Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D....
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Transcript of Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D....
![Page 1: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/1.jpg)
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Dietary SupplementsPublic Meeting
November 15, 2004
George A. Burdock, Ph.D.Diplomate, American Board of Toxicology
Fellow, American College of Nutrition
![Page 2: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/2.jpg)
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A Conservative Response by the Agency
Legitimate dietary supplements
Out of reach of the consumer
Underground/unregulated products
–Spurious claims
–Unsafe products
![Page 3: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/3.jpg)
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Dietary Supplement Market
• Strong consumer market & driving forces– Quality of life issues– Lionizing of natural remedies– Reaction to high cost of drugs
• Strong consumer market– Encourages enterprise– Encourages competition
![Page 4: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/4.jpg)
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Dietary SupplementsThe Players and the Tension
FDA
ConsumerIndustry
Greater AccessFr
ee S
peec
h
Consumer Demand
Effic
acy Safety
Return on Investment
![Page 5: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/5.jpg)
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A Conservative Response by the Agency
May affirm some strongly held beliefs
• Conspiracy theories about “big pharma”
• We ignore the wisdom of our elders
• We ignore the beneficence of ‘mother earth’
![Page 6: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/6.jpg)
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DSHEA as a Safety Valve
• DSHEA was a safety valve in response to a conservative posture by FDA
• Locking the valve– Consumers will lose faith in the Agency– Will give rise to
• Underground• Uncontrolled• Unsafe• Wild, wild west
![Page 7: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/7.jpg)
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The Players and the Tension
FDA is the key player
FDA the Engine for Resolution
![Page 8: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/8.jpg)
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Three Steps Forward
1. Promote the use of Independent Experts
2. Initiate a Notification program
3. Permit a term of exclusivity
![Page 9: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/9.jpg)
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Independent Experts
• Precedent– GRAS for food ingredients– GRASE (…safe and effective) for drugs– FDA Advisory Committees
• Fact Sheet – Strategy for Dietary Supp.– Third party review
• Future?– Health Independence Information Act -
HR 4004
![Page 10: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/10.jpg)
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Notification Program
• Examples– GRAS Notification– NDIN
• Advantages– Public information and safety– Assured vendors
![Page 11: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/11.jpg)
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Term of Exclusive Marketing Rights
• Precedent– Food additive master files– Drug master files
• Will drive investment– Fund safety studies– Fund efficacy studies
• Return on investment required
![Page 12: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/12.jpg)
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Term of Exclusivity
Consumerdemand
Manufact.
R&D
Safety testing
Efficacy testing
$?
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Term of Exclusivity
Consumerdemand
Manufact.
R&D
Safety testing
Efficacy testing
$
No objection
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Term of Exclusivity
Consumerdemand
Manufact.
R&D
Safety testing
Efficacy testing
Manufacturing& Distribution
Marketing
$
No objection
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www.burdockgroup.com
Term of Exclusivity
Consumerdemand
Manufact.
R&D
Safety testing
Efficacy testing
Manufacturing& Distribution
Marketing
$
No objection
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Term of Exclusivity
Consumerdemand
Manufact.
R&D
Safety testing
Efficacy testing
Manufacturing& Distribution
Marketing
$
"Pirate"
$?
No objection
X
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www.burdockgroup.com
Term of Exclusivity
Consumerdemand
Manufact.
R&D
Safety testing
Efficacy testing
Manufacturing& Distribution
Marketing
$
"Pirate"
$?
No objection
X X
No ROI
![Page 18: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/18.jpg)
www.burdockgroup.com
Three Steps Forward
1. Promote the use of Independent Experts
2. Initiate a Notification program
3. Permit a term of exclusivity
![Page 19: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/19.jpg)
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Independent Expert Review& FDA Notification
Dossier Approved by Independent Experts
(1) Safety & Proposed claim (2) Supporting evidence
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Independent Expert Review& FDA Notification
Dossier Approved by Independent Experts
(1) Safety & Proposed claim (2) Supporting evidence
Criteria Reviewed by Agency
Claim & sup-porting evidence(Limited Review
Criteria)• Experts qualified
“…by training and experience…• Rationale sup- porting claim
• Credibility of sup- porting data
Confidential submissionTo Agency
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www.burdockgroup.com
Independent Expert Review& FDA Notification
Dossier Approved by Independent Experts
(1) Safety & Proposed claim (2) Supporting evidence
Criteria Reviewed by Agency
Claim & sup-porting evidence(Limited Review
Criteria)• Experts qualified
“…by training and experience…• Rationale sup- porting claim
• Credibility of sup- porting data
Inadequate
Confidential submissionTo Agency
DecisionBy Agency
No Public NoticeReturned to Submitter
![Page 22: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/22.jpg)
www.burdockgroup.com
Independent Expert Review& FDA Notification
Dossier Approved by Independent Experts
(1) Safety & Proposed claim (2) Supporting evidence
Criteria Reviewed by Agency
Claim & sup-porting evidence(Limited Review
Criteria)• Experts qualified
“…by training and experience…• Rationale sup- porting claim
• Credibility of sup- porting data
No objection
Public NoticeBy Agency
Inadequate
Confidential submissionTo Agency
DecisionBy Agency
No Public NoticeReturned to Submitter
![Page 23: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/23.jpg)
www.burdockgroup.com
Independent Expert Review& FDA Notification
Dossier Approved by Independent Experts
(1) Safety & Proposed claim (2) Supporting evidence
Criteria Reviewed by Agency
Claim & sup-porting evidence(Limited Review
Criteria)• Experts qualified
“…by training and experience…• Rationale sup- porting claim
• Credibility of sup- porting data
No objection FDA Website “Truthful Statement”
(the claim)Product identityManufacturerSafety data
Public NoticeBy Agency
Inadequate
Confidential submissionTo Agency
DecisionBy Agency
No Public NoticeReturned to Submitter
![Page 24: Www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American.](https://reader030.fdocuments.in/reader030/viewer/2022032611/56649d045503460f949d7323/html5/thumbnails/24.jpg)
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Term of Exclusivity
Public Release
(immediate)
• Safety information• Claim• Product name &
manufacturer
Sequestered Info.
(~5 years)
• Supporting evidence for claim
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Independent Expert Review& FDA Notification
• Relieve the logjam of petitions• Benefit from the knowledge of
independent experts• Respond to consumer demands for empowerment
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Term of Exclusivity
Ensure ROI
• Respond to consumer demands for a variety of products
• Ensure products are properly vetted• Ensure competition in marketplace
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Resolution• Consumers
– Empowerment - greater access to new discoveries/enhancement of QoL
– Drug cost savings
• Industry– Free speech assured– Return on investment
• FDA– Ensure consumer safety– Ensure efficacy (no mis-labeling)
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www.burdockgroup.com
Dietary SupplementsPublic Meeting
November 15, 2004
George A. Burdock, Ph.D.Diplomate, American Board of Toxicology
Fellow, American College of Nutrition