Transcript CFSAN Presentation of the New CAERS

Ken Falci, Ph.D.,Director, OSAS
Center for Food Safety
and
Applied Nutrition
(CFSAN)
FDA, College Park, MD
Why does the FDA need CAERS?
What does the FDA want to accomplish?
WHY is the FDA Developing
CAERS?
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Recognized Need for an Improved System

Combined Old Computer Systems
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Security
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International Adverse Events

Counter Terrorism Tool
WHAT Does the FDA Want to
Accomplish with CAERS?
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Address Serious Adverse Events

Track and Monitor Adverse Events

Analyze for Trends (Consumer Complaints)
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Speed the Time of Review
What is an Adverse Event?
An illness or injury to an individual alleged to
be caused by the use of a product.
MINIMUM DATA NEEDED
– Adverse event
– Manufacturer
– Injured Person
– Report date
– CFSAN Product
What Is Redacted from
Adverse Event Reports?

All identifying information of Non-FDA
people and places
Names and addresses
Where consumer purchased product

Medical Records
Insurance Information
Autopsy Numbers
Signatures / Initials
Date of Birth
What is not Redacted?
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Names of Members of Congress
Gender
Age
Date of Death
Manufacturers
FDA tracking numbers
Symptom
A PASSIVE VS. An ACTIVE SYSTEM
CAERS is Passive but all Inclusive
7000 Voluntary Adverse Events and
Consumer Complaints
Mandatory Adverse Event Reporting?
HOW Does CAERS Work?

Daily Downloads
(FDA Field and Follow-up)

Phone Calls, 800#s, and Letters

AERS Drug links
Field Accomplishments
and
Compliance Tracking System (FACTS)
 Industry
54
53
40
Codes
Dietary Supplements
Cosmetics
Infant and Junior Food
Product
WHAT Have We Done
So Far with CAERS?

Computer Design Requirements

New Document Management System

Pilot Operations Ongoing
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Training

Searching capabilities
Firm Letter Notification (FY-2003)
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Informational/Transparency (share knowledge)
Sent to manufacturer address on report or as
designated
Only illness or injury
FDA verification and validation (Fraud)
Redacted for personal identifiers
Ask for other industry reports
Disclaimer
Why Did CAERS Remove the Dietary
Supplement Adverse Event Website?
Limited Resources
Not Consumer Friendly
Limited Fields/Trends
Lack of Accurate Information
Hard to Search
Updating Problems
Concentrate on CAERS
The New CAERS Website

Invite Industry and Consumer Input
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Looking for the best information
that is useful and meaningful
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Case #/firm/product/ingredient/symptom
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Cause and effect / FDA opinion?
WHAT’S in CAERS’ FUTURE?
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FY-2003 Go Operational by June 2003
Receive FDA field downloads
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FY-2004 Build links to Drug AERS
Build links to MedWatch
FY-2005 Complete legacy data transfer
Build a link to Poison Control
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FY-2006 Build Thesauri for Ingredients,
Products and Botanicals