# Presentation: 411152

## Industry Adoption of RFID and Electronic Track & Trace

- Mike Rose
- Vice President
- Johnson & Johnson Corporate
- RFID / EPC Global Value Chain
- February 8, 2006

## A Secure Supply Chain:Our Collective Obligation

- The integrity of worldwide pharmaceutical supply has been challenged
- Joint responsibility to address this mounting public health concern
- We need to ensure the integrity of medicines delivered to our patients
- Existing industry practices must change

## Securing Pharmaceutical SupplyRFID and Electronic Track & Trace

- Johnson & Johnson’s Perspective
- Key Industry Questions
- Areas for FDA Guidance
- Proposed Industry Actions

## Facts About Counterfeit Prescription Drugs1

- More than 10% of drugs worldwide are counterfeit
- In 2000, FDA opened 6 counterfeit drug cases; in 2004, they opened 58
- Increasingly sophisticated methods used to introduce counterfeit drugs into the legitimate US market
- Counterfeit products entered the supply chain where existing business practices were insecure and where legitimacy of business partners was unknown
- 1 FDA COMBATING COUNTERFEIT DRUGS - February, 2004

## A Secure Supply Chain:Our Collective Obligation

- Securing supply is one of the most critical issues for our industry
- We must
- Ensure that patients and healthcare professionals receive genuine products that are 100% pure to original form
- Have manufacturers, distributors and government work together to ensure patient safety
- Strive for continuous improvement
- Policy
- Process
- Technology
- Acceptable practices of the past will not ensure the security of supply in the future

## Major Areas of Concern

- Difficulty in identifying counterfeit drugs due to increased sophistication of perpetrators
- Numerous potential entry points to the legitimate supply chain
- Proliferation of Internet pharmacies poses new challenges requiring unique solutions
- No system in place to track & trace product (pedigree)

## Specific Actions – RFID & Pedigree

- Joined MIT Auto-ID Labs
- Formed a Johnson & Johnson RFID Research Center,
- Tested various frequency of tags,
- Participated in industry pilots, and
- Led and participated in industry standards groups
- EPCglobal HLS, Unified Drug Pedigree Council, etc.

##    No Single Solution 

- Policy
- Uniform pedigree
- Responsibilities of parties
- Process
- Changes to industry practices
- Technology
- Track, trace, and authenticate
- Product differentiation/packaging
- Surveillance

## Challenge Conventional Policy & Practices

- Tracking & tracing product flow is no longer optional
- We believe alternate source purchasing should be eliminated
- Repackaging operations should be regulated by FDA
- Returned goods should only be restocked after pedigree review and assurance that product has been stored/handled properly
- Stringent destruction requirements must be enforced

## Implement New TechnologyIndustry Wide Track & Trace 

- Manufacturers tagging product is only a start
- A secure supply chain will also require that all parties involved in the distribution chain participate in authenticating products
- Authentication will require a continued investment in human and financial resources to maintain and update accurate pedigrees and to provide transparency throughout the supply chain
- Authentication of packages by supply chain parties are the foundation to electronic track & trace
- Continuing investments must be made to ensure system is not defeated by counterfeiters

## Track & Trace SolutionsRFID, Serialization, Pedigree

- We have been actively studying and piloting RFID and EPC
- Mass serialization has great potential for tracking & tracing of products
- Serialized linear and 2D-data matrix bar codes can be used until RFID is more widely adopted
- Pedigrees using a uniform code will help protect the drug supply
- Our evaluations have demonstrated that no one party can solve the problem independently

## RFID/EPC and Privacy

- Consumers should be given notice whenever RFID/EPC is deployed
- To the greatest extent possible, end users of our products should have the option of disabling or removing RFID tags when they are no longer needed
- RFID must be adopted in conformance with regulatory laws as well as our own consumer privacy and security policies

## Key Industry Questions

- What business practices need to change?
- What technology standards are needed?
- What tag frequencies will be used?
- What information will be on the tag?
- Will the NDC number be included in the Electronic Product Code?
- How will the information be stored, secured and accessed?

## Possible Areas for FDA Guidance

- Electronic pedigree information content,
- Utilization of digital signature to sign the pedigree,
- Inclusion of the NDC in the electronic product code, and
- Compatibility of bar code information with the information on the RFID tag

## Proposed Industry Actions

- Industry standards that specify how RFID will be deployed must be developed and broadly implemented.
- Continue EPCglobal standards process - tag frequency, product numbering, pedigree exchange, data access, data security, etc.
- Business practices must be modified to ensure that all supply chain parties are reading the information on the RFID tag and properly maintaining and disclosing the electronic drug pedigree.
- A comprehensive industry adoption program must be initiated, including representation from all supply chain parties with clearly defined milestones.

## Moving Forward Together

- It is our responsibility to do everything we can to ensure that our patients get exactly the medication they are prescribed
- Manufacturers, Distributors, and Healthcare Providers must work together to find effective solutions to ensure patient safety