[Federal Register Volume 72, Number 62 (Monday, April 2, 2007)]
[Notices]
[Pages 15701-15703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1604]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0114]
Electronic Distribution of Prescribing Information for
Prescription Drug Products; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing to solicit views and information from interested parties
concerning the concept of electronic distribution of FDA-approved
prescribing information currently contained in the package insert (or
PIs) for human prescription drug and biological products. In
particular, FDA is seeking views and information on the feasibility of
establishing a modern and efficient process for industry to
electronically distribute prescribing information to dispensers. We are
seeking input on a number of questions regarding the current use of
package inserts and those logistical issues associated with electronic
distribution of such prescribing information.
DATES: Public Hearing: The public hearing will be held on April 27,
2007, from 9 a.m. to 5 p.m. However, depending on the level of public
participation, the public hearing may be extended later or may end
early. If you need special accommodations due to a disability, please
contact Erik Mettler (see FOR FURTHER INFORMATION CONTACT) by April 20,
2007.
Registration: Seating at the public hearing is limited.
Registration is free and will be on a first-come, first-serve basis.
Persons interested in attending the public hearing should register by
close of business on April 20, 2007.
Notice of Oral Presentation: Persons interested in presenting
responses to the questions should submit a notice of oral presentation
by close of business on April 17, 2007. See section I of this document
for information on how to participate in the public hearing.
Comments: Submit written or electronic comments by June 22, 2007.
ADDRESSES: Public Hearing: The public hearing will be held at 5600
Fishers Lane, third Fl., conference rooms D & E, Rockville, MD 20857.
Registration: Submit written registration to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
registration to http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
Notice of Oral Presentation and Comments: Submit written notices of
oral presentation and comments to the Division of Dockets Management
(see previous paragraph). Submit electronic notices of oral
presentation and comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Identify all submissions to the
docket with the docket number found in
[[Page 15702]]
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360, [email protected].
SUPPLEMENTARY INFORMATION:
I. How to Participate in the Public Hearing
The procedures governing the hearing are set forth in part 15 (21
CFR part 15) of FDA's regulations. If you wish to make an oral
presentation during the hearing, you must submit a written notice of
oral presentation with the Division of Dockets Management (see
ADDRESSES) by April 13, 2007. In the written notice, submit your name,
title, business affiliation, address, telephone number, fax number, and
e-mail address. You should also submit a written statement for each
discussion topic in section IV of this document that you intend to
address, or other pertinent information related to the topic in your
presentation, the names and addresses of all individuals that plan to
participate, and the approximate time requested for your presentation.
We encourage individuals and organizations with common interests to
consolidate or coordinate their presentations to allow adequate time
for each request for presentation. Participants should submit to the
docket a copy of each presentation.
We will file the hearing schedule indicating the order of
presentation and the time allotted to each person with the Division of
Dockets Management (see ADDRESSES). We will also mail or telephone the
schedule to each participant before the hearing. In anticipation of the
hearing presentations moving ahead of schedule, participants are
encouraged to arrive early to ensure their designated order of
presentation. Participants who are not present when called, risk
forfeiting their scheduled time.
II. Background
The PIs with prescribing information accompany prescription drugs
to meet the requirement that ``labeling on or within the package from
which the drug is to be dispensed bears adequate information for its
use * * * .'' (21 CFR 201.100(c)(1). FDA approves the prescribing
information as part of the drug's labeling in the drug application.
Currently, the PI containing the prescribing information for the safe
and effective use of the product is a paper leaflet. PIs are used in
numerous ways by various healthcare entities, including pharmacies that
receive and dispense the drug, and provide important drug information
for the safe and effective use of the product. Such information
includes, among other things, indications, adverse events, warnings and
precautions, and dosing instructions. Although the information in the
PI is a valuable resource, it is often not readily accessible when a
healthcare provider who has not physically received the drug makes a
treatment decision or discusses treatments with a patient.
Additionally, the PI may not contain the most current information,
because the PI accompanying the drug's distribution may have been
printed and distributed prior to more recent labeling changes. As the
healthcare system advances into the 21st century, we are considering
how dissemination of the prescribing information contained in the PI
can take advantage of technological advances in the electronic
transmission of information.
III. Purpose and Scope of the Hearing
The purpose of the public hearing is to gain a better understanding
of how the prescribing information in a PI is currently used by
healthcare entities and what the information needs are as we consider
new approaches to disseminating labeling information. We are also
interested in getting a better understanding of the logistical
processes that are currently in place or that might need to be
established in order to electronically disseminate the prescribing
information, including the costs of these efforts.
In particular, we would like to hear from manufacturers of drug and
biological products, pharmacists and pharmacies, other healthcare
providers, wholesalers, consumers, and information providers.
IV. Issues for Discussion
To help achieve the objectives discussed in section III of this
document, we are specifically interested in hearing comments on the
following questions and any other pertinent information related to the
electronic distribution of the prescribing information.
A. General
(1) Currently, who uses, and benefits from the prescribing
information?
(2) How can electronic distribution and access of the prescribing
information be accomplished?
(3) Would electronic distribution and access of the prescribing
information improve the public health?
(4) Would electronic distribution and access of prescribing
information improve prescribing habits? If so, how?
(5) How might we ensure that changes in the distribution and access
of the prescribing information will not negatively affect the current
users?
(6) Would an increase in electronic access to prescribing
information affect prescribers, pharmacists, and patients? If so, how?
B. Logistics
(1) Generally and without focusing on vendor-specific methods, how
can electronic distribution of prescribing information be accomplished?
(2) What are the costs associated with the successful
implementation of electronic distribution and access to prescribing
information, including start-up and maintenance expenses? Please
breakdown costs per healthcare sector.
(3) Is the technology and infrastructure currently available to
accomplish electronic distribution and access? If so, what is
available? If not, what is needed?
(4) What are other potential barriers to accomplishing the
electronic prescribing information?
(5) How can we ensure that electronic prescribing information is
accessible to those who need the information?
(6) How do we meet the needs of those who do not have electronic
capability?
(7) In case of emergency or when a computer system is down, what
might be the backup?
(8) How should electronically disseminated prescribing information
be regularly updated and remain current?
(9) What are the roles for the involved parties (manufacturers,
third-parties, health professionals, FDA, and consumers)?
(10) Should all products have electronic prescribing information or
are there some products or classes of products that should continue to
have a paper prescribing information accompany the product?
(11) If electronic prescribing information were to be used instead
of paper inserts, then how should electronic prescribing information be
implemented? Should electronic prescribing information be phased in? If
so, over what time period? Which products should use electronic
prescribing information first?
V. Notice of Hearing Under Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15. The hearing will be
conducted by a presiding officer, who will be
[[Page 15703]]
accompanied by FDA senior management from the Office of the
Commissioner, the Office of Policy and Planning, the Office of the
Chief Counsel, the Center for Drug Evaluation and Research, and the
Center for Biologics Evaluation and Research.
Persons who wish to participate in the part 15 hearing must file a
written or electronic notice of oral presentation with the Division of
Dockets Management (see ADDRESSES and DATES). To ensure timely handling
of written submissions, any outer envelope should be clearly marked
with the docket number found in brackets in the heading of this
document, along with the statement ``Electronic Distribution of Package
Inserts for Prescription Drug Products.'' Requests to make an oral
presentation should contain the potential presenter's name and title;
address; telephone and fax number; e-mail address; affiliation, if any;
the sponsor of the presentation (e.g., the organization paying travel
expenses or fees), if any; and a brief summary of the presentation
(including the discussion topic(s) that will be addressed).
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants.
To the extent that the conditions for the hearing, as described in
this document, conflict with any provisions set out in part 15, this
document acts as a waiver of those provisions as specified in Sec.
15.30(h).
VI. Requests for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic notices of oral presentation and
comments for consideration. To permit time for all interested persons
to submit data, information, or views on this subject, the
administrative record of the hearing will remain open until June 22,
2007. Persons who wish to provide additional materials for
consideration should file these materials with the Division of Dockets
Management (see ADDRESSES). You should annotate and organize your
comments to identify the specific questions identified by topic to
which they refer (see section IV of this document). Two paper copies of
any mailed comments are to be submitted, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number at the heading of this document. Received comments may be seen
in Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday.
VII. Transcripts
The hearing will be transcribed as stipulated in Sec. 15.30(b).
Transcripts of the hearing will be available for review at the Division
of Dockets Management (see ADDRESSES) and on the Internet at http://www.fda.gov/ohrms/dockets approximately 21 days after the hearing. You
may place orders for copies of the transcript through the Freedom of
Information Office (HFI-35), Food and Drug Administration, 5600 Fishers
lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents per page.
Dated: March 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1604 Filed 3-28-07; 1:02 pm]
BILLING CODE 4160-01-S