ken falci, ph.d.,director, osas center for food safety and applied nutrition (cfsan) fda, college...
TRANSCRIPT
Ken Falci, Ph.D.,Director, OSAS
Center for Food Safety and
Applied Nutrition (CFSAN)
FDA, College Park, MD
Why does the FDA need CAERSCAERS?
What does the FDA want to accomplish?
Recognized Need for an Improved System
Combined Old Computer Systems
Security
International Adverse Events
Counter Terrorism Tool
WHY is the FDA Developing CAERSCAERS?
Address Serious Adverse Events Track and Monitor Adverse Events
Analyze for Trends (Consumer Complaints)
Speed the Time of Review
WHAT Does the FDA Want to Accomplish with CAERS?
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 placesNames and addresses
Where consumer purchased product
Medical RecordsInsurance Information
Autopsy Numbers
Signatures / Initials
Date of Birth
What is not Redacted?
Names of Members of Congress Gender Age Date of Death Manufacturers FDA tracking numbers Symptom
A PASSIVE VS. An ACTIVE SYSTEM
CAERSCAERS is Passive but all Inclusive
7000 Voluntary Adverse Events and Consumer Complaints
Mandatory Adverse Event Reporting?
Daily Downloads (FDA Field and Follow-up)
Phone Calls, 800#s, and Letters
AERS Drug links
HOW Does CAERS Work?
Field Accomplishments and
Compliance Tracking System (FACTS)
Industry Codes
54 Dietary Supplements
53 Cosmetics
40 Infant and Junior Food Product
Computer Design Requirements
New Document Management System
Pilot Operations Ongoing
Training
Searching capabilities
WHAT Have We Done So Far with CAERS?
Firm Letter Notification (FY-2003)
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
Limited Resources
Not Consumer Friendly
Limited Fields/Trends
Lack of Accurate Information
Hard to Search
Updating Problems
Concentrate on CAERS
Why Did CAERSCAERS Remove the Dietary Remove the Dietary Supplement Adverse Event Website?Supplement Adverse Event Website?
Invite Industry and Consumer Input
Looking for the best information that is useful and meaningful
Case #/firm/product/ingredient/symptom
Cause and effect / FDA opinion?
The New CAERS Website
WHAT’S in CAERS’ FUTURE? FY-2003 Go Operational by June 2003
Receive FDA field downloads
FY-2004 Build links to Drug AERS Build links to MedWatch
FY-2005 Complete legacy data transferBuild a link to Poison Control
FY-2006 Build Thesauri for Ingredients, Products and Botanicals
