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November 3, 2003

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket 2003N-0361

Submitted electronically to
<http://frwebgate.access.gpo.gov/cgi-bin/leaving>.

Attention: Anti-Counterfeit Drug Task Force

Thank you for the opportunity to present and demonstrate track and trace
technology, RFID, and anti-counterfeit technology at your public meeting
held on October 15, 2003. Zebra has considerable experience in bar code
printing and systems, has been a leader in the development of standards
for the blood bagging industry, and has implemented secure systems for
the Department of Defense. Our over thirty years of experience in bar
code technology and leadership in the pharmaceutical industry make us
uniquely qualified to comment on some of the important issues
surrounding the drug supply chain today.

Attached is Zebra Technologies' submission of comments to docket
2003N-0361. The first attachment, *Comments to FDA 10/15/03*, are the
final comments presented to the FDA on 10/15/03. Below, we have also
answered questions in the federal register (Federal Register: September
5, 2003 (Volume 68, Number 172, Notices, Pages 52772-52775) that we felt
were most relevant to our area of expertise. Finally, we have also
attached two whitepapers developed by Zebra---one that details the
benefit of bar coding within the pharmaceutical supply chain and one
that details secure media solutions.

We would welcome the opportunity to speak with you directly about any of
the matters presented.

Respectfully,

Deborah H. Murphy

Life Sciences Market Development Manager

James O'Hagan

Director, Technology Transfer

**A: Technology**

> 1\. Secure operational methods that make it more difficult for
> criminals to obtain access to genuine drugs and genuine packaging,
> more difficult to replace those drugs with convincing counterfeits,
> and more difficult to divert drugs into inappropriate channels are key
> to the success of any anti-counterfeit measures. Technology can play a
> valuable role in helping detect when the supply chain has been
> compromised. It can also play an important role in quickly gathering
> information that is critical to our ability to limit the detrimental
> effects of the bogus medications and to prosecute criminals. Some
> technologies can also make it more difficult for criminals to produce
> convincing counterfeit packaging.

Both track and trace technologies and authentication technologies should
be used in fighting counterfeit drugs. Track and trace technologies are
most useful for quickly identifying the extent to which the supply chain
has been compromised by counterfeiters or diverters. Track and trace
technologies have the added benefits of streamlining supply chain
operations, thus reducing handling costs and reducing the amount of
outdated medication within the supply chain.

> This level of specificity requires a consistent, widely used, and
> easily automated taxonomy for both medications and suppliers. The 14
> digit Global Trade Identification Number maintained by UCC.EAN is an
> excellent platform on which to build a communication system for
> medications because it is specific, consistent, widely used, and
> easily automated. Similar EAN.UCC keys exist for tracking individual
> shipments. In addition, the FDA should endorse the creation of a
> similar, authenticable identity for use by manufacturers, pharmacists,
> and supply chain partners. This could be extended by the industry to
> develop secure operational practices as well as procedures, including
> communications that would occur when those practices are compromised.

[Track and Trace Technologies]{.underline}

Track and trace technologies span a wide range of operational methods
and technologies, including:

+------------+-----------------+------------------+------------------+
| **Te       | **Overview**    | **Benefits**     | **Drawbacks**    |
| chnology** |                 |                  |                  |
+------------+-----------------+------------------+------------------+
| **Paper    | Printed piece   | Provides details | Easy to create   |
| manifest** | of paper        | for a shipment   | fraudulent       |
|            | listing each    | that allows the  | documents unless |
|            | handler of a    | tracking of the  | secure paper     |
|            | shipment from   | shipment from    | technologies are |
|            | p               | origin.          | widely used.     |
|            | oint-of-origin. |                  |                  |
|            |                 | Negligible       | Lack of          |
|            |                 | up-front         | centralized data |
|            |                 | investment and   | depository makes |
|            |                 | easy             | it difficult to  |
|            |                 | implementation.  | quickly and      |
|            |                 |                  | accurately       |
|            |                 |                  | identify         |
|            |                 |                  | problems.        |
+------------+-----------------+------------------+------------------+
| **Te       | **Overview**    | **Benefits**     | **Drawbacks**    |
| chnology** |                 |                  |                  |
+------------+-----------------+------------------+------------------+
| **Bar code | Tracking        | Tracking         | Requires         |
| labels**   | information is  | information is   | industry         |
|            | standardized by | encoded into a   | agreement on     |
|            | the industry.   | bar code,        | informational    |
|            |                 | improving        | content and      |
|            | An adhesive     | reading accuracy | format.          |
|            | label carrying  | and improving    |                  |
|            | this            | productivity.    | Adding           |
|            | information is  |                  | authentication   |
|            | created for     | Minimal up-front | requires         |
|            | each individual | investment and   | allowing access  |
|            | shipment and    | on-going         | to centralized   |
|            | permanently     | maintenance      | data.            |
|            | affixed to each | costs. Lowers    |                  |
|            | shipping        | operating costs  |                  |
|            | carton.         | within the       |                  |
|            |                 | supply chain.    |                  |
|            | Access to the   | Wide             |                  |
|            | database for    | availability of  |                  |
|            | the purpose of  | experienced      |                  |
|            | updating the    | integration      |                  |
|            | status of       | partners.        |                  |
|            | product is      |                  |                  |
|            | required.       |                  |                  |
+------------+-----------------+------------------+------------------+
| **         | Identity is     | Identity can be  | Evolving         |
| Electronic | affixed to      | read remotely    | standards,       |
| Product    | packaging as a  | through some     | limited industry |
| Codes**    | low-cost        | types of         | experience,      |
|            | passive RFID    | packaging.       | higher cost than |
|            | tag.            | Relies on        | bar code labels. |
|            | Information on  | integrated data  | State of current |
|            | that package is | throughout the   | technology       |
|            | stored in       | supply chain,    | requires some    |
|            | databases       | which can        | customization    |
|            | accessible by   | provide          | for each type of |
|            | approved        | additional       | product and      |
|            | trading         | supply chain     | related          |
|            | partners.       | benefits.        | packaging.       |
+------------+-----------------+------------------+------------------+
| **Passive  | Identity is     | Allows paper     | Proprietary      |
| Radio      | affixed to      | manifest system  | protocols and    |
| Frequency  | packaging as a  | to be automated  | limited          |
| Identi     | passive         | for improved     | implementation   |
| fication** | rewritable RFID | accuracy,        | expertise        |
|            | tag.            | reduced handling | requires each    |
|            | Information     | costs and quick  | application to   |
|            | regarding each  | access to data.  | be developed as  |
|            | handler is      |                  | a custom         |
|            | written to the  |                  | program.         |
|            | tag as the item |                  | Hardware and     |
|            | moves through   |                  | tags are just    |
|            | the supply      |                  | beginning to     |
|            | chain, allowing |                  | appear on the    |
|            | an auditor to   |                  | market.          |
|            | identify times  |                  |                  |
|            | that a shipment |                  |                  |
|            | may have been   |                  |                  |
|            | compromised.    |                  |                  |
+------------+-----------------+------------------+------------------+
| **Active\  | Similar to      | Currently used   | Proprietary      |
| Radio      | passive RFID,   | by U.S. Customs  | protocols and    |
| Frequency  | but larger tags | for tracking     | limited          |
| Identi     | allow           | international    | implementation   |
| fication** | longer-range    | shipping         | expertise        |
|            | reading and     | containers.      | requires each    |
|            | additional      |                  | application to   |
|            | information     | Provides near    | be developed as  |
|            | storage and     | real-time data,  | a custom         |
|            | functionality,  | encompassing a   | program. Costs   |
|            | such as         | broad range of   | are              |
|            | locating a      | handling         | significantly    |
|            | shipping        | activities.      | higher than      |
|            | container or    |                  | passive RFID.    |
|            | monitoring      |                  |                  |
|            | temperature.    |                  |                  |
+------------+-----------------+------------------+------------------+

Costs for these technologies vary with respect to implementation costs
and tracking costs. Implementation involves agreement on what data will
be shared and how it will flow, creating processes and computer networks
at each trading partner, acquiring and testing hardware, and training
personnel. Tracking costs include on-going software maintenance fees,
media costs (paper, labels, RFID tags), and equipment service and
maintenance. The costs for services and software vary widely, depending
on the sophistication of the network and the chosen solution. Hardware
and media costs also vary widely based on the size and complexity of the
implementing company, but common industry estimates are that 20% of
implementation costs are data acquisition and printing hardware and
annual media costs are four times the cost of the printers. Hardware
estimates include:

+------------+----------------------------+----------------------------+
| **Te       | **Hardware cost**          | **Media Cost**             |
| chnology** |                            |                            |
+------------+----------------------------+----------------------------+
| # Pape     | Standard business printers | 3 cents per page, or 7     |
| r manifest | and copy machines,         | cents per label            |
|            | probably already           |                            |
|            | installed.                 |                            |
+------------+----------------------------+----------------------------+
| **Bar code | Industrial bar code        | 2 to 4 cents per label     |
| labels**   | printers range from \$1000 |                            |
|            | to \$4500 each.            |                            |
+------------+----------------------------+----------------------------+
| **         | Hardware depends on how    | 30 to 50 cents per EPC     |
| Electronic | tag is integrated into     | label                      |
| Product    | packaging. EPC compliant   |                            |
| Codes**    | shipping labels may be     | Individual chips may be    |
|            | printed on an RFID         | under 15 cents in quantity |
|            | printer-encoder ranging    |                            |
|            | from \$3000 to \$8500      |                            |
|            | each.                      |                            |
+------------+----------------------------+----------------------------+
| **Passive  | RFID printer-encoder       | 35 to 75 cents per smart   |
| Radio      | ranging from \$1500 to     | label                      |
| Frequency  | \$8500 each.               |                            |
| Identi     |                            |                            |
| fication** |                            |                            |
+------------+----------------------------+----------------------------+
| **Active   | Hardware costs vary widely | \$3.50 to \$25 per tag and |
| Radio      | on how tags are integrated | up                         |
| Frequency  | with container or          |                            |
| Identi     | packaging.                 |                            |
| fication** |                            |                            |
+------------+----------------------------+----------------------------+

## Anti-counterfeit Technologies

> In addition to track and trace technologies, there are also many
> anti-counterfeit technologies available. These technologies are all
> built on the same premise---allowing easy authentication by trusted
> members of the supply chain, while raising the costs for
> counterfeiters. Typically, multiple layers of authentication are used,
> some for consumers, some for retailers or pharmacists, some for
> trusted enforcement personnel, and some that can only be identified
> and authenticated with proprietary laboratories. This results in the
> most robust system for both quickly identifying suspect medications
> and keeping secure the most proprietary authentication techniques.
>
> Anti-counterfeit technologies serve to:

-   Alter physical characteristics of the medication or its packaging,

-   Digitally encrypt data about the medication or its packaging, then
    store that data in a database or on the item itself in a bar code or
    RFID tag, or

-   Restrict access to the medication or its packaging.

The most secure system will use multiple layers of technology to
integrate all three technology categories. A technology ideally suited
to physically authenticating an individual pill may be cost-prohibitive
if it requires breaking down a pallet of packaged medication to
determine whether or not it includes counterfeit drugs. Restricting
physical access to a shipment may be as simple as a padlock or as
sophisticated as biometric confirmation used as a PIN on a secure
computer network. Clearly there are benefits to layering technologies,
which combine authentication with track and trace capability.

2\. While there have been some efforts by individual pharmaceutical
manufacturers to track shipments and to implement authentication
technologies into medication and packaging, we are unaware of any
industry-wide efforts. Barriers include:

-   A highly regulated industry accustomed to high product margins from
    new product innovations has resulted in slow adoption of supply
    chain tracking technology, compared to lower margin industries
    seeking profitability through lower costs and greater efficiency,
    where we see industry wide adoption,

-   Reluctance to publicly admit susceptibility to counterfeiting and
    diversion,

-   Lack of knowledge by industry leaders regarding the extent of
    counterfeiting, leading to underestimating the probability of being
    negatively impacted by counterfeiting activities,

-   Difficulty in assessing the detailed costs associated with an
    investment in equipment and processes to make counterfeiting more
    difficult,

-   Rapidly changing individual layers of security is a successful
    method for staying ahead of counterfeiters, but this is not
    conducive to industry-wide standards in a highly regulated industry,
    nor is it cost effective.

> 3\. The FDA should play an important role in facilitating the use of
> anti-counterfeit technologies by:

-   Encouraging discussions between drug manufacturers, drug
    distributors, pharmacists, consumer groups, technology providers,
    and government enforcement personnel to disseminate information
    regarding the extent of the counterfeiting problem, understanding
    the associated costs, and evaluating potential solutions.

-   Enabling the creation of a method to provide unique, authenticable,
    and automation-friendly identities to individual manufacturers, drug
    distributors, pharmacists, and their employees. This can then be
    used as a framework for development of an industry-wide standard for
    tracking pharmaceutical shipments.

-   Dedicating some limited amount of FDA resource to streamlined
    approval of new pharmaceutical packaging, allowing drug
    manufacturers or packagers to test new anti-counterfeit
    technologies.

> 4\. Pharmaceuticals, commanding a high market price and in high
> demand, can be inexpensively imitated at low risk of prosecution.
> Potential FDA interventions include:

-   Aggressively promote known counterfeiting cases. This would serve to
    increase the probability of detection, making drug counterfeiting
    less attractive. This would also increase the perceived cost of
    counterfeiting to drug manufacturers and pharmacists, encouraging
    the use of anti-counterfeit technologies.

-   Encourage increased government enforcement efforts and higher
    penalties for counterfeiting medications specifically for those
    medications with higher risk to the patient resulting from not
    taking authentic medications. This would serve to discourage
    counterfeiters from targeting specific high-margin medications
    because the risk of detection would be higher and the associated
    punishment would be more severe.

-   Provide real and perceived benefits to opting in to a secure supply
    chain arrangement similar to the U.S. Customs' Customs Trade
    Partnership Against Terrorism (C-TPAT), thus endorsing industry
    efforts to secure its supply chain and allowing scarce enforcement
    resources to be focused on the small portion of pharmaceutical
    shipments at highest risk to counterfeiting and diversion. This
    could serve to accelerate industry movement toward safe, secure,
    supply chain tracking at lower costs. This raises the cost to
    counterfeiters trying to penetrate the U.S. pharmaceutical supply
    chain, while also lowering the reward to successful counterfeiters.

    **B: Regulatory and Legislative Issues**

    Implementing a more secure supply chain system with an ability to
    track product throughout the supply chain, through multiple trading
    partners, will essentially give the industry an electronic pedigree
    for product. This process would dramatically affect PDMA, and the
    requirements of manufacturers and distributors to comply.

**C: Public Education**

> The usefulness of information disseminated by the FDA, other
> government agencies, and private stakeholders is based largely by how
> targeted it can be to the specific needs of an individual stakeholder.
> A patient on a daily regimen of Lipitor may willingly subscribe to
> e-mail or phone calls alerting him of a specific case of
> counterfeiting that could effect him, while that same patient may be
> unwilling to spend time reading a simple brochure or website on the
> general issue of drug counterfeiting. A busy pharmacist is likely to
> more closely inspect shipments from a specific supplier if she knows
> there has been an immediate threat in that particular area.
>
> This level of specificity requires a consistent, widely used, and
> easily automated taxonomy for both medications and suppliers. The 14
> digit Global Trade Identification Number maintained by UCC.EAN is an
> excellent platform on which to build a communication system for
> medications because it is specific, consistent, widely used, and
> easily automated. Similar EAN.UCC keys exist for tracking individual
> shipments. In addition to these, the FDA should endorse the creation
> of a similar, authenticable identity for use by manufacturers,
> pharmacists, and supply chain partners. This could then be extended by
> the industry to develop secure operational practices as well as
> procedures, including communications that would occur when those
> practices are compromised.

**D. Industry and Health Professional Issues**

> All participants and providers in the healthcare industry have a role
> in preventing and minimizing the damages from counterfeit and diverted
> drugs. The FDA has already created a forum, through the
> Anti-Counterfeit Task Force, for increased exposure to the issues and
> future dialog to address the problems. Manufacturers, wholesalers,
> distributors, repackagers, GPO's, pharmacies, health care providers
> and consumers need to all participate in the creation of a stronger,
> more secure U.S. drug supply. The issues facing us today in
> counterfeiting and diversion can be minimized with technology---and it
> requires the cooperative work of the stakeholders listed above to
> implement a robust solution---through technology, reporting and
> accountability, and public education.