
[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75177-75179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1172]


Impact of Approved Drug Labeling on Chronic Opioid Therapy; 
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 obtain information, particularly scientific evidence, such 
as study data or peer-reviewed analyses, on issues pertaining to the 
use of opioid drugs in the treatment of chronic pain.

DATES: The public hearing will be held on February 7 and 8, 2013, from 
9 a.m. to 4 p.m. Submit electronic or written requests to make oral 
presentations and comments by January 18, 2013. Electronic or written 
comments will be accepted after the hearing until April 8, 2013.

ADDRESSES: The public hearing will be held at the Bethesda Marriott, 
5151 Pooks Hill Rd., Bethesda, MD 20814, 301-897-9400, Fax 1-301-897-
0192.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the 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. Transcripts of the hearing 
will be available for review at the Division of

[[Page 75178]]

Dockets Management and on the Internet at http://www.regulations.gov 
within 30 days of the meeting.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 
20903, 301-796-3416, FAX: 301-847-8752, 
Elizabeth.Giaquinto@fda.hhs.gov; or Mary Gross, Center for Drug 
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 
20903, 301-796-3519, FAX: 301-847-8752, Mary.Gross@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Over the past several years, the role of opioid drugs in treating 
chronic pain has been an increasingly common subject of public 
discussion. FDA and other policymakers have been at the forefront of 
these debates, striving to find a balance between minimizing opioid 
drug abuse and misuse, while simultaneously enabling appropriate access 
to pain-relieving drugs. The July 9, 2012, approval of the Risk 
Evaluation Management Strategy for extended-release (ER) and long-
acting (LA) opioid analgesics is a recent example of FDA's ongoing 
commitment to ensuring that the benefits of these types of opioid drugs 
continue to outweigh their risks.
    While ER/LA opioid issues have been a particular focus of public 
health concern, discussions continue about the proper use of opioid 
drugs in general. Over the past several years, the Agency has received 
comments, petitions, and informal inquiries concerning the extent to 
which opioid drugs should be used in the treatment of pain. In 
particular, members of the public and the regulated community have 
debated the presence or absence of evidence showing the safety and 
efficacy of these drugs as pain relievers in the various populations 
for whom they are prescribed. Many have raised issues specific to 
particular opioids, such as those pertaining to drug product 
composition, specific abuse-deterrence properties, and biological 
action. Some have raised broader issues that impact the entire class of 
opioid drugs or a large subcategory thereof (e.g., ER/LA opioids), such 
as the propriety of controls on drug dosage and duration of 
administration or changes in indication and prescribing practices.

II. Purpose and Scope of the Public Hearing

    In light of the ongoing interest in issues related to opioid use, 
FDA has decided to hold a public hearing to obtain information--
particularly scientific evidence, such as study data or peer-reviewed 
analyses--from expert members of the public on the following questions:

A. Diagnosis and Understanding of Patient Pain

    1. What methods do professionals use to accurately distinguish 
between different types of pain (e.g., cancer vs. non-cancer) and their 
respective etiologies?
    2. What are the definitions of the terms ``mild,'' ``moderate,'' 
and ``severe'' when those terms are used to describe symptomatic 
conditions such as pain?
    3. How do professionals accurately categorize a patient's pain as 
mild, moderate, or severe? For example, what tests or assessments do 
they use?
    4. What methods should and do professionals use to accurately 
distinguish between short-term pain and chronic pain?
    a. What are and should be the time periods that characterize short-
term pain versus chronic pain?
    b. What are and should be considered the clinical differences 
between short-term pain versus chronic pain?
    c. What types of pain, if any, are presumed chronic versus presumed 
short term?

B. Understanding and Adhering to the Labels of Pain-Treating Products

    1. How are the words ``indicated for the treatment of moderate to 
severe pain'' interpreted and used by practitioners when deciding what 
types of treatments (including opioids) are appropriate for treating 
patients with pain?
    2. If the indication for opioid drugs were restricted to the 
treatment of severe pain only, how would such a change impact:
    a. Prescribing practices?
    b. Patient access to pain medication and patient pain control?
    c. Abuse and misuse of opioid medicines?
    3. If the pain threshold described in the indication (e.g., 
moderate, moderate to severe, severe pain) differed based on the pain's 
etiology, how would such an approach impact:
    a. Prescribing practices?
    b. Patient access to pain medication and patient pain control?
    c. Abuse and misuse of opioid medicines?

C. Limiting Opioid Prescription and Use

    1. Limits on exposure to opioid drugs.
    a. What data, if any, exist that would support or oppose the 
establishment of a maximum daily dose for opioid drugs? FDA is 
interested in drug safety or efficacy data in particular.
    b. What data, if any, exist that would support or oppose a 
difference in maximum daily dose for opioid drugs based on pain 
etiology (e.g., cancer vs. non-cancer pain)? FDA is interested in drug 
safety or efficacy data in particular.
    c. What method(s), if any, should be used to establish a maximum 
daily dose of opioid drugs?
    d. What effect(s), if any, would a maximum daily dose for opioid 
drugs have on the following:
    i. Prescribing practices?
    ii. Patient access to pain medication and patient pain control?
    iii. Abuse and misuse of opioid medicines?
    2. Limits on duration of use of opioid drugs.
    a. What data, if any, exist that would support or oppose the 
establishment of a maximum duration of continuous treatment with opioid 
drugs? FDA is interested in drug safety or efficacy data in particular.
    b. What data, if any, exist that would support or oppose a 
difference in maximum duration of continuous treatment with opioid 
drugs based on pain etiology (e.g., cancer vs. non-cancer pain)? FDA is 
interested in drug safety or efficacy data in particular.
    c. What method(s), if any, should be used to establish a maximum 
duration of continuous treatment with opioid drugs?
    d. What effect(s), if any, would a maximum duration of continuous 
treatment with opioid drugs have on the following:
    i. Prescribing practices?
    ii. Patient access to pain medication and patient pain control?
    iii. Abuse and misuse of opioid medicines?

III. Attendance at and/or Participation in the Public Hearing

    If you wish to attend the hearing or make an oral presentation 
during the hearing, you must register by submitting either an 
electronic request (see the Web address listed at the end of this 
paragraph) or written request (see FOR FURTHER INFORMATION CONTACT) by 
close of business on January 18, 2013. You must provide your name, 
title, business affiliation (if applicable), address, and type of 
organization you represent (e.g., industry, consumer organization), and 
a brief summary of your presentation, if applicable (including the 
discussion topic(s) that will be addressed), to https://www.surveymonkey.com/s/2R5QWZP by January 18, 2013.
    FDA will notify registered presenters of their scheduled 
presentation times. Persons registered to make an oral presentation 
should check in before the

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hearing and are encouraged to arrive early to ensure the designated 
order of presentation times. We will try to accommodate all persons who 
wish to present; however, the duration of each speaker's testimony may 
be limited by time constraints. An agenda of the meeting and other 
background material will be made available 5 days before the meeting at 
http://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.
    Questions about the meeting may also be also submitted to 
IssuesWithOpioids@fda.hhs.gov prior to the February 7 and February 8, 
2013, meeting dates.
    The hearing is free and seating will be on a first-come, first-
served basis. Early registration is recommended because seating is 
limited. FDA may limit the numbers of participants from individual 
organizations as well as total number of attendees based on space 
limitations. Registrants will receive confirmation once they have been 
accepted to attend the hearing. For those who cannot attend in person, 
information regarding viewing a live Web cast of the public hearing 
will be located at: http://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.
    If you need special accommodations due to a disability, contact 
Elizabeth Giaquinto or Mary Gross (see FOR FURTHER INFORMATION 
CONTACT).

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by FDA senior management from the Center for Drug 
Evaluation and Research.
    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.
    The hearing will be transcribed as stipulated in Sec.  15.30(b). A 
transcript will be available for review at the Division of Dockets 
Management (see ADDRESSES) and on the Internet at http://www.regulations.gov within 30 days of the meeting. A transcript will 
also be available in either hard copy or on CD-ROM after submission of 
a Freedom of Information request. Submit written requests to the 
Division of Freedom of Information (ELEM-1029), Office of Management 
Programs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857.
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in Sec.  
15.30(h).

V. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments for consideration 
by April 8, 2013. Persons who wish to provide additional materials for 
consideration should file these materials with the Division of Dockets 
Management. You should annotate and organize your comments so that they 
identify the specific questions to which they refer. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in Division of Dockets Management between 
9 a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at http://www.regulations.gov.

    Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30516 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P


