[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Notices]
[Pages 6567-6568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2757]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0067]
Assessment of Analgesic Treatment of Chronic Pain--A Public
Workshop; Request for Comments
AGENCY: Food and Drug Administration.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA), Center for Drug Evaluation
and Research (CDER), is announcing a public workshop to hear a
discussion of the available data on the efficacy of analgesics in the
treatment of chronic non-cancer pain (CNCP). The focus of the
presentations and discussions by scientific experts and other
stakeholder
[[Page 6568]]
groups will be on the available clinical data from both randomized
clinical trials and other studies of the efficacy of opioid analgesics,
and comparison of that data to the data from studies of non-opioid
analgesics used in the treatment of CNCP.
Date and Time: The public workshop will be held on May 30, 2012,
from 1 p.m. to 5:15 p.m. and on May 31, 2012, from 8:30 a.m. to 5 p.m.
Location: The workshop will be held at the Natcher Auditorium,
Natcher Conference Center, National Institutes of Health Campus, 45
Center Dr., Bethesda, MD 20892.
Contacts: Mary C. Gross, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm.
6178, Silver Spring, MD 20993-0002, (301) 796-3519; or Matthew
Sullivan, Center for Drug Evaluation, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 3160, Silver Spring, MD 20993-
0002, (301) 796-1245.
Registration: If you wish to attend the workshop or provide oral
comments during the open session of the meeting, please email your
registration to CDER--ChronicPain--Workshop @FDA.HHS.GOV by May 15,
2012. Those without email access may register by contacting one of the
persons listed in the Contacts section of the document. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email address, and telephone number. Registration
is free and will be on a first-come, first-served basis. Registrants
will receive confirmation once they have been accepted for the
workshop. Onsite registration on the day of the meeting will be based
on space availability. If registration reaches maximum capacity, FDA
will post a notice closing the meeting registration for the workshop
at: http://www.fda.gov/Drugs/NewsEvents/ucm283979.htm.
An open session of the meeting will be held between 3:45 p.m. and 5
p.m. on May 30, 2012, during which time public comments will be
accepted. We will try to accommodate all persons who wish to speak at
this open session; however, the duration of each speaker's testimony
may be limited by time constraints.
Comments: Submit either electronic or written comments by August 1,
2012. 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. 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 the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
If you need special accommodations due to a disability, contact
Mary Gross or Matthew Sullivan (see Contacts) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION:
I. Introduction
CNCP is a major cause of pain and disability for millions of
Americans. The prescribing of opioids for pain has risen steadily in
the United States over the past two decades, including the prescribing
of opioids to treat CNCP. Questions have been raised about the efficacy
of opioids in the treatment of CNCP, including which patients benefit
from the chronic use of opioids, the durability of analgesia provided
by opioid analgesics, and how best to manage the use of these drugs.
Addressing this uncertainty begins with a discussion of the available
scientific data on the use of opioids in chronic painful conditions.
The discussion will include health care professionals, clinical
investigators, regulators, manufacturers, patients, caregivers, and
advocacy groups. Where gaps in our knowledge are identified, it will be
important to discuss the research that needs to be undertaken to better
understand the effectiveness of all analgesics for the treatment of
chronic non-cancer pain, and opioid analgesics in particular.
The purpose of the meeting is to provide a forum to discuss the
available data on the use of analgesics in the treatment of CNCP,
beginning with a discussion of the underlying mechanisms of chronic
pain and the epidemiology of chronic pain in the United States. Next,
data on the efficacy of opioids and other analgesics in the treatment
of chronic pain from a variety of sources will be reviewed. Those
sources will include randomized controlled trials, epidemiological
studies, case series and other types of studies. Patient and clinician
perspectives on the pharmaceutical treatment of CNCP will be presented
by people living with chronic pain and those who treat or care for
patients with chronic pain. Finally, a general assessment of the
available data and discussion of future research needs and next steps
will be used to inform future actions that can help guide appropriate
therapy for patients with CNCP.
FDA will be considering the following questions during the
workshop:
1. What is currently known about the mechanisms of chronic pain?
2. How might this knowledge affect the use of pharmaceuticals
chronically for the treatment of pain?
3. What is known regarding use of pain biomarkers (e.g.,
phenotyping, imaging, genotyping)?
4. What is known about the sources of chronic pain, the populations
affected by it, and trends in current use of pharmaceuticals in its
treatment?
5. What data are available from controlled trials that have
examined the use of pharmaceuticals in the treatment of chronic pain?
6. What data are available from other sources on the use of
pharmaceuticals in the treatment of chronic pain?
7. Can populations and individuals who would benefit from chronic
use of pharmaceuticals be identified?
8. Can individuals at high risk for adverse effects be identified?
9. What more should be known about the use of pharmaceuticals to
treat chronic pain?
FDA will post the agenda and additional workshop background
material approximately 5 days before the workshop at http://www.fda.gov/Drugs/NewsEvents/ucm283979.htm.
II. Transcripts
Please be advised that approximately 30 days after the public
workshop, a transcript will be available. It will be accessible at
http://www.regulations.gov and may be viewed at the Division of Dockets
Management (see Comments). A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: February 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2757 Filed 2-7-12; 8:45 am]
BILLING CODE 4160-01-P