conflicts of interest:
GAO Recommendation #4
1212
Conflicts of Interest in Approvals of Additives to
Food Determined to be GRAS: Out of Balance
Journal of American Medical Association Internal Medicine
Available on-line on August 7, 2013
Authors
Tom Neltner, Heather Alger and Maricel Maffini of Pew
Lisa Bero of University of California San Francisco
Sheldon Krimsky of Tufts University
James O’Reilly of University of Cincinnati
Evaluates 451 GRAS Notices voluntarily submitted to FDA
from 1997 to 2012
Analysis based on framework in Institute of Medicine’s (IOM)
2009 Report on “Conflicts of Interest in Medical Research,
Education and Practice”
1313
IOM framework to analyze conflicts of interest
COI = “Set of circumstances that creates a risk that the
professional judgment or actions regarding a primary interest
will be unduly influenced by a secondary interest.”
Primary interest = Ensuring use is GRAS consistent with law
Secondary interest = Potential for financial gain to additive
manufacturer
Does not evaluate specific decisions
1414
Assessing severity of COI: 2 part analysis
Likelihood that a decision could be unduly influenced by COI
Value of secondary interest
Scope of relationship
Extent of discretion
Seriousness of possible harm if the decision was influenced
Value of primary interest
Scope of the consequences
Extent of accountability
15
Likelihood that evaluation would be unduly influenced
by the financial interests of an additive manufacturer*
Greaterlikelihoodof
undueinfluence
Category of decision-maker
1. Employee of additive manufacturer
2. Employee of consulting firm selected by
additive manufacturer
3. Expert panel selected by firm or
manufacturer
4. Standing expert panel selected by third
party
5. Employee of the FDA
* Using Institute of Medicine 2009 framework
16
Seriousness of possible harm IF evaluation is unduly
influenced by the financial interests of an additive
manufacturer*
Greaterseriousness
ofharm
Type of FDA review
1. No review
2. FDA reviews but does not make notice
publicly available
3. FDA reviews and makes notice publicly
available
* Using Institute of Medicine 2009 framework
1717
Results
Types of individuals making
determinations
Frequency of experts serving on
panels
FDA actions when not notified
1818
Type of individuals making GRAS evaluations
submitted to FDA
Decision-maker Number of notices
Employee of additive manufacturer 101
(22.4%)
Employee of consulting firm selected by
additive manufacturer
60
(13.3%)
Expert panel selected by firm or manufacturer 290
(64.3%)
Standing expert panel selected by third party 0
(0%)
1919
10 individuals served most frequently on the expert
panels making GRAS evaluations
Individual Number of expert panels
served on
#1 128 (44.1%)
#2 41 (14.1%)
#3 40 (13.8%)
#4 38 (13.1%)
#5 35 (12.1%)
#6 34 (11.8%)
#7 34 (11.8%)
#8 28 (9.7%)
#9 28 (9.7%)
#10 27 (9.3%)
2020
FDA actions when not notified
Considered 1997 to 2012
1 action when FDA sought to obtain GRAS safety
determination for which it had not been notified
Caffeine in alcohol beverages
2121
Limitations
Did not evaluate determinations:
Not voluntarily sent to FDA
Made by Flavor and Extract Manufacturers Association’s (FEMA)
Expert Panel
Only considered employment of individuals
Does not prove COI actually compromised GRAS
determination process
Individual integrity
Organizational policies
No conflict between short-term gain and long-term brand
Due to insufficient information
2222
Conclusions
Financial conflicts of interest were ubiquitous in GRAS
determinations by additive manufacturers
Raises concern about:
Integrity of the process
Whether it ensures safety of the food supply
Particular concern when manufacturer does not notify FDA
FDA should:
Require it be notified of all GRAS determinations and of financial
COIs
Make public all GRAS determinations including those by FEMA
for flavors
Discussion Draft of Pew’s “Guidance
for Industry Selection of Experts
Conducting GRAS Evaluations”
Tom Neltner
Project Director, Food Additives Project
The Pew Charitable Trusts
11
Overview
Purpose
But first . . .
Four questions
Exemptions
Comparison to similar
programs
22
Purpose of draft guidance
Address shortcomings raised by Pew and U.S. Government
Accountability Office (GAO)
Provide FDA with specific language to implement
recommendation from GAO in 2010 regarding Conflicts of
Interest (COI).
GAO said FDA should develop a strategy to minimize the
potential for conflicts of interest in companies’ determinations.
On 12/28/10, FDA requested comments on COI and other
issues
10 of 17 comments received addressed COI
All 10 supported FDA issuing guidance
2 said FDA should only act if it felt guidance necessary
One suggested FDA consider clinical investigator standards at 21
CFR Part 54
33
But first . . .
Unlike regulations, guidance documents are not binding
Draft guidance would not apply to the following situations
because they are not eligible for GRAS exemption:
Color additives, pesticides or animal drugs
Uses inconsistent with FDA’s food additive regulations for
specific additive use
Significantly different conditions of
use from those allowed in FDA’s
GRAS affirmation regulations
44
Exemptions from proposed draft guidance
When decision does not qualify for GRAS exemption
When new use is within the same general food category and is
performing the same physical or technical functional effect as
an existing use (43 food categories at 21 CFR 170.3)
If estimated daily intake is less than 1% of acceptable daily
intake
When change does not involve significant changes in the raw
materials or increase in portion of particles less than 100
nanometers in size.
55
Key resources
FDA’s 2008 guidance on determining COI and eligibility for
participation in its advisory committees
Institute of Medicine’s 2009 “Conflict of Interest in Medical
Research, Education and Practice” Report
Flavor and Extract Manufacturers Association’s Expert Panel
COI policy
European Food Safety Authority’s (EFSA) policy on
independence and scientific decision-making processes
regarding declarations of interests
World Health Organization (WHO) policy on conflict of interest
for expert committee on food additives
66
Four questions to industry should answer
before selecting an expert:
Does the expert have the necessary
expertise?
Do the experts have sufficient
diversity of experience and
knowledge to objectively represent
the consensus of the scientific
community?
Is the expert disqualified because of
serious financial conflicts of interest?
Are there non-financial conflicts of
interest that need to be considered?
77
Q1: Does the expert have the necessary expertise?
Experts need to know FDA’s guidance in their field
Substance characterization needed for:
Substance not previously used in food
Significant manufacturing process changes
Hazard assessment
Typically yes, especially when acceptable
daily intake not generally recognized
Exposure assessment
Typically yes, especially when estimated
daily intake not generally recognized
88
Q2: Do the experts have sufficient diversity of
experience and knowledge to objectively represent
the consensus of the scientific community?
Sufficient understanding of the broad
scientific literature
Aware of opinions or published
articles, especially those with
differing views.
Not author of pivotal data. (The
person could prepare dossier but not
make decision.)
99
Q3: Is the expert disqualified because of serious
financial conflicts of interest?
Yes, if person would be disqualified because of a financial COI
from serving on an FDA advisory committee
Steps (see Appendix 2 for details):
Identify financial connections
Determine if decision would “direct and predictable effect” on
those financial connections
Determine if there is a “disqualifying financial interest”
Waiver option not available
1010
Q4: Are there non-financial conflicts of interest that
need to be considered?
Knowledge of the identity of the firm (FEMA)
Contact with firm during deliberations (FEMA)
Expert testimony indicating bias to interests (WHO-JECFA)
Other than a food safety organization:
Membership on managing body of a public or private entity with
interest in decision (EFSA)
Membership on a scientific advisory body with a right to influence
that body’s decisions where body has interest in decision (EFSA)
Providing advice even for free to trade associations with an
interest in the decision (EFSA)
1111
Next steps
We plan to submit draft
guidance on Monday,
August 18
If you send us your
written comments by
Wednesday, August 14,
we will include them in
our submission to FDA
We will share with FDA
copy of webinar and any
written comments
received
12
For more information on
Pew’s Food Additive Project
Contact:
Tom Neltner, Project Director
The Pew Charitable Trusts
202.540.6475
tneltner@pewtrusts.org
www.pewtrusts.org

More Related Content

What's hot

5 myers hiv self-testing in new york city
5 myers hiv self-testing in new york city5 myers hiv self-testing in new york city
5 myers hiv self-testing in new york citySlidesShare_Foxtrot
 
6 bronson state of virginia's hiv self-testing initiatives
6 bronson state of virginia's hiv self-testing initiatives6 bronson state of virginia's hiv self-testing initiatives
6 bronson state of virginia's hiv self-testing initiativesSlidesShare_Foxtrot
 
The Art and Science of Productive FDA Meetings
The Art and Science of Productive FDA MeetingsThe Art and Science of Productive FDA Meetings
The Art and Science of Productive FDA MeetingsPAREXEL International
 
Data Integrity Validation Keynote Address Boston August 2016
Data Integrity Validation Keynote Address Boston August 2016Data Integrity Validation Keynote Address Boston August 2016
Data Integrity Validation Keynote Address Boston August 2016Ajaz Hussain
 
One size does not fit all unique study management challenges for diagnostic ...
One size does not fit all  unique study management challenges for diagnostic ...One size does not fit all  unique study management challenges for diagnostic ...
One size does not fit all unique study management challenges for diagnostic ...Lyssa Friedman
 
Role responsibilities of_a_clinical_research_coord
Role responsibilities of_a_clinical_research_coordRole responsibilities of_a_clinical_research_coord
Role responsibilities of_a_clinical_research_coordsushant deshmukh
 
Rx15 tpp tues_1230_allen-emptage
Rx15 tpp tues_1230_allen-emptageRx15 tpp tues_1230_allen-emptage
Rx15 tpp tues_1230_allen-emptageOPUNITE
 
PPT by TAREK GAAD
PPT by TAREK GAADPPT by TAREK GAAD
PPT by TAREK GAADTarek Gaad
 
Rx16 tpp wed_111_panel_paduda_pew
Rx16 tpp wed_111_panel_paduda_pewRx16 tpp wed_111_panel_paduda_pew
Rx16 tpp wed_111_panel_paduda_pewOPUNITE
 
Global Promotional Review
Global Promotional Review Global Promotional Review
Global Promotional Review Alan Bergstrom
 
Applied aatod presentation highlights
Applied aatod presentation highlightsApplied aatod presentation highlights
Applied aatod presentation highlightsRichard Littlewood
 
GPhA Labeling Rule
GPhA Labeling RuleGPhA Labeling Rule
GPhA Labeling RuleDavid Hood
 
Emerging diagnostic technologies proving the clinical application through g...
Emerging diagnostic technologies   proving the clinical application through g...Emerging diagnostic technologies   proving the clinical application through g...
Emerging diagnostic technologies proving the clinical application through g...Lyssa Friedman
 
Exas july 2017 corporate presentation final
Exas july 2017 corporate presentation finalExas july 2017 corporate presentation final
Exas july 2017 corporate presentation finalExact Sciences
 
Who expert committee recommendations for pharmaceutical products
Who expert committee recommendations for pharmaceutical productsWho expert committee recommendations for pharmaceutical products
Who expert committee recommendations for pharmaceutical productsswati2084
 
The Secret to Successful Early Phase Study Expansions in Canada
The Secret to Successful Early Phase Study Expansions in CanadaThe Secret to Successful Early Phase Study Expansions in Canada
The Secret to Successful Early Phase Study Expansions in CanadaRoberto Lara
 
Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...
Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...
Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...Burdock Group Consultants
 

What's hot (20)

Best Practices for Promotional Content Review
Best Practices for Promotional Content ReviewBest Practices for Promotional Content Review
Best Practices for Promotional Content Review
 
5 myers hiv self-testing in new york city
5 myers hiv self-testing in new york city5 myers hiv self-testing in new york city
5 myers hiv self-testing in new york city
 
6 bronson state of virginia's hiv self-testing initiatives
6 bronson state of virginia's hiv self-testing initiatives6 bronson state of virginia's hiv self-testing initiatives
6 bronson state of virginia's hiv self-testing initiatives
 
The Art and Science of Productive FDA Meetings
The Art and Science of Productive FDA MeetingsThe Art and Science of Productive FDA Meetings
The Art and Science of Productive FDA Meetings
 
Data Integrity Validation Keynote Address Boston August 2016
Data Integrity Validation Keynote Address Boston August 2016Data Integrity Validation Keynote Address Boston August 2016
Data Integrity Validation Keynote Address Boston August 2016
 
One size does not fit all unique study management challenges for diagnostic ...
One size does not fit all  unique study management challenges for diagnostic ...One size does not fit all  unique study management challenges for diagnostic ...
One size does not fit all unique study management challenges for diagnostic ...
 
Role responsibilities of_a_clinical_research_coord
Role responsibilities of_a_clinical_research_coordRole responsibilities of_a_clinical_research_coord
Role responsibilities of_a_clinical_research_coord
 
Rx15 tpp tues_1230_allen-emptage
Rx15 tpp tues_1230_allen-emptageRx15 tpp tues_1230_allen-emptage
Rx15 tpp tues_1230_allen-emptage
 
PPT by TAREK GAAD
PPT by TAREK GAADPPT by TAREK GAAD
PPT by TAREK GAAD
 
AWARE - Providin High Value
AWARE - Providin High ValueAWARE - Providin High Value
AWARE - Providin High Value
 
Rx16 tpp wed_111_panel_paduda_pew
Rx16 tpp wed_111_panel_paduda_pewRx16 tpp wed_111_panel_paduda_pew
Rx16 tpp wed_111_panel_paduda_pew
 
Working with the FDA
Working with the FDAWorking with the FDA
Working with the FDA
 
Global Promotional Review
Global Promotional Review Global Promotional Review
Global Promotional Review
 
Applied aatod presentation highlights
Applied aatod presentation highlightsApplied aatod presentation highlights
Applied aatod presentation highlights
 
GPhA Labeling Rule
GPhA Labeling RuleGPhA Labeling Rule
GPhA Labeling Rule
 
Emerging diagnostic technologies proving the clinical application through g...
Emerging diagnostic technologies   proving the clinical application through g...Emerging diagnostic technologies   proving the clinical application through g...
Emerging diagnostic technologies proving the clinical application through g...
 
Exas july 2017 corporate presentation final
Exas july 2017 corporate presentation finalExas july 2017 corporate presentation final
Exas july 2017 corporate presentation final
 
Who expert committee recommendations for pharmaceutical products
Who expert committee recommendations for pharmaceutical productsWho expert committee recommendations for pharmaceutical products
Who expert committee recommendations for pharmaceutical products
 
The Secret to Successful Early Phase Study Expansions in Canada
The Secret to Successful Early Phase Study Expansions in CanadaThe Secret to Successful Early Phase Study Expansions in Canada
The Secret to Successful Early Phase Study Expansions in Canada
 
Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...
Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...
Harmonization of Approaches for Food Ingredients and Constituents: Is It Poss...
 

Viewers also liked

Getting Started with GFSI (For Manufacturers)
Getting Started with GFSI (For Manufacturers)Getting Started with GFSI (For Manufacturers)
Getting Started with GFSI (For Manufacturers)TraceGains
 
Plan de negocios
Plan de negociosPlan de negocios
Plan de negociosJay Park
 
Uso de wi di para Android(castellano)
Uso de wi di para Android(castellano)Uso de wi di para Android(castellano)
Uso de wi di para Android(castellano)videos
 
Top 8 office administration assistant resume samples
Top 8 office administration assistant resume samplesTop 8 office administration assistant resume samples
Top 8 office administration assistant resume samplesElliottYamin012
 
Front cover and contents page pictures
Front cover and contents page picturesFront cover and contents page pictures
Front cover and contents page picturesasmediae15
 
140625 vi pad webinar_collaboration tools
140625 vi pad webinar_collaboration tools140625 vi pad webinar_collaboration tools
140625 vi pad webinar_collaboration toolsMFG Innovationsagentur
 
Connected Cars: Assessing the Impact
Connected Cars: Assessing the Impact Connected Cars: Assessing the Impact
Connected Cars: Assessing the Impact Tavleen Mehendiratta
 
Rio Global inc presentation
Rio Global inc presentationRio Global inc presentation
Rio Global inc presentationRio Global
 
Introducing docker
Introducing dockerIntroducing docker
Introducing dockerDharmit Shah
 
104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授
104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授
104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授文化大學
 

Viewers also liked (20)

ASEAN Harmonisation TM & HS Registration 2012
ASEAN Harmonisation TM & HS Registration 2012ASEAN Harmonisation TM & HS Registration 2012
ASEAN Harmonisation TM & HS Registration 2012
 
Getting Started with GFSI (For Manufacturers)
Getting Started with GFSI (For Manufacturers)Getting Started with GFSI (For Manufacturers)
Getting Started with GFSI (For Manufacturers)
 
Control of dietary supplements in malaysia
Control of dietary supplements in malaysiaControl of dietary supplements in malaysia
Control of dietary supplements in malaysia
 
Health Supplements Registration in Malaysia
Health Supplements Registration in MalaysiaHealth Supplements Registration in Malaysia
Health Supplements Registration in Malaysia
 
My evaluation!
My evaluation!My evaluation!
My evaluation!
 
Dispositivos moviles 1
Dispositivos moviles 1Dispositivos moviles 1
Dispositivos moviles 1
 
Plan de negocios
Plan de negociosPlan de negocios
Plan de negocios
 
Uso de wi di para Android(castellano)
Uso de wi di para Android(castellano)Uso de wi di para Android(castellano)
Uso de wi di para Android(castellano)
 
Top 8 office administration assistant resume samples
Top 8 office administration assistant resume samplesTop 8 office administration assistant resume samples
Top 8 office administration assistant resume samples
 
Front cover and contents page pictures
Front cover and contents page picturesFront cover and contents page pictures
Front cover and contents page pictures
 
140625 vi pad webinar_collaboration tools
140625 vi pad webinar_collaboration tools140625 vi pad webinar_collaboration tools
140625 vi pad webinar_collaboration tools
 
Connected Cars: Assessing the Impact
Connected Cars: Assessing the Impact Connected Cars: Assessing the Impact
Connected Cars: Assessing the Impact
 
Lenny resume
Lenny  resumeLenny  resume
Lenny resume
 
Literacy finalhu
Literacy finalhuLiteracy finalhu
Literacy finalhu
 
Rio Global inc presentation
Rio Global inc presentationRio Global inc presentation
Rio Global inc presentation
 
Introducing docker
Introducing dockerIntroducing docker
Introducing docker
 
104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授
104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授
104.09.09 1-德國農莊-顧客行為分析-創造顧客價值與創造消費者需求-詹翔霖教授
 
Portfolio
PortfolioPortfolio
Portfolio
 
дитина за комп
дитина за компдитина за комп
дитина за комп
 
World Cup Unit Student 6.2
World Cup Unit Student 6.2World Cup Unit Student 6.2
World Cup Unit Student 6.2
 

Similar to Conflicts of Interest in Approvals of GRAS Additives_2013

Chapter 19Clinical Trials Clinical TrialsThe history
Chapter 19Clinical Trials Clinical TrialsThe history Chapter 19Clinical Trials Clinical TrialsThe history
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
 
IND (Investigational New Drug) industrial perspective
IND (Investigational New Drug) industrial perspectiveIND (Investigational New Drug) industrial perspective
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
 
Fda Pros And Cons
Fda Pros And ConsFda Pros And Cons
Fda Pros And ConsNicole King
 
Marketing Approval For Medicinal Products Essay
Marketing Approval For Medicinal Products EssayMarketing Approval For Medicinal Products Essay
Marketing Approval For Medicinal Products EssayKatreka Howard
 
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...ClinosolIndia
 
Process Of A Clinical Trial
Process Of A Clinical TrialProcess Of A Clinical Trial
Process Of A Clinical TrialHeather Dionne
 
Group4padgett&becoatm6a1
Group4padgett&becoatm6a1Group4padgett&becoatm6a1
Group4padgett&becoatm6a1Stephen Padgett
 
Group4 padgett&becoatm6a1
Group4 padgett&becoatm6a1Group4 padgett&becoatm6a1
Group4 padgett&becoatm6a1Henry Becoat
 
Determinants of New Molecular Entity Approval by United States Food & Drug Ad...
Determinants of New Molecular Entity Approval by United States Food & Drug Ad...Determinants of New Molecular Entity Approval by United States Food & Drug Ad...
Determinants of New Molecular Entity Approval by United States Food & Drug Ad...inventionjournals
 
industry and FDA liaisons
industry and FDA liaisonsindustry and FDA liaisons
industry and FDA liaisonsfouza ameer
 
Indusrty and Fda liasions
Indusrty and Fda liasionsIndusrty and Fda liasions
Indusrty and Fda liasionsROHIT
 
Idarucizumab Research Paper
Idarucizumab Research PaperIdarucizumab Research Paper
Idarucizumab Research PaperMichelle Davis
 
RegulatoryIssues In Drug management cycle
RegulatoryIssues In Drug management cycleRegulatoryIssues In Drug management cycle
RegulatoryIssues In Drug management cycleHarunMohamed7
 
FDA Enforcement: What Every Clinical Director Should Know
FDA Enforcement:  What Every Clinical Director Should KnowFDA Enforcement:  What Every Clinical Director Should Know
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
 
Application Via The 505 ( B ) 2 Mechanism
Application Via The 505 ( B ) 2 MechanismApplication Via The 505 ( B ) 2 Mechanism
Application Via The 505 ( B ) 2 MechanismJamie Boyd
 
Investigation New Drug Application
Investigation New Drug ApplicationInvestigation New Drug Application
Investigation New Drug ApplicationJessica Huston
 

Similar to Conflicts of Interest in Approvals of GRAS Additives_2013 (20)

Chapter 19Clinical Trials Clinical TrialsThe history
Chapter 19Clinical Trials Clinical TrialsThe history Chapter 19Clinical Trials Clinical TrialsThe history
Chapter 19Clinical Trials Clinical TrialsThe history
 
Sept. CTA
Sept. CTASept. CTA
Sept. CTA
 
IND (Investigational New Drug) industrial perspective
IND (Investigational New Drug) industrial perspectiveIND (Investigational New Drug) industrial perspective
IND (Investigational New Drug) industrial perspective
 
Inside the FDA
Inside the FDAInside the FDA
Inside the FDA
 
Fda Pros And Cons
Fda Pros And ConsFda Pros And Cons
Fda Pros And Cons
 
Marketing Approval For Medicinal Products Essay
Marketing Approval For Medicinal Products EssayMarketing Approval For Medicinal Products Essay
Marketing Approval For Medicinal Products Essay
 
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
 
Process Of A Clinical Trial
Process Of A Clinical TrialProcess Of A Clinical Trial
Process Of A Clinical Trial
 
Group4padgett&becoatm6a1
Group4padgett&becoatm6a1Group4padgett&becoatm6a1
Group4padgett&becoatm6a1
 
Group4 padgett&becoatm6a1
Group4 padgett&becoatm6a1Group4 padgett&becoatm6a1
Group4 padgett&becoatm6a1
 
Determinants of New Molecular Entity Approval by United States Food & Drug Ad...
Determinants of New Molecular Entity Approval by United States Food & Drug Ad...Determinants of New Molecular Entity Approval by United States Food & Drug Ad...
Determinants of New Molecular Entity Approval by United States Food & Drug Ad...
 
industry and FDA liaisons
industry and FDA liaisonsindustry and FDA liaisons
industry and FDA liaisons
 
FDA liaisions
FDA liaisionsFDA liaisions
FDA liaisions
 
Indusrty and Fda liasions
Indusrty and Fda liasionsIndusrty and Fda liasions
Indusrty and Fda liasions
 
Review
ReviewReview
Review
 
Idarucizumab Research Paper
Idarucizumab Research PaperIdarucizumab Research Paper
Idarucizumab Research Paper
 
RegulatoryIssues In Drug management cycle
RegulatoryIssues In Drug management cycleRegulatoryIssues In Drug management cycle
RegulatoryIssues In Drug management cycle
 
FDA Enforcement: What Every Clinical Director Should Know
FDA Enforcement:  What Every Clinical Director Should KnowFDA Enforcement:  What Every Clinical Director Should Know
FDA Enforcement: What Every Clinical Director Should Know
 
Application Via The 505 ( B ) 2 Mechanism
Application Via The 505 ( B ) 2 MechanismApplication Via The 505 ( B ) 2 Mechanism
Application Via The 505 ( B ) 2 Mechanism
 
Investigation New Drug Application
Investigation New Drug ApplicationInvestigation New Drug Application
Investigation New Drug Application
 

More from Asian Food Regulation Information Service

Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...Asian Food Regulation Information Service
 

More from Asian Food Regulation Information Service (20)

Hong kong Dietary Guideline for Adults
Hong kong Dietary Guideline for AdultsHong kong Dietary Guideline for Adults
Hong kong Dietary Guideline for Adults
 
Wine Tourism
Wine TourismWine Tourism
Wine Tourism
 
Food Tourism
Food TourismFood Tourism
Food Tourism
 
Trends and Issues in Tourism and Hospitality
Trends and Issues in Tourism and HospitalityTrends and Issues in Tourism and Hospitality
Trends and Issues in Tourism and Hospitality
 
Vertical Farming inforgraphic
Vertical Farming inforgraphicVertical Farming inforgraphic
Vertical Farming inforgraphic
 
Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...
 
Food Allergens
Food AllergensFood Allergens
Food Allergens
 
Food Labelling Regulations and Challenges in ASEAN
Food Labelling Regulations and Challenges in ASEANFood Labelling Regulations and Challenges in ASEAN
Food Labelling Regulations and Challenges in ASEAN
 
Developing a Functional Food Product - Part 2
Developing a Functional Food Product - Part 2Developing a Functional Food Product - Part 2
Developing a Functional Food Product - Part 2
 
Developing a Functional Food Product - Part 1
Developing a Functional Food Product - Part 1Developing a Functional Food Product - Part 1
Developing a Functional Food Product - Part 1
 
Food Safety Audit and Assessment
Food Safety Audit and AssessmentFood Safety Audit and Assessment
Food Safety Audit and Assessment
 
Meeting the Food Traceability Challenge
Meeting the Food Traceability ChallengeMeeting the Food Traceability Challenge
Meeting the Food Traceability Challenge
 
Cold Chain Management
Cold Chain ManagementCold Chain Management
Cold Chain Management
 
Strengthening Regulation of Recycling of Waste Cooking Oils
Strengthening Regulation of Recycling of Waste Cooking OilsStrengthening Regulation of Recycling of Waste Cooking Oils
Strengthening Regulation of Recycling of Waste Cooking Oils
 
Revision of Drinking Water Quality Standards in Japan
Revision of Drinking Water Quality Standards in JapanRevision of Drinking Water Quality Standards in Japan
Revision of Drinking Water Quality Standards in Japan
 
Food Regulations in Indonesia
Food Regulations in IndonesiaFood Regulations in Indonesia
Food Regulations in Indonesia
 
Regulatory Perspectives on GM Food in Indonesia
Regulatory Perspectives on GM Food in IndonesiaRegulatory Perspectives on GM Food in Indonesia
Regulatory Perspectives on GM Food in Indonesia
 
Veterinary Drug Control - Pakistan
Veterinary Drug Control - PakistanVeterinary Drug Control - Pakistan
Veterinary Drug Control - Pakistan
 
Animal Quarantine and Certification Services
Animal Quarantine and Certification ServicesAnimal Quarantine and Certification Services
Animal Quarantine and Certification Services
 
Improving the Effectiveness of Online Advertising
Improving the Effectiveness of Online AdvertisingImproving the Effectiveness of Online Advertising
Improving the Effectiveness of Online Advertising
 

Recently uploaded

Emil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptx
Emil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptxEmil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptx
Emil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptxNeo4j
 
AI Workshops at Computers In Libraries 2024
AI Workshops at Computers In Libraries 2024AI Workshops at Computers In Libraries 2024
AI Workshops at Computers In Libraries 2024Brian Pichman
 
Introduction - IPLOOK NETWORKS CO., LTD.
Introduction - IPLOOK NETWORKS CO., LTD.Introduction - IPLOOK NETWORKS CO., LTD.
Introduction - IPLOOK NETWORKS CO., LTD.IPLOOK Networks
 
2024.03.12 Cost drivers of cultivated meat production.pdf
2024.03.12 Cost drivers of cultivated meat production.pdf2024.03.12 Cost drivers of cultivated meat production.pdf
2024.03.12 Cost drivers of cultivated meat production.pdfThe Good Food Institute
 
SIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENT
SIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENTSIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENT
SIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENTxtailishbaloch
 
Planetek Italia Srl - Corporate Profile Brochure
Planetek Italia Srl - Corporate Profile BrochurePlanetek Italia Srl - Corporate Profile Brochure
Planetek Italia Srl - Corporate Profile BrochurePlanetek Italia Srl
 
UiPath Studio Web workshop Series - Day 3
UiPath Studio Web workshop Series - Day 3UiPath Studio Web workshop Series - Day 3
UiPath Studio Web workshop Series - Day 3DianaGray10
 
UiPath Studio Web workshop series - Day 1
UiPath Studio Web workshop series  - Day 1UiPath Studio Web workshop series  - Day 1
UiPath Studio Web workshop series - Day 1DianaGray10
 
20140402 - Smart house demo kit
20140402 - Smart house demo kit20140402 - Smart house demo kit
20140402 - Smart house demo kitJamie (Taka) Wang
 
LF Energy Webinar - Unveiling OpenEEMeter 4.0
LF Energy Webinar - Unveiling OpenEEMeter 4.0LF Energy Webinar - Unveiling OpenEEMeter 4.0
LF Energy Webinar - Unveiling OpenEEMeter 4.0DanBrown980551
 
The Importance of Indoor Air Quality (English)
The Importance of Indoor Air Quality (English)The Importance of Indoor Air Quality (English)
The Importance of Indoor Air Quality (English)IES VE
 
Patch notes explaining DISARM Version 1.4 update
Patch notes explaining DISARM Version 1.4 updatePatch notes explaining DISARM Version 1.4 update
Patch notes explaining DISARM Version 1.4 updateadam112203
 
Explore the UiPath Community and ways you can benefit on your journey to auto...
Explore the UiPath Community and ways you can benefit on your journey to auto...Explore the UiPath Community and ways you can benefit on your journey to auto...
Explore the UiPath Community and ways you can benefit on your journey to auto...DianaGray10
 
Scenario Library et REX Discover industry- and role- based scenarios
Scenario Library et REX Discover industry- and role- based scenariosScenario Library et REX Discover industry- and role- based scenarios
Scenario Library et REX Discover industry- and role- based scenariosErol GIRAUDY
 
Trailblazer Community - Flows Workshop (Session 2)
Trailblazer Community - Flows Workshop (Session 2)Trailblazer Community - Flows Workshop (Session 2)
Trailblazer Community - Flows Workshop (Session 2)Muhammad Tiham Siddiqui
 
Graphene Quantum Dots-Based Composites for Biomedical Applications
Graphene Quantum Dots-Based Composites for  Biomedical ApplicationsGraphene Quantum Dots-Based Composites for  Biomedical Applications
Graphene Quantum Dots-Based Composites for Biomedical Applicationsnooralam814309
 
3 Pitfalls Everyone Should Avoid with Cloud Data
3 Pitfalls Everyone Should Avoid with Cloud Data3 Pitfalls Everyone Should Avoid with Cloud Data
3 Pitfalls Everyone Should Avoid with Cloud DataEric D. Schabell
 
How to release an Open Source Dataweave Library
How to release an Open Source Dataweave LibraryHow to release an Open Source Dataweave Library
How to release an Open Source Dataweave Libraryshyamraj55
 
UiPath Studio Web workshop series - Day 4
UiPath Studio Web workshop series - Day 4UiPath Studio Web workshop series - Day 4
UiPath Studio Web workshop series - Day 4DianaGray10
 
Outage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedIn
Outage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedInOutage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedIn
Outage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedInThousandEyes
 

Recently uploaded (20)

Emil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptx
Emil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptxEmil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptx
Emil Eifrem at GraphSummit Copenhagen 2024 - The Art of the Possible.pptx
 
AI Workshops at Computers In Libraries 2024
AI Workshops at Computers In Libraries 2024AI Workshops at Computers In Libraries 2024
AI Workshops at Computers In Libraries 2024
 
Introduction - IPLOOK NETWORKS CO., LTD.
Introduction - IPLOOK NETWORKS CO., LTD.Introduction - IPLOOK NETWORKS CO., LTD.
Introduction - IPLOOK NETWORKS CO., LTD.
 
2024.03.12 Cost drivers of cultivated meat production.pdf
2024.03.12 Cost drivers of cultivated meat production.pdf2024.03.12 Cost drivers of cultivated meat production.pdf
2024.03.12 Cost drivers of cultivated meat production.pdf
 
SIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENT
SIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENTSIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENT
SIM INFORMATION SYSTEM: REVOLUTIONIZING DATA MANAGEMENT
 
Planetek Italia Srl - Corporate Profile Brochure
Planetek Italia Srl - Corporate Profile BrochurePlanetek Italia Srl - Corporate Profile Brochure
Planetek Italia Srl - Corporate Profile Brochure
 
UiPath Studio Web workshop Series - Day 3
UiPath Studio Web workshop Series - Day 3UiPath Studio Web workshop Series - Day 3
UiPath Studio Web workshop Series - Day 3
 
UiPath Studio Web workshop series - Day 1
UiPath Studio Web workshop series  - Day 1UiPath Studio Web workshop series  - Day 1
UiPath Studio Web workshop series - Day 1
 
20140402 - Smart house demo kit
20140402 - Smart house demo kit20140402 - Smart house demo kit
20140402 - Smart house demo kit
 
LF Energy Webinar - Unveiling OpenEEMeter 4.0
LF Energy Webinar - Unveiling OpenEEMeter 4.0LF Energy Webinar - Unveiling OpenEEMeter 4.0
LF Energy Webinar - Unveiling OpenEEMeter 4.0
 
The Importance of Indoor Air Quality (English)
The Importance of Indoor Air Quality (English)The Importance of Indoor Air Quality (English)
The Importance of Indoor Air Quality (English)
 
Patch notes explaining DISARM Version 1.4 update
Patch notes explaining DISARM Version 1.4 updatePatch notes explaining DISARM Version 1.4 update
Patch notes explaining DISARM Version 1.4 update
 
Explore the UiPath Community and ways you can benefit on your journey to auto...
Explore the UiPath Community and ways you can benefit on your journey to auto...Explore the UiPath Community and ways you can benefit on your journey to auto...
Explore the UiPath Community and ways you can benefit on your journey to auto...
 
Scenario Library et REX Discover industry- and role- based scenarios
Scenario Library et REX Discover industry- and role- based scenariosScenario Library et REX Discover industry- and role- based scenarios
Scenario Library et REX Discover industry- and role- based scenarios
 
Trailblazer Community - Flows Workshop (Session 2)
Trailblazer Community - Flows Workshop (Session 2)Trailblazer Community - Flows Workshop (Session 2)
Trailblazer Community - Flows Workshop (Session 2)
 
Graphene Quantum Dots-Based Composites for Biomedical Applications
Graphene Quantum Dots-Based Composites for  Biomedical ApplicationsGraphene Quantum Dots-Based Composites for  Biomedical Applications
Graphene Quantum Dots-Based Composites for Biomedical Applications
 
3 Pitfalls Everyone Should Avoid with Cloud Data
3 Pitfalls Everyone Should Avoid with Cloud Data3 Pitfalls Everyone Should Avoid with Cloud Data
3 Pitfalls Everyone Should Avoid with Cloud Data
 
How to release an Open Source Dataweave Library
How to release an Open Source Dataweave LibraryHow to release an Open Source Dataweave Library
How to release an Open Source Dataweave Library
 
UiPath Studio Web workshop series - Day 4
UiPath Studio Web workshop series - Day 4UiPath Studio Web workshop series - Day 4
UiPath Studio Web workshop series - Day 4
 
Outage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedIn
Outage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedInOutage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedIn
Outage Analysis: March 5th/6th 2024 Meta, Comcast, and LinkedIn
 

Conflicts of Interest in Approvals of GRAS Additives_2013

  • 1. Conflicts of Interest in Approvals of GRAS Additives: Out of Balance Tom Neltner Project Director, Food Additives Project The Pew Charitable Trusts
  • 2. 11 Overview Introduction to food work at the Pew Charitable Trusts Summary of work by Pew’s Food Additives Project Discussion of FDA’s Generally Recognized as Safe (GRAS) Exemption Review of conflicts of interest (COI) in GRAS decision making Conclusions
  • 3. 2 Pew’s approach to food Science-based policies Pragmatic, effective solutions Transparency Engage all stakeholders
  • 4. 3 Food-related projects at Pew Food Safety Project FDA Food Safety Modernization Act Meat & poultry investigation Kids Safe and Healthful Foods Human Health and Industrial Farming
  • 5. 4 Food Additives Project Launched in 2010: Comprehensive analysis of regulatory program/science Develop evidence-based policy recommendations Transparent process engages industry, academic, government and public interest stakeholders Workshops and articles, primarily in peer-reviewed journals
  • 6. 5 Cosponsored by Nature and Institute of Food Technologists (IFT) Hazard assessment – April 2011 Exposure assessment – November 2011 Policy options – April 2012 Dose response for endocrine disruptors – April 2012 Potential conflicts of interest in GRAS additive decisions – August 2013 Workshops held by Pew
  • 7. 6 Navigating the U.S. Food Additive Regulatory Program – 2011 Hazard Assessment Workshop Proceedings – 2011 Exposure assessment Workshop Proceedings – 2013 Looking Back to Look Forward: A Review of FDA’s Food Additives Safety Assessment and Recommendations for Modernizing its Program – June 12, 2013 Data Gaps in Toxicity Testing of Chemicals Allowed in Food in the U.S. – In Press Conflicts of Interest in Approvals of Additives to Food Determined to be GRAS: Out of Balance – August 7, 2013 Capstone Report – Expected August 2013 Articles authored by Pew
  • 8. 7 Evaluation of food additive issues by American Academy of Pediatrics (AAP) “NanoRelease Food Additives” project at International Life Sciences Institute (ILSI) Research Foundation “Endocrine Active Chemicals: Science to Practice” workshop by National Institutes of Health and European Commission Review of regulation and safety assessments outside the U.S. by Berna Magnuson and Cantox International “Chemical Testing in the 21st Century” workshop by the Environmental Defense Fund Related research supported by Pew
  • 9. 88 Basics ~ 10,000 chemicals allowed to be added to food ~ 3,000 not reviewed by FDA ~ 1,000 unknown to FDA Concerns about GRAS & implications for FDA’s science and reassessment of old decisions
  • 10. 99 Generally Recognized as Safe (GRAS) exemption In 1958 Congress exempted use of GRAS additives from Food Additive Petition requirement FDA allows manufacturers to make GRAS safety determinations without notifying the agency Since 1997, FDA has encouraged voluntary notifications of GRAS determinations. FDA review results in: No questions letters Insufficient basis letters Cease to evaluate letters Over the past 10 years, GRAS Notifications outnumber Food Additive Petitions by more than 14 to 1 for direct additives
  • 11. 10 “One of FDA’s principal missions is to ensure the safety of the nation’s food supply, but a growing number of substances that companies have determined are GRAS may effectively be excluded from federal oversight.” “However, FDA may be constrained in detecting any such future problems because it lacks information about an unknown number of substances companies have determined to be GRAS without informing the agency.” “[W]ithout issuing guidance on how to prevent conflicts of interest and information in companies’ GRAS notices regarding expert panelists’ independence, FDA has less assurance of the independence of the experts companies employ to support their GRAS determinations.” 2010 GAO GRAS Report
  • 12. 11 Recommendation: Develop a strategy to minimize the potential for conflicts of interest in companies’ determinations. Status: As of May 2012, FDA has not decided what, if any, actions it will take. FDA comments: Requested comments on several GAO recommendations on December 28, 2010 Reviewing comments received Conflicts of interest: GAO Recommendation #4
  • 13. 1212 Conflicts of Interest in Approvals of Additives to Food Determined to be GRAS: Out of Balance Journal of American Medical Association Internal Medicine Available on-line on August 7, 2013 Authors Tom Neltner, Heather Alger and Maricel Maffini of Pew Lisa Bero of University of California San Francisco Sheldon Krimsky of Tufts University James O’Reilly of University of Cincinnati Evaluates 451 GRAS Notices voluntarily submitted to FDA from 1997 to 2012 Analysis based on framework in Institute of Medicine’s (IOM) 2009 Report on “Conflicts of Interest in Medical Research, Education and Practice”
  • 14. 1313 IOM framework to analyze conflicts of interest COI = “Set of circumstances that creates a risk that the professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.” Primary interest = Ensuring use is GRAS consistent with law Secondary interest = Potential for financial gain to additive manufacturer Does not evaluate specific decisions
  • 15. 1414 Assessing severity of COI: 2 part analysis Likelihood that a decision could be unduly influenced by COI Value of secondary interest Scope of relationship Extent of discretion Seriousness of possible harm if the decision was influenced Value of primary interest Scope of the consequences Extent of accountability
  • 16. 15 Likelihood that evaluation would be unduly influenced by the financial interests of an additive manufacturer* Greaterlikelihoodof undueinfluence Category of decision-maker 1. Employee of additive manufacturer 2. Employee of consulting firm selected by additive manufacturer 3. Expert panel selected by firm or manufacturer 4. Standing expert panel selected by third party 5. Employee of the FDA * Using Institute of Medicine 2009 framework
  • 17. 16 Seriousness of possible harm IF evaluation is unduly influenced by the financial interests of an additive manufacturer* Greaterseriousness ofharm Type of FDA review 1. No review 2. FDA reviews but does not make notice publicly available 3. FDA reviews and makes notice publicly available * Using Institute of Medicine 2009 framework
  • 18. 1717 Results Types of individuals making determinations Frequency of experts serving on panels FDA actions when not notified
  • 19. 1818 Type of individuals making GRAS evaluations submitted to FDA Decision-maker Number of notices Employee of additive manufacturer 101 (22.4%) Employee of consulting firm selected by additive manufacturer 60 (13.3%) Expert panel selected by firm or manufacturer 290 (64.3%) Standing expert panel selected by third party 0 (0%)
  • 20. 1919 10 individuals served most frequently on the expert panels making GRAS evaluations Individual Number of expert panels served on #1 128 (44.1%) #2 41 (14.1%) #3 40 (13.8%) #4 38 (13.1%) #5 35 (12.1%) #6 34 (11.8%) #7 34 (11.8%) #8 28 (9.7%) #9 28 (9.7%) #10 27 (9.3%)
  • 21. 2020 FDA actions when not notified Considered 1997 to 2012 1 action when FDA sought to obtain GRAS safety determination for which it had not been notified Caffeine in alcohol beverages
  • 22. 2121 Limitations Did not evaluate determinations: Not voluntarily sent to FDA Made by Flavor and Extract Manufacturers Association’s (FEMA) Expert Panel Only considered employment of individuals Does not prove COI actually compromised GRAS determination process Individual integrity Organizational policies No conflict between short-term gain and long-term brand Due to insufficient information
  • 23. 2222 Conclusions Financial conflicts of interest were ubiquitous in GRAS determinations by additive manufacturers Raises concern about: Integrity of the process Whether it ensures safety of the food supply Particular concern when manufacturer does not notify FDA FDA should: Require it be notified of all GRAS determinations and of financial COIs Make public all GRAS determinations including those by FEMA for flavors
  • 24. Discussion Draft of Pew’s “Guidance for Industry Selection of Experts Conducting GRAS Evaluations” Tom Neltner Project Director, Food Additives Project The Pew Charitable Trusts
  • 25. 11 Overview Purpose But first . . . Four questions Exemptions Comparison to similar programs
  • 26. 22 Purpose of draft guidance Address shortcomings raised by Pew and U.S. Government Accountability Office (GAO) Provide FDA with specific language to implement recommendation from GAO in 2010 regarding Conflicts of Interest (COI). GAO said FDA should develop a strategy to minimize the potential for conflicts of interest in companies’ determinations. On 12/28/10, FDA requested comments on COI and other issues 10 of 17 comments received addressed COI All 10 supported FDA issuing guidance 2 said FDA should only act if it felt guidance necessary One suggested FDA consider clinical investigator standards at 21 CFR Part 54
  • 27. 33 But first . . . Unlike regulations, guidance documents are not binding Draft guidance would not apply to the following situations because they are not eligible for GRAS exemption: Color additives, pesticides or animal drugs Uses inconsistent with FDA’s food additive regulations for specific additive use Significantly different conditions of use from those allowed in FDA’s GRAS affirmation regulations
  • 28. 44 Exemptions from proposed draft guidance When decision does not qualify for GRAS exemption When new use is within the same general food category and is performing the same physical or technical functional effect as an existing use (43 food categories at 21 CFR 170.3) If estimated daily intake is less than 1% of acceptable daily intake When change does not involve significant changes in the raw materials or increase in portion of particles less than 100 nanometers in size.
  • 29. 55 Key resources FDA’s 2008 guidance on determining COI and eligibility for participation in its advisory committees Institute of Medicine’s 2009 “Conflict of Interest in Medical Research, Education and Practice” Report Flavor and Extract Manufacturers Association’s Expert Panel COI policy European Food Safety Authority’s (EFSA) policy on independence and scientific decision-making processes regarding declarations of interests World Health Organization (WHO) policy on conflict of interest for expert committee on food additives
  • 30. 66 Four questions to industry should answer before selecting an expert: Does the expert have the necessary expertise? Do the experts have sufficient diversity of experience and knowledge to objectively represent the consensus of the scientific community? Is the expert disqualified because of serious financial conflicts of interest? Are there non-financial conflicts of interest that need to be considered?
  • 31. 77 Q1: Does the expert have the necessary expertise? Experts need to know FDA’s guidance in their field Substance characterization needed for: Substance not previously used in food Significant manufacturing process changes Hazard assessment Typically yes, especially when acceptable daily intake not generally recognized Exposure assessment Typically yes, especially when estimated daily intake not generally recognized
  • 32. 88 Q2: Do the experts have sufficient diversity of experience and knowledge to objectively represent the consensus of the scientific community? Sufficient understanding of the broad scientific literature Aware of opinions or published articles, especially those with differing views. Not author of pivotal data. (The person could prepare dossier but not make decision.)
  • 33. 99 Q3: Is the expert disqualified because of serious financial conflicts of interest? Yes, if person would be disqualified because of a financial COI from serving on an FDA advisory committee Steps (see Appendix 2 for details): Identify financial connections Determine if decision would “direct and predictable effect” on those financial connections Determine if there is a “disqualifying financial interest” Waiver option not available
  • 34. 1010 Q4: Are there non-financial conflicts of interest that need to be considered? Knowledge of the identity of the firm (FEMA) Contact with firm during deliberations (FEMA) Expert testimony indicating bias to interests (WHO-JECFA) Other than a food safety organization: Membership on managing body of a public or private entity with interest in decision (EFSA) Membership on a scientific advisory body with a right to influence that body’s decisions where body has interest in decision (EFSA) Providing advice even for free to trade associations with an interest in the decision (EFSA)
  • 35. 1111 Next steps We plan to submit draft guidance on Monday, August 18 If you send us your written comments by Wednesday, August 14, we will include them in our submission to FDA We will share with FDA copy of webinar and any written comments received
  • 36. 12 For more information on Pew’s Food Additive Project Contact: Tom Neltner, Project Director The Pew Charitable Trusts 202.540.6475 tneltner@pewtrusts.org www.pewtrusts.org