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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
ƒ The integrity of worldwide pharmaceutical supply has
been challenged
ƒ Joint responsibility to address this mounting public health
concern
ƒ We need to ensure the integrity of medicines delivered to
our patients
ƒ Existing industry practices must change
© 2005
Securing Pharmaceutical Supply
RFID and Electronic Track & Trace
ƒ Johnson & Johnson’s Perspective
ƒ Key Industry Questions
ƒ Areas for FDA Guidance
ƒ Proposed Industry Actions
© 2005
Facts About Counterfeit Prescription
Drugs1
ƒ More than 10% of drugs worldwide are counterfeit
ƒ In 2000, FDA opened 6 counterfeit drug cases; in 2004,
they opened 58
ƒ Increasingly sophisticated methods used to introduce
counterfeit drugs into the legitimate US market
ƒ 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
© 2005
A Secure Supply Chain:
Our Collective Obligation
ƒ Securing supply is one of the most critical issues for our
industry
ƒ 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
© 2005
Major Areas of Concern
ƒ Difficulty in identifying counterfeit drugs due to increased
sophistication of perpetrators
ƒ Numerous potential entry points to the legitimate supply
chain
ƒ Proliferation of Internet pharmacies poses new
challenges requiring unique solutions
ƒ No system in place to track & trace product (pedigree)
© 2005
Specific Actions – RFID & Pedigree
ƒ Joined MIT Auto-ID Labs
ƒ Formed a Johnson & Johnson RFID Research Center,
ƒ Tested various frequency of tags,
ƒ Participated in industry pilots, and
ƒ Led and participated in industry standards groups
–
EPCglobal HLS, Unified Drug Pedigree Council, etc.
© 2005
No Single Solution
ƒ Policy
–
–
Uniform pedigree
Responsibilities of parties
ƒ Process
–
Changes to industry practices
ƒ Technology
–
–
–
Track, trace, and authenticate
Product differentiation/packaging
Surveillance
© 2005
Challenge Conventional Policy & Practices
ƒ Tracking & tracing product flow is no longer optional
ƒ We believe alternate source purchasing should be
eliminated
ƒ Repackaging operations should be regulated by FDA
ƒ Returned goods should only be restocked after pedigree
review and assurance that product has been
stored/handled properly
ƒ Stringent destruction requirements must be enforced
© 2005
Implement New Technology
Industry Wide Track & Trace
ƒ Manufacturers tagging product is only a start
ƒ A secure supply chain will also require that all parties
involved in the distribution chain participate in
authenticating products
ƒ 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
ƒ Authentication of packages by supply chain parties are
the foundation to electronic track & trace
ƒ Continuing investments must be made to ensure system
is not defeated by counterfeiters
© 2005
Track & Trace Solutions
RFID, Serialization, Pedigree
ƒ We have been actively studying and piloting RFID and
EPC
ƒ 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
ƒ Pedigrees using a uniform code will help protect the drug
supply
ƒ Our evaluations have demonstrated that no one party
can solve the problem independently
© 2005
RFID/EPC and Privacy
ƒ Consumers should be given notice whenever RFID/EPC is
deployed
ƒ 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
ƒ RFID must be adopted in conformance with regulatory
laws as well as our own consumer privacy and security
policies
© 2005
Key Industry Questions
ƒ What business practices need to change?
ƒ What technology standards are needed?
ƒ What tag frequencies will be used?
ƒ What information will be on the tag?
ƒ Will the NDC number be included in the Electronic
Product Code?
ƒ How will the information be stored, secured and
accessed?
© 2005
Possible Areas for FDA Guidance
ƒ Electronic pedigree information content,
ƒ Utilization of digital signature to sign the pedigree,
ƒ Inclusion of the NDC in the electronic product code, and
ƒ Compatibility of bar code information with the
information on the RFID tag
© 2005
Proposed Industry Actions
1. Industry standards that specify how RFID will be
deployed must be developed and broadly implemented.
ƒ
Continue EPCglobal standards process - tag frequency,
product numbering, pedigree exchange, data access, data
security, etc.
2. 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.
3. A comprehensive industry adoption program must be
initiated, including representation from all supply chain
parties with clearly defined milestones.
© 2005
Moving Forward Together
ƒ It is our responsibility to do everything we can to ensure
that our patients get exactly the medication they are
prescribed
ƒ Manufacturers, Distributors, and Healthcare Providers
must work together to find effective solutions to ensure
patient safety
© 2005