1. Ken Falci, Ph.D.,Director, OSAS Center for Food Safety and Applied Nutrition (CFSAN) FDA, College Park, MD

3. CAERS Why does the FDA need CAERS? What does the FDA want to accomplish?

4.  Recognized Need for an Improved System  Combined Old Computer Systems  Security  International Adverse Events  Counter Terrorism Tool CAERS WHY is the FDA Developing CAERS?

5.  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?

6. 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

7. 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

8. What is not Redacted?  Names of Members of Congress  Gender  Age  Date of Death  Manufacturers  FDA tracking numbers  Symptom

9. A PASSIVE VS. An ACTIVE SYSTEM CAERS CAERS is Passive but all Inclusive 7000 Voluntary Adverse Events and Consumer Complaints Mandatory Adverse Event Reporting?

10.  Daily Downloads (FDA Field and Follow-up)  Phone Calls, 800#s, and Letters  AERS Drug links HOW Does CAERS Work?

13. Field Accomplishments and Compliance Tracking System (FACTS)  Industry Codes 54 Dietary Supplements 53 Cosmetics 40 Infant and Junior Food Product

14.  Computer Design Requirements  New Document Management System  Pilot Operations Ongoing  Training  Searching capabilities WHAT Have We Done So Far with CAERS?

15. 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

20. Limited Resources Not Consumer Friendly Limited Fields/Trends Lack of Accurate Information Hard to Search Updating Problems Concentrate on CAERS CAERS Remove the Dietary Supplement Adverse Event Website? Why Did CAERS Remove the Dietary Supplement Adverse Event Website?

21.  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

22. 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-2005Complete legacy data transfer Build a link to Poison Control  FY-2006 Build Thesauri for Ingredients, Products and Botanicals