[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

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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