Request for Comment -- DHHS Docket No. 2003N-0361 Anti-Counterfeit Drug
Initiative

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1.  Introduction

Sun Microsystems, Inc. (Sun) is pleased to provide input in the
formulation of the Food and Drug Administration\'s (FDA) Final Report
and recommendations in the fight against counterfeit drugs. Sun\'s
comments focus on track and trace as well as infrastructure technologies
which can be used by the Government and industry to help follow products
throughout their life-cycle and ensure product authenticity from origin
to consumer.

2.  Sun Overview

Sun is a leading, worldwide provider of products, services and support
solutions for building and maintaining network computing environments.
Sun sells scalable computer and storage systems, high-speed
microprocessors, and a comprehensive line of high-performance software
for operating network computing equipment. The emergence of network
services has driven Sun to concentrate on the combination of Java
technology and its Sun Open Net Environment (Sun ONE) portfolio to
provide customers with new business opportunities for deploying Web
services and applications through connectivity as well as integration
with existing software systems.

The Sun Open Net Environment (Sun ONE) is Sun's vision, architecture,
platform, and expertise for delivering Services on Demand today and in
the future. Based on open standards such as Java and XML technology, the
Sun ONE software suite provides a highly scalable and robust framework
for building and deploying a variety of Services on Demand \-- from
traditional Web-based applications to future context-aware Web services.
By simplifying the way Web services are created, assembled, and
deployed, the Sun ONE platform can enhance productivity, speed time to
market, and increase business opportunities for enterprises and service
providers worldwide.

Sun also provides a broad range of services, including support services,
professional services, and education. Sun\'s products are used for many
commercial and technical applications in various industries including
telecommunications, financial services, manufacturing, government,
education and research, retail, health care, digital media, and
entertainment. Sun utilizes open industry standards, the Solaris
Operating Environment, and the UltraSPARC (Ultra Scalable Processor
Architecture) microprocessor. Sun is well-known for a string of
continuous innovations, including NFS, Java, Jini, XML, and Project JXTA
technologies. Sun harnessed these technology disruptions and turned them
into a series of disruptive innovations, which eventually led to the
creation of new standards in the marketplace. Customers benefited from
knowing that products based on these standards would play nicely in the
enterprise. And developers benefited from knowing that applications
adhering to these standards would benefit from cross-platform support.
In addition, Sun is committed to investment in and ownership of
intellectual property, leveraging our relationships with industry
leaders, and enabling the Internet and network-based business solutions,
as further described in this response.

Sun\'s vision has historically been to ensure that network services are
available to anyone, anywhere, anytime, using any device. Sun\'s
comments below address how RFID and Auto-ID are technologies which
demonstrate this vision, with RFID as a key enabler of "The Internet of
Things" vision.

**Overview of Auto-Identification (Auto-ID) Technology**

Automatic identification (Auto-ID) is a broad term given to a set of
technologies that are used to help machines identify objects. For
purpose of these comments, Auto-ID is about "tagging" physical objects -
pharmaceuticals - so that they may be *uniquely* and *easily*
identified, ideally without human intervention. Computers and reader
devices are equipped to detect the tagged objects (vials or other unit
of packaging). This technology infrastructure can then be used to track,
monitor, trigger events or even perform actions on the identified
objects.

While the earliest adopters of this technology are large retailers and
consumer product goods suppliers seeking to reduce product losses and
supply chain costs, Auto-ID technology can greatly enhance the FDA and
the pharmaceutical industry\'s ability to manage the supply chain and
authenticity of supply of drugs as they move throughout the supply
chain. In addition to providing the level of item tracking and
authenticity needed for life-critical merchandise such as
pharmaceuticals, the pharmaceutical industry can also take advantage of
this technology to increase overall operational efficiencies.

Auto-ID employes a numbering scheme called the Electronic Product Code
(EPC) which provides a unique ID for any physical object. While today
the EPC can co-exist with the nearly ubiquitous UPC bar code used today,
it is envisioned that the EPC may eventually replace the UPC. Unlike the
UPC which identifies product categories, the EPC is capable of uniquely
defining and distinguishing one particular item from others in the same
batch.

Once assigned, the EPC is encoded into a tiny chip on the Auto-ID or
Radio Frequency Identification (RFID) tag. Tags typically comprise a
RFID chip and a thin flat antenna coiled around the chip that is used to
power the chip as well as to receive commands and transmit EPCs from and
for the chip. There are three types of RFID tags:

1.  Active Tags, which include a battery, typically used for tracking
    high-value goods that need to be scanned over long ranges (i.e.
    railway cars, shipping containers).

2.  Passive Tags have no battery, and draw power from the reader.
    Passive tags cost less than \$.40 today.

3.  Semi-Passive Tags also use a battery to run the local chip\'s
    circuitry, but draw power from the reader like the passive tag.

It is anticipated that as standards are adopted RFID tags will be
applied to drugs as well as many consumer goods during the manufacturing
process, similar to the way that the UPC bar code is used today.

The following table provides a comparison of UPC Bar Codes and RFID
Tags.

  -----------------------------------------------------------------------
                          UPC Bar Codes           Auto-ID RFID Tags
  ----------------------- ----------------------- -----------------------
  Standards-Based?        Yes (UCC/EAN)           Yes (Auto-ID Center,
                                                  UCC/EAN)

  Uniquely Identifies     Yes                     Yes
  Items?                                          

  Room for Growth         No (Mature Standard)    Yes (Presently 256 bits
                                                  but no limitations)

  Automatic Operation     No (Possible by         Yes
                          inconvenient)           

  Mode of Read            Optical (Line of Sight) RF (No line of sight
                                                  limitation)
  -----------------------------------------------------------------------

When the RFID tagged product is in the vicinity of an active reader, the
tagged product will wirelessly echo its EPC to the reader. The EPC is
then used to query a server to obtain more detailed information on the
product. This enables decisions to be made locally - at any step of the
supply chain (ie discard drugs that are not authentic, notify FDA about
counterfeit pharmaceutical, etc.,( as well as trigger events back to the
original manufacturer, distributor, retailer, etc.

Software standards that resolve the unique tag identifier as well as
standards that define the data formats for information flow between
various components are needed in order to achieve the greatest promise
for Auto-ID technology for the FDA as well as the pharmaceutical
industry.

Some of the standards include:

-   Object Name Service (ONS): A standard for looking up unique EPCs and
    pointing computers to information about the item associated with the
    code. ONS is similar to the Domain Name Service or DNS, which points
    computers to sites on the Internet today.

-   PHysical Markup Language (PML): PML is a new standard in which all
    the useful information about the product is written. PML is based on
    XML, adopted today by the FDA for use for electronic drug
    application submissions, labeling, etc. PML Servers will respond to
    requests for PML files related to individual EPCs.

These standards are being specified and developed under the auspices of
the Auto-ID Center, headquartered at the Massachusetts Institute of
Technology in Cambridge, Massachusetts. Sun is pleased to be a sponsor
as well as working member of the Auto-ID Center\'s technology board to
help realize the promise of this technology by addressing the complex
technical issues around Auto-ID.

**Why Work with Sun on RFID/Auto-ID Technology Initiatives?**

RFID and Auto-ID requires a tremendous change in information and system
management to realize its huge potential benefits. Auto-ID will require
a new kind of infrastructure consisting of networking, computing power,
storage hardware and software to help the FDA and the pharmaceutical
supply chain make sense of, and act on, this important data that is now
available about a drug. Sun brings the following to the FDA\'s
initiative in pursuing RFID/Auto-ID technology as one effort to help in
the fight against counterfeit drugs:

-   Sun has extensive expertise in developing mission critical hardware
    and software infrastructure to support FDA and the pharmaceutical
    industry\'s adoption of RFID/Auto-ID technologies;

-   Sun is recognized as a leader and visionary the area of
    network-based technologies and is willing to invest with the FDA and
    the pharmaceutical industry to put in place a successful pilot or
    cooperative development implementation.;

-   Sun has iForce Centers available to assist customers - like FDA and
    the pharmaceutical industry, to assist with developing and testing
    Proof of Concept solutions based on available technologies, and
    proven, scalable infrastructure components.

Sun has included a separate Technical White Paper, *Sun\'s Auto-ID
Architecture, June, 2003* with these comments. This paper details Sun\'s
open, standards-based, and scalable solutions for the FDA and industry.
Sun\'s Auto-ID solution set features the following elements essential
for successful deployment of this technology in the fight against
counterfeit drugs:

-   Standards-based Auto-ID Platform- Sun\'s solution is built on
    standards including Auto-ID, Java, J2EE, XML/SOAP, etc.

-   Reliable - Sun\'s solution set is designed for the High Availability
    required for a mission-critical track and trace system.

-   Highly Scalable - Sun\'s solution provides the ability to scale to
    billions of reads, necessary to read to the individual
    pharmaceutical vial or unit packaging.

-   Manageable - Sun\'s solution is designed for remote and distributed
    management to make the solution set easy to deploy for both FDA and
    industry.

-   Secure - Sun\'s infrastructure for RFID technology provides the
    user, group and role-based security necessary to ensure the
    authenticity and safety of the nation\'s pharmaceutical supply
    chain.

-   Integratable - Sun\'s solution provides for seamless integration and
    interoperability with existing Enterprise Applications.

> The remainder of these comments focuses on the specific questions
> raised by the FDA related to technologies like RFID.

**Responses to FDA Technology Questions**

Sun, as a technology vendor, has provided comments related to particular
FDA Questions Concerning Technology, specifically the use of RFID or
Auto-ID technology as an anti-counterfeiting measure. The following
numbering scheme maps directly to the FDA\'s Interim Report Section IV.A
questions:

1\. Discuss the advantages and disadvantages of unit of use packaging.
please provide

any information on the economic impact of requiring unit of use
packaging.

As shown in Sun\'s recent technology demonstration at the FDA\'s public
meeting on this topic, RFID or Auto-ID technology can be employed on all
levels of packaging -f rom the container/box for specific pharmaceutical
vials, to a larger container envisioned at a number of large retailers.
Sun\'s solution stack for RFID technology provides the easy
scalability - of both software and hardware infrastructure components -
to handle the data volumes from the smallest-larger units of use
packaging.

2\. Should the European Union requirements be used as a model for unit
of use packaging?

Sun\'s Auto-ID solution can support, as indicated in response to (1)
above, the appropriate unit of use packaging for the FDA efforts as well
as EU efforts.

3 Discuss the advantages and disadvantages of using tamper evident
packaging on drug products. Please provide any information on the
economic impact of requiring tamper evident packaging features on these
products.

RFID technology can work in conjunction with tamper evident packaging of
drug products.

4\. What anti-counterfeiting technologies are being used? Are there any
data on which

technologies are successful?

Auto-ID/RFID is a new technology that is being actively investigated by
consumer packaged goods companies and retailers to provide an
unprecedented real-time view of assets and inventories throughout the
supply chain. As indicated in presentations at the recent public FDA
meeting, leading pharmaceutical companies, industry groups, and
technology suppliers like Sun all believe that this technology holds
great promise to curtail drug counterfeiting by enabling the FDA and
industry suppliers to effectively track the pharmaceutical supply from
origin to consumer.

5\. What if any minimum number of anti-counterfeiting technologies
should be utilized on packaging and labeling? Should technologies be
utilized on all dosage forms (e.g. APIs, finished dosage forms) and
products or just dosage forms and products at high risk of being
counterfeited?

As costs for infrastructure components (readers, etc.) and tags come
down (similar to the evolution of bar codes in use today),
pharmaceutical manufacturers and the FDA may realize that the RFID
technology should be deployed on not only the products at highest risk
of counterfeit, but on all pharmaceuticals as part of the manufacturing
and distribution process.

6\. Should any specific anti-counterfeiting technologies be utilized?
Should covert technologies always be utilized? Should overt technologies
always be utilized?

Auto-ID/RFID technology for track and trace will likely co-exist with a
variety of specific anti-counterfeiting technologies. including both
covert and overt technologies

7.  Should some anti-counterfeiting technologies only be identifiable by
    the manufacturer and/or the FDA?

For RFID, the technology must be identifiable by the manufacturer and
the pharmaceutical supply chain in order to realize its greatest
potential.

8\. On what dosage forms and products should taggants, other markers or
unique characteristics be utilized? All dosage forms and products? High
risk dosage forms and products? are there unique characteristics of
products that can be utilized in lieu of taggants or chemical markers
for forensic analysis?

See response to question (1) above. Also, the RFID technology could be
incorporated not only into a label on a product, but also into the
packaging itself (ie vial, etc.)

9\. What role should FDA play in reviewing the use of (i)
anti-counterfeiting technologies incorporated into the packaging and
labeling, (ii) taggants markers and other unique characteristics
incorporated in to the product itself, and (iii) track and trace
technologies?

The FDA plays an important role in setting the guidelines for use of
technologies such as RFID in order to promote the usage and greatest
benefit of these technologies for the entire drug supply chain. The FDA
could also play a key role in setting up a cooperative research and
development arrangement or pilot with one or more pharmaceutical
companies to investigate the uses of this technology.

10\. How should validation of an anti-counterfeiting measure or track
and trace technology be determined? Should only validated
anticounterfeiting measures be used? Who should do the validation?

The FDA, in conjunction with industry and technology suppliers like Sun
can help to validate the usefulness and readiness of technologies like
RFID with pilot projects, and cooperative research and development
efforts. FDA could work with industry and technology suppliers to
develop the appropriate architecture necessary to deploy a RFID track
and trace solution. Sun\'s iForce Centers could be used to help validate
real-world scenarios with existing technologies and applications. Sun is
already doing pilot projects in these centers to test the scale,
security and integration of our Auto-ID infrastructure. These efforts
could be extended to include key FDA personnel, pharmaceutical partners,
etc.

11\. Should a database, as described in Technology Option 5 (see
attached for full report), be created? If so, who should develop the
database? Where should it be housed? WHo should have access to the data?
Who should be responsible for updating and maintaining it?

The greatest value of track and trace technologies like RFID, and the
great technology hurdle is in the data that will be made available for
use in identifying counterfeit drugs as well as understanding who will
own this data and manage it. Sun technology provides the scalable
infrastructure to accommodate this massive amounts of data that will be
available. Sun is also eager to participate with the FDA and industry in
formulating the right architecture to ensure that this data is used
effectively and securely.

12\. Discuss the advantages and disadvantages and the role of track and
trace technologies, in particular, bar codes and RFID.

The following table provides a comparison of UPC Bar Codes and RFID
Tags.

  -----------------------------------------------------------------------
                          UPC Bar Codes           Auto-ID RFID Tags
  ----------------------- ----------------------- -----------------------
  Standards-Based?        Yes (UCC/EAN)           Yes (Auto-ID Center,
                                                  UCC/EAN)

  Uniquely Identifies     Yes                     Yes
  Items?                                          

  Room for Growth         No (Mature Standard)    Yes (Presently 256 bits
                                                  but no limitations)

  Automatic Operation     No (Possible by         Yes
                          inconvenient)           

  Mode of Read            Optical (Line of Sight) RF (No line of sight
                                                  limitation)

  Multiple Reads          Sequential              Simultaneous
  -----------------------------------------------------------------------

As noted previously, development of standards and cost of components
(tags, readers, etc.) will drive the mass adoption of RFID, just as it
did the adoption of bar code technology. Initially, Sun believes that
there could be two systems - one for bar codes and one for the RFID
technology. Already, technology vendors are building readers that
accommodate both. Initially, with bar code technology, the cost of the
scanners was a barrier to usage of this technology. Today, that is no
longer the case. However, RFID technology has an advantage over bar code
technology in that it does not require the time or personnel or inherent
human error associated with scanning.

13\. What are the costs and challenges involved with setting up an
infrastructure for utilizing various track and trace technologies?

Sun believes that the following factors are key to setting up an
infrastructure to utilize RFID track and trace technology:

-   Scale is the key to setting up an infrastructure to utilize RFID
    technology. Sun believes that the FDA and industry should focus on
    solution sets that provide an easy, cost-effective way to scale both
    hardware and software infrastructure.

-   Integration and interoperability. In addition, track and trace
    technologies are only as good as the enterprise systems that they
    interface and interoperate with. These technologies produce data and
    this data must be usable in today\'s COTS enterprise supply chain
    products - SAP, Manugistics, etc.

-   Security. Ownership and access to the data obtained from RFID
    technology must be carefully controlled and maintained. The
    infrastructure to supply RFID track and trace technology must be
    able to be secured with role-level, need to know access security
    provisions to ensure the integrity of the data and the information
    flow.

14\. Tracking and tracing drugs and biologics throughout the drug
distribution chain may result in the creation of a large database that
includes tracking data from each entity that \"handles\" the product.
Who should create and maintain such data? Where and how should the data
be housed? Who should have access to this data? How can appropriate
confidentiality be assured?

As noted in response to Question (11), the FDA, in conjunction with
industry and technology partners, should develop an architectural
blueprint to address the best way to maintain and utilize this data.
Solutions must be built not only on a scalable architecture, but an
architecture which lends itself to appropriate security and access
controls.

15\. Are there additional benefits beyond the ability to detect
counterfeit product that anti-counterfeiting and track/trace
technologies can provide for industry (e.g. inventory control,
facilitation of product recalls, and identification of theft and product
diversion)? give specific examples.

As noted previously, organizations that are most interested in track and
trace technologies like RFID/Auto-ID are those that see the tremendous
value in controlling their inventory cycles, managing assets, and
improving business efficiencies. In addition to the tremendous societal
benefits of this type of technology in preventing counterfeit drugs from
reaching consumers and increasing patient/consumer safety, industry will
see the same control over their supply chain and, over time, these
efficiencies should translate into reduced product costs to consumers.
Consumer packaging companies and retailers are only now piloting uses of
RFID technologies to assist and improve their inventory control systems.

16\. Discuss the logistic, economic, and public health effects of direct
shipment of product to retailers and other end users.

RFID track and trace solutions can be deployed in a model where product
is shipped directly to retailers. The FDA should convene a group of
industry and technology partners to map out the appropriate architecture
based on the best model for economies and the public health and welfare.

17\. For products that are shipped directly from manufacturers to
retailers, would the use of track and trace technology on those products
provide any additional benefits?

Track and trace technologies bring the additional economic benefits to
manufacturers as noted in response to Question (15) above. The benefits
of unique identification and tracking of pharmaceuticals for consumer
safety and assurance, coupled with the economic benefits to industry
within their inventory control system, are both important benefits of
this technology no matter what distribution model is used.

18\. Should all products be considered at high risk of being
counterfeited? how can products at high risk of being counterfeited be
identified? Which, if any of the following criteria should be
considered:

\(a\) potential impact on public health if the product were
counterfeited;

\(b\) any history of, or the potential for, counterfeiting, tampering or
diversion of

the product

\(c\) wholesale and retail price of the product;

\(d\) volume of product sold, both on unit and dollar basis

\(e\) dosage form of the product

\(f\) approved and unapproved uses of the product

\(g\) current and potential misuse or abuse of the product (ie street
value)

\(h\) other products in the class with a history of being counterfeited

\(i\) length of remaining patent life for the product?

Today, consumer products groups are utilizing RFID technology on pallets
of goods, on expensive designer goods, where the price of the technology
components is small in relationship to the value of the goods or
collection of goods. As prices for tags, and infrastructure components
like readers come down, these track and trace technologies will be more
applicable across the broader spectrum and packaging of products.

19\. Discuss what should be included in an FDA guidance on the use of
anti counterfeiting technologies.

The FDA should guide industry to utilize open, standards-based
technologies, which can integrate with best of breed enterprise
applications. The FDA should work with industry and technology partners
to validate technologies, like the SunONE based solution, for use in
real-world models and scenarios.

20\. Should FDA conduct research on development or evaluation of anti
counterfeiting technologies? if so, what should this research focus on?
how should FDA integrate its research efforts with other public and
private sector efforts?

Sun suggests that the FDA utilize a cooperative research and development
arrangement with industry and technology partner like Sun to evaluate or
pilot track and trace technologies like RFID. Sun has also offered its
iForce Solution Centers to the FDA and industry to test new technologies
and build applications.

21\. Discuss what could be included in an FDA guidance on physical site
security and supply chain integrity.

Security is a key concern for deployment of any system which collects
and utilizes data that is critical to patient or consumer safety such as
the unique identification of pharmaceutical products. Sun recommends
that the FDA ensure that these track and trace technology solutions be
built on infrastructures which can provide for security based on user,
group, or role-based access in order to ensure that this data is not
compromised.

**Conclusion**

**Sun is pleased to provide input on our Auto-ID infrastructure as well
as suggestions as to how the FDA could take advantage of Sun resources
like the iForce Centers to pilot or test RFID technologies in the battle
against counterfeit drugs. Sun welcomes the opportunity to work with the
FDA and industry in this important initiative.**