Ken Falci Ph D Director OSAS Center for

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

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

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

WHAT Does the FDA Want to Accomplish with CAERS? Ø Address Serious Adverse Events Ø Track and Monitor Adverse Events Ø Analyze for Trends (Consumer Complaints) Ø 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? Ø All identifying information of Non-FDA people and places Names and addresses Where consumer purchased product Ø Medical Records Insurance Information Autopsy Numbers Signatures / Initials Date of Birth

What is not Redacted? Ø Ø Ø Ø 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? Ø Daily Downloads (FDA Field and Follow-up) Ø Phone Calls, 800#s, and Letters Ø AERS Drug links

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

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

Firm Letter Notification (FY-2003) Ø Ø Ø Ø 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 Ø Invite Industry and Consumer Input Ø Looking for the best information that is useful and meaningful Ø Case #/firm/product/ingredient/symptom Ø Cause and effect / FDA opinion?

WHAT’S in CAERS’ FUTURE? Ø FY-2003 Ø FY-2004 Build links to Drug AERS Build links to Med. Watch FY-2005 Complete legacy data transfer Build a link to Poison Control Ø Ø FY-2006 Go Operational by June 2003 Receive FDA field downloads Build Thesauri for Ingredients, Products and Botanicals