# Presentation: 498724

## FDA Anti-Counterfeit Drug Initiative Workshop   Public MeetingFebruary 8 and 9, 2006

- Thomas McPhillips
- Vice President, U.S. Trade Group
- Pfizer Inc

## Overview

**Share FDA’s Counterfeiting Concern **
- Counterfeit drugs present a significant risk to patient health
**Must Address Counterfeiting on Many Fronts**
- Enhanced business practices;
- Regulatory and legislative solutions;
- Heightened enforcement; and
- Employment of technology.
**Pfizer has Undertaken Initiatives in all These Areas **

## Overview

_**Provide comment on**_**:**
- Pfizer’s Viagra RFID pilot program
- Obstacles to RFID implementation
- Role of FDA
- RFID adoption timetable
- Standards setting process and mass serialization
- Universal pedigree requirements and legislation

## Pfizer RFID Pilot

_**Viagra RFID Initiative**_**:**
- Pilot program aimed at shipping RFID/EPC tagged Viagra and creating an authentication capability by the end of 2005.
- Viagra selected because it is Pfizer’s most frequently counterfeited product.
- All Viagra produced for sale in the U.S. now contains an RFID/EPC tag.

## Pfizer RFID Pilot

_**Key objective of pilot program**_**:**
- Learn more about mass serialization and RFID technology and the business processes its use requires.

## Pfizer RFID Pilot

_**Capabilities created**_:
**Mass serialization capability**
_***Allows***_***:***
- Generation and assignment of unique number to each bottle, case, and pallet of Viagra
- Writing information to high or ultra-high frequency RFID tags
**EPC reading and writing capabilities**
_***Allows***_***: ***High speed application on existing packaging lines
**2 dimensional bar code alignment**
_***Allows***_***: ***Same number assignment for EPC and RFID tag
**Capture and track tag and write/read performance**
**Ability to capture EPC information upon shipment from our logistics centers**
**Authentication capability for wholesalers and pharmacies**

## Pfizer RFID Pilot

_**Key decisions during Viagra pilot**_**:**
- Choice of frequencies
- Read and write to tags on-line vs. pre-written
- No NDC in the EPC numbering scheme
**Privacy first**
- Redundant two dimensional bar code
- Disclosure on label of use of RFID

## RFID Implementation

_**Much to learn and evaluate**_
- Not just about applying a tag
_**Objective of our next phase**_**:**
- How to handle data and exception reporting
- Learn more about wholesalers and pharmacies needs
- Understand business process implications and
- Define ongoing costs

## RFID ImplementationWhat Else is Needed?

- Continued collaboration to obtain real world experience with RFID and mass serialization throughout the distribution channel
- Significant investment required
- Feedback on performance and utility of RFID-tagged product under normal day-to-day use
- Understanding of benefit and effect of targeted or total employment of mass serialization/RFID
- Resolution on data access and sharing
- Research on feasibility of tagging all pharmaceuticals
- Standards decisions and cost effective, robust tags

## How can RFID be implemented? Role of FDA

_**FDA as Facilitator**_** – **FDA should continue to actively participate and, where appropriate, facilitate discussions on feasibility of implementing RFID.
_**Industry as Serialization Leader**_** - **Industry should take lead on how _serialization_ is to be applied both near and long-term.

## How can RFID be implemented? Timetable

_**Timetable **_**– **Numerous issues must be addressed before a specific timetable is established.
**Key Questions:**
- How will data be shared and who will have access?
- Do all pharmaceuticals need to be serialized and tagged for anti-counterfeiting purposes?
- How does the technology perform? Can costs be reduced?

## How can RFID be implemented? Timetable

_**Phase 1**_**: **Tag only “**high-risk**” items
- Adoption possible in near future.
_**Phase 2**_**:** Tag **ALL** items with RFID
- Several additional years will be required with a very substantial investment.

## RFID ImplementationStandards Setting

_**EPCglobal Process**_
- Support the process used by EPCglobal
- Established standards that are driven by business requirements and specific to the pharmaceutical industry
_**Broader Participation Needed**_
_**Guidelines Needed Now**_
- While standards are under development, guidelines on issues such as privacy, EPC numbering schemes, and frequencies should be developed.

## Universal Pedigree

_**Electronic Solution Not an Immediate Fix**_
- Implementation of electronic track and trace system may be many years off
- However, we have an immediate need
_**Solution Needed Now**_** **
- Pedigrees (chain of custody) are necessary in the interim
- Ideally, there should be one way to do this

## States Addressing Issue Through Legislation

_**Key components**_: _** **_
**Stricter Licensing and Bonding Requirements**
**Inclusion of Normal Distribution Concept**
- Pedigrees should be required when the drug leaves the “normal distribution channel.”
- System could apply more broadly when electronic system operational.

## States Addressing Issue Through Legislation

_**States Have Made Tremendous Strides in Enacting Pedigree Laws**_
- A few select examples include Arizona, California, Florida, Indiana, Iowa, New Jersey, New Mexico, Nevada, Oklahoma, and Texas.
_**Continued Pfizer Support**_
- Pfizer supports these initiatives