[Federal Register Volume 71, Number 7 (Wednesday, January 11, 2006)]
[Notices]
[Pages 1759-1763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 2005N-0510]


Anti-Counterfeit Drug Initiative Workshop and Vendor Display

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop and vendor display.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop and vendor display on the use of electronic track and trace 
technology to combat counterfeit drugs. The purpose of the meeting is 
as follows: To identify incentives for widespread adoption of radio-
frequency identification (RFID), as well as obstacles to the adoption 
of RFID across the U.S. drug supply chain and possible solutions to 
those obstacles; to solicit comment on the implementation of the 
pedigree requirements of the Prescription Drug Marketing Act (PDMA) and 
the use of an electronic pedigree (e-pedigree); and to learn the state 
of technology development related to electronic track and trace and e-
pedigree technology solutions.
    To address these issues, we are inviting interested individuals, 
organizations, and other stakeholders to present information to FDA's 
Counterfeit Drug Task Force. We are also inviting vendors of track and 
trace technologies and e-pedigree solutions relevant to the drug 
distribution system to display their products for the educational 
benefit of FDA and attendees. (For this meeting, we are only interested 
in displays from vendors of track and trace technology and e-pedigree 
solutions for the PDMA requirement, as opposed to covert or overt 
counterfeiting technologies, such as holograms or color-shifting inks.)

DATES AND TIMES: The public workshop and vendor display will be held on 
February 8 and 9, 2006, from 9 a.m. to 5 p.m. See section V of this 
document for information on how to register to attend, present at the 
workshop, or participate in the vendor display. If you would like to 
present at the workshop or participate in the vendor display, you must 
register by January 27, 2006.
    We are opening a docket to receive your written or electronic 
comments. Written or electronic comments must be submitted to the 
docket at the address below by February 24, 2006.

ADDRESSES: The public workshop and vendor display will be held at 
Holiday Inn Select Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814.
    Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Submit written comments to Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. All comments should be identified with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For information about this document: Poppy Kendall, Food and Drug 
Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, FAX: 301-594-6777, e-mail: [email protected].
    For information about registration or if you need special 
accommodations due to a disability: Isabelle Howes, Graduate School, 
U.S. Department of Agriculture, 490 L'Enfant Plaza, Promenade Level, 
suite 710, Washington, DC 20024, 202-314-4713, FAX: 202-479-6801, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding a Public Workshop and Vendor Display?

    On February 18, 2004, we issued a report entitled ``Combating 
Counterfeit Drugs: A Report of the Food and Drug Administration'' 
(Counterfeit Drug Report) (http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html). This comprehensive report highlights 
several measures that can be taken to better protect Americans from 
counterfeit drugs. These measures address a range of critical areas:
     Securing the actual drug product, its packaging, and the 
movement of the product as it travels through the U.S. drug 
distribution chain;
     Enhancing regulatory oversight and enforcement;
     Increasing penalties for counterfeiters;
     Heightening vigilance and awareness of counterfeit drugs; 
and
     Increasing international collaboration.
    We issued an update to the Counterfeit Drug Report in May 2005. 
(See http://www.fda.gov/oc/initiatives/counterfeit/update2005.html).
    We have worked with manufacturers, wholesalers, pharmacies, 
consumer groups, technology specialists, standard-setting bodies, State 
and Federal agencies, international governmental entities, and others 
to advance the measures outlined in the Counterfeit Drug Report.
    In the Counterfeit Drug Report, we stated that adoption and 
widespread use of reliable track and trace technology is feasible by 
2007. We stated that, if properly implemented, this technology would 
help secure the integrity of the supply chain by providing an accurate 
drug ``pedigree,'' an electronic record (also known as an ``e-
pedigree'') documenting the distribution of the drug from the point of 
manufacture to the final dispenser. We particularly supported the 
implementation of electronic track and trace mechanisms and noted that 
RFID is the most promising technology to meet this need. RFID 
technology involves tagging the drug product package with a tiny radio 
frequency chip containing essential data in the form of an electronic 
product code (EPC) or unique electronic serial number. If implemented 
properly, RFID could allow supply chain stakeholders to track the chain 
of custody (or pedigree) of every package of medication through every 
step of the supply chain. A unique electronic serial number could also 
be embedded in some types of barcodes.
    As discussed further in this document, we have delayed the 
effective date of certain regulations related to the PDMA until 
December 1, 2006. We delayed the effective date in 2004 in order to 
give stakeholders in the drug supply chain time to focus on 
implementing widespread use of e-pedigree across the drug supply chain

[[Page 1760]]

and to consider the effects of adoption of electronic track and trace 
technology on certain PDMA requirements. We are also soliciting comment 
on issues related to the delayed effective date, as discussed more in 
section III of this document.
    Progress has been made towards adoption of RFID and implementation 
of an e-pedigree across the U.S. drug supply chain, although more 
slowly than originally anticipated. Several issues have surfaced that, 
left unresolved, may slow or impede the adoption of RFID. These issues 
merit a public discussion as RFID standards are being developed and 
greater experience with RFID is gained. Therefore, we have reconvened 
FDA's Counterfeit Drug Task Force, which decided to hold this public 
workshop to address these and other related issues. This public 
workshop will focus on securing the product and its movement through 
the supply chain.
    This workshop and vendor display have the following three 
objectives:
     Identify incentives for widespread adoption of RFID, as 
well as obstacles to the adoption of RFID across the U.S. drug supply 
chain and possible solutions to those obstacles;
     Solicit comment on the implementation of the pedigree 
requirements of the PDMA and the use of an e-pedigree; and
     Learn the state of technology development related to 
electronic track and trace and e-pedigree technology solutions.
    After taking into account public comment provided at the meeting or 
submitted to the docket, the Task Force may develop and issue 
recommendations.

II. What Issues Are We Interested in Seeking Comment on at the Meeting 
Related to RFID and E-pedigree?

    Please fully explain your rationale and reasons for your answers 
and comments to the following questions.

A. Implementation of RFID

    1. What incentives are needed for more rapid and widespread 
adoption of RFID in the U.S. drug supply chain? How can these 
incentives be achieved?
    2. What are the current obstacles to widespread adoption of RFID in 
the U.S. drug supply chain? How can these obstacles be overcome?
    3. What is FDA's role in further facilitating adoption of RFID 
across the drug supply chain?
    4. What is the timetable for widespread adoption of RFID across the 
drug supply chain, with and without additional incentives?

B. RFID Standard Setting

    1. Who should set the standards for RFID? Currently we are aware of 
the efforts of only one organization, EPCglobal, to develop standards 
for the use of RFID in the drug supply chain. Are there other entities 
within the United States or abroad that are also developing standards 
for the use of RFID for the drug supply chain?
2. Role of FDA
     Is there a role for Federal leadership by FDA to advance 
the standard setting efforts? What is that role? Is there a role for 
other Federal entities, such as the Drug Enforcement Administration or 
the Department of Defense?
     Should standards remain voluntary? Why?

C. Specific Drug Supply Chain RFID and E-pedigree Issues

    We have been approached by a number of stakeholders for our advice 
and thoughts on various issues that have surfaced as a result of RFID 
pilot studies, standards development, and e-pedigree implementation. We 
would like to discuss these issues at the public workshop.
1. Mass Serialization
    In the Counterfeit Drug Report, we advocated the use of mass 
serialization, which involves the incorporation of unique identifier 
numbers on each drug package in order to track the individual drug 
package as it moves through the supply chain. We still believe that 
this is an important element for the success of electronic track and 
trace in the drug supply chain.
     What numbering conventions currently are being used or 
considered for mass serialization?
     Should there be a single numbering convention or are 
different conventions compatible?
     Should the national drug code (NDC) be part of the unique 
identifier or should the identifier be a randomly generated number? 
Concerns have been raised that use of the NDC raises privacy issues. 
What is the extent of these concerns and how should they be addressed?
     What is the timetable for widespread mass serialization 
for prescription drug products, with and without additional incentives?
2. Universal Pedigree Fields
    FDA regulations at 21 CFR 203.50 (currently stayed) list the 
information that must be provided in the pedigree. This is the minimum 
information that was also set forth in the PDMA. These requirements 
were established at a time when a paper pedigree was the only mechanism 
available for passing a pedigree. An e-pedigree not only requires 
additional information because of its technological nature, but it may 
also facilitate the inclusion of more information. In addition, some 
States are requiring that specific information be included in pedigrees 
passed with drugs sold in their State. Consequently, pedigree 
information required by one State may be different than the pedigree 
information required in the next State where the drug is received. Some 
States now also require that all wholesalers (both primary and 
secondary) pass pedigrees.
     Are there logistical concerns or barriers to passing a 
pedigree for a drug that moves from one State to another with different 
pedigree requirements?
     Would a universal pedigree alleviate these concerns or 
barriers? How?
     What common fields/information are the most important in a 
pedigree? Why?
     How can a universal pedigree be achieved?
3. Data Management and Security
    For e-pedigree transmission from manufacturer to dispenser to be 
successful, business partners must be able to share information 
specific for the product that is the subject of the pedigree. We are 
aware that there is a great deal of interest in the management and 
sharing of pedigree information among business partners.
     One issue that has been raised is whether the data/
information should be stored in one central database or if a 
distributed approach (where each stakeholder's system exchanges 
information with other systems) should be used. Can/should the pedigree 
information be passed and authenticated using either model? If some 
stakeholders subscribe to a central database and others use a 
distributed approach, can the pedigree information still be passed and 
authenticated?
     If there is to be a central database, who should host it? 
Why?
     What types of encryption or other data security measures 
are available to ensure the authenticity of the information being 
passed and digitally signed?
     What measures can be taken to secure the databases 
themselves in either the central database or distributed approach?

D. Privacy Issues

    The use of RFID in the drug supply chain raises a number of privacy 
issues. It is important to fully understand the

[[Page 1761]]

issues and ensure that measures are in place to protect patient 
privacy. We have also heard concerns that thieves or others could 
unscrupulously identify a drug product if its identity is concealed.
1. Disclosure of Information
    Is it possible for someone to read the information from an RFID tag 
on a drug product without the possessor of the product knowing it? If 
it is possible, what information would they learn, and how could the 
information be used?
2. Turning off the RFID Tag
    Some people have suggested that the RFID tag could be ``turned 
off'' before it leaves the pharmacy, or that patients could be given 
the choice of whether it is ``turned off.'' Is it possible to ``turn 
off'' the RFID tag? What are the advantages or disadvantages of 
``turning off'' the RFID tag?
3. Consumer Education
    What type of consumer education is needed as the use of RFID in the 
drug supply chain becomes more prevalent? What messages should be 
conveyed? Who should develop consumer education program(s)? Should 
there be a notice on the product package that an RFID tag is affixed to 
the product package? If so, what should the notice say?

E. Public Health Emergency Use

    In certain public health emergency situations, it is essential to 
promptly and efficiently deploy vital medications from Federal or State 
stockpiles to locations that need them the most, as well as rapidly 
identify and reroute vital medications from other sources when there is 
a national shortage. Such situations could include anti-viral drugs for 
pandemic influenza, countermeasures for bioterrorist incidents, or 
antibiotics or other essential medications for natural disasters, such 
as hurricanes. Electronic track and trace technology, such as RFID, 
could enable public health officials to know what medications are 
available to meet their needs from the closest stockpile, how much is 
available, track its location en route to the site, as well as provide 
a means for inventory control onsite.
    In addition, in times of crisis, we can anticipate an increase in 
devious and unscrupulous activities, such as drug counterfeiting and 
diversion of medicines that are in high demand for the public health 
situation at hand.
    1. How can RFID be utilized in these types of public health 
emergencies, such as pandemic influenza? Should RFID be used on other 
types of medical countermeasures besides drugs in the Strategic 
National Stockpile?
    2. What is the role of the Federal Government in encouraging or 
requiring RFID or other electronic track and trace technologies for 
drugs most likely used in these situations?
    3. Are companies willing to explore the use of RFID for drugs most 
likely to be used in these situations?

F. Other

    Are there other issues that need to be addressed to facilitate the 
widespread adoption of RFID across the U.S. drug supply chain?

III. What Issues Are We Interested in Discussing related to PDMA and E-
pedigree?

    The PDMA of 1987 (Public Law 100-93), as modified by the 
Prescription Drug Amendments of 1992 (PDA) (Public Law 102-353, Stat. 
941), amended sections 301, 303, 503, and 801 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, 381) to, 
among other things, establish requirements for the wholesale 
distribution of prescription drugs. Section 503(e)(1)(A) of the act (21 
U.S.C. 353(e)(1)(A)) requires that ``each person who is engaged in the 
wholesale distribution of a drug * * * who is not the manufacturer or 
authorized distributor of record of such drug * * * provide to the 
person who receives the drug a statement (in such form and containing 
such information as the Secretary may require) identifying each prior 
sale, purchase, or trade of such drug (including the date of the 
transaction and the names and addresses of all parties to the 
transaction.)'' This is the so-called ``pedigree'' requirement. The 
PDMA states that an authorized distributor of record is a wholesaler 
that has an ``ongoing relationship'' with a manufacturer to distribute 
that manufacturer's drug; however, it does not define ``ongoing 
relationship.'' (21 U.S.C. 353(e)(3)(A)).
    In the Federal Register of December 3, 1999 (64 FR 67720), the 
agency published final regulations (the 1999 final rule) in part 203 
(21 CFR part 203) implementing PDMA that were to take effect on 
December 4, 2000. After publication of the 1999 final rule, the agency 
received comments from industry, industry trade associations, and 
members of Congress objecting to the provisions in Sec. Sec.  203.3(u) 
and 203.50. These provisions define the phrase ``ongoing relationship'' 
as used in the definition of ``authorized distributor of record'' and 
set forth requirements regarding an identifying statement of origin 
(commonly referred to as a ``pedigree'').
    Based on the concerns raised, the agency delayed the effective date 
for those provisions until October 1, 2001, (65 FR 25639) to reopen the 
comment period for the regulations and receive additional comments. In 
addition, the House Committee on Appropriations requested that the 
agency review the potential impact that the regulation would have on 
the secondary wholesale pharmaceutical industry and prepare a report 
summarizing the comments and issues raised and the agency's plans to 
address these concerns.
    The agency's report, which was submitted to Congress on June 7, 
2001, concluded that we could address some of the concerns raised by 
the secondary wholesale industry through regulatory changes. However, 
to make some of the changes requested by the secondary wholesale 
industry, Congress would have to amend relevant provisions of section 
503(e) of the act (see http://www.fda.gov/oc/pdma/report2001/). Since 
submitting the report to Congress, we have continued to delay the 
effective date of these provisions.
    Most recently, on February 23, 2004 (69 FR 8105) (as amended on 
March 18, 2004 (69 FR 12792)), we further delayed the effective date of 
these particular provisions until December 1, 2006, because we were 
informed by stakeholders in the U.S. drug supply chain that industry 
would implement electronic track and trace capability by 2007. When 
widely adopted, this capability would create a de facto electronic 
pedigree that would follow the product from the place of manufacture 
through the U.S. drug supply chain to the final dispenser. If properly 
implemented, electronic pedigree could meet the statutory requirement 
in section 503(e) of the act.
    The agency has been closely monitoring the implementation of 
electronic track and trace and electronic pedigree across the U.S. drug 
supply chain. As the expiration of the December 1, 2006, delayed 
effective date gets closer, it appears that the goals described 
previously may not be met. To guide the agency's decision whether to 
continue the delayed effective date, let the regulatory provisions go 
into effect, or take other steps, we are particularly interested in 
testimony and comments on the following issues:
    Please fully explain your rationale and reasons for your answers 
and comments to the following questions.

[[Page 1762]]

A. 1999 Final Rule

1. Small Business Impact
    At FDA's 2001 PDMA public meeting, we heard testimony and received 
comments that the 1999 final rule provisions at issue would have a 
significant impact on small businesses because these businesses would 
not be able to obtain the necessary information to adequately complete 
pedigrees and sell drug products. Since 2001, there have been a number 
of process changes in the way that wholesalers do business, such as 
increased use of computers and barcodes, electronic track and trace 
solutions, and new state wholesaler laws, which could alleviate some of 
the earlier concerns. How has the potential impact of the 1999 rule on 
small businesses changed since the 2001 public meeting?
2. Delay of The Effective Date
     If the delay of the effective date is not extended, how 
will implementation of the rule affect primary and secondary 
wholesalers? Would it impact the distribution of drugs to smaller 
retail outlets or rural communities? Will secondary wholesalers have 
access to the information they need to meet the pedigree requirements?
     What is the regulatory significance of the fact that the 
current federal pedigree requirements apply only to wholesalers who are 
not authorized distributors of record? Please explain.
     Should the delay of the effective date be further 
extended? If so, how long should it be extended? Why?
     If the delay of the effective date is not extended, would 
the 1999 rule ensure that there is effective track and trace capability 
to combat drug counterfeiting? If not, why? In order to further address 
this question, we refer you to the 2001 Report to Congress at
http://www.fda.gov/oc/pdma/report2001/.
3. Minimum Standards for Wholesaler Licensing
     The PDMA required FDA to issue minimum standards for 
wholesaler licensing. ((21 USC 353(e)(s)(A)), codified at (21 CFR 
205.3)). These standards were adopted by the states and incorporated 
into state law. How effective are these standards?
4. State Efforts
     How would the recent actions by various states that have 
implemented stricter wholesale licensing and oversight laws impact 
compliance with the 1999 final rule?

B. Adoption of E-pedigree Across the Drug Supply Chain

    1. What is the status of developing standards that allow for 
interoperability of e-pedigree solutions across the drug supply chain?
    2. To what extent are stakeholders using e-pedigree?
    3. If you are not using an e-pedigree program now, do you 
anticipate having this capability in the future? If so, when do you 
plan to use e-pedigree?
    4. What is the experience to date of interoperable e-pedigree 
solutions across the drug supply chain?
    5. Paper to E-pedigree Transition
     Discuss the feasibility of a paper and e-pedigree system 
co-existing across the drug supply chain.
     Can the authenticity and validity of the pedigree be 
maintained in such a system? How can this be done?
     What capabilities would be needed for such a system?
     Please provide cost estimates for the minimal equipment 
and infrastructure needed for members of the supply chain to accept and 
pass a paper pedigree? Cost estimates for use of e-pedigree? Is there a 
difference in costs if the drug product has a unique identifier versus 
one that does not?
    6. What is the timetable for widespread adoption of e-pedigree 
across the drug supply chain, with and without additional incentives?

IV. Technologies That Will Be Considered For Display At the Vendor 
Display

    One purpose of this meeting is to gain greater understanding about 
electronic track and trace technology and e-pedigree. Therefore, we are 
inviting manufacturers and organizations that market or have in 
development an electronic track and trace product to display their 
product at this meeting. We are also inviting manufacturers and 
organizations that market, have in development, or are facilitating e-
pedigree solutions across the U.S. drug supply chain to display their 
products. Although very important in the effort to combat counterfeit 
drugs, it is beyond the scope of this program to display overt and 
covert products and technologies used for anti-counterfeiting 
including, but not limited to, holograms, color-shifting inks, 
taggants, and nanotechnologies.
    Questions about whether your product or technology would fall 
within the scope of this vendor display should be directed to the 
contact person for vendor displays listed at the top of this notice.

V. How Do You Register?

    Registration is required if you would like to present at the 
workshop or participate in the vendor display. If you wish only to 
attend the workshop and vendor display, you should also register 
because space is limited.
    Because of time constraints, you may register either to present at 
the workshop or participate in the vendor display. You may not register 
for both. If you choose to participate in the vendor display, you will 
have the opportunity to share information about your products with the 
FDA Task Force members through your participation in the vendor 
display.
    You may register online to present at the workshop or participate 
in the vendor display at http://www.fda.gov/RFIDmeeting.html no later 
than January 27, 2006. The online registration form will instruct you 
as to the information you should provide (such as name, address, 
telephone number, e-mail address, whether you wish to make a 
presentation or participate in the vendor display, summary of your 
presentation or product). To register to attend the workshop, go to 
this same Web site. Seating is limited to 400 persons and if capacity 
is reached, registration will close. If you register as a presenter or 
to participate in the vendor display, you do not need to also register 
as an attendee.
    If you plan to present at the workshop, we will try to accommodate 
all persons who wish to make a presentation. We encourage persons and 
groups having similar interests to consolidate their information and 
present it through a single representative, if possible, to enable a 
broad range of views to be presented.
    By February 2, 2006, we will schedule each appearance and, by e-
mail or telephone, notify each participant who will present of the time 
allotted to the person and the approximate time the person's 
presentation is scheduled to begin. The time allotted for presentations 
may be between 5 to 15 minutes, depending on the number of people who 
wish to present.
    At the time of registration, you will be asked to provide a short 
summary of your presentation. Presenters must send final electronic 
presentations in Microsoft PowerPoint, Microsoft Word, or PDF by 12 
noon on February 6, 2006, to Isabelle Howes, Graduate School, U.S. 
Department of Agriculture, 490 L'Enfant Plaza, Promenade Level, suite 
710, Washington, DC 20024, 202-314-4713, e-mail: [email protected].

[[Page 1763]]

    If you plan to participate in the vendor display, there will be no 
fee for participating in the vendor display. For the purposes of this 
meeting, we are only interested in displays from vendors of track and 
trace technologies and e-pedigree solutions. At the time of 
registration, you will be asked to submit a short summary of your 
product.
    We can accommodate 30 vendors at this meeting. When vendor 
registration reaches this number, additional vendor display registrants 
will be placed on a wait-list. If you have been placed on the wait-
list, we will notify you by e-mail or telephone if you become 
confirmed. There will be no onsite registration for vendors. Each 
vendor will be provided with a 6-foot tabletop space. Please note that 
Internet access will not be available.

VI. How Should You Send Comments on the Issues?

    If you would like to submit comments on any of the issues described 
in this document, please send your comments to the Division of Dockets 
Management (see ADDRESSES). Submit a single copy of electronic comments 
or two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments should be identified with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday. To ensure consideration of your 
comments, we must receive any written or electronic comments by the 
date indicated (see DATES AND TIMES).

VII. Will Meeting Transcripts Be Available?

    The workshop will be transcribed. The transcript will be posted on 
FDA's Web site at www.fda.gov. You may request a copy of the transcript 
by writing to our Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857. We 
anticipate that transcripts will be available approximately 10 days 
after the public meeting at a cost of 10 cents per page. The 
transcripts will also be available for public examination at the 
Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 5, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-249 Filed 1-9-06; 8:45 am]
BILLING CODE 4160-01-S