[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75177-75179]
From the Federal Register Online via the Government Publishing 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,
[email protected]; or Mary Gross, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD
20903, 301-796-3519, FAX: 301-847-8752, [email protected].
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
[email protected] 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