[Federal Register: January 11, 2006 (Volume 71, Number 7)]
[Notices]
[Page 1759-1763]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja06-43]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: poppy.kendall@fda.gov.
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: Isabelle_Howes@grad.usda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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:
Isabelle_Howes@grad.usda.gov.
[[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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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