Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments, 45597-45600 [2017-20905]
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Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
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Friday.
• Confidential Submissions—To
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submission. You should submit two
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information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
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copy, which will have the claimed
confidential information redacted/
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www.regulations.gov. Submit both
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and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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docket number, found in brackets in the
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FOR FURTHER INFORMATION CONTACT:
Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
AMDAC@fda.hhs.gov, or the FDA
Advisory Committee Information Line,
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SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
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or before October 24, 2017. Time
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FDA may conduct a lottery to determine
the speakers for the scheduled open
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public hearing session. The contact
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20949 Filed 9–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5608]
Opioid Policy Steering Committee;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to solicit
suggestions, recommendations, and
comments from interested parties,
including patients and patient
representatives, health care
professionals, academic institutions,
regulated industry, and other interested
organizations, on questions relevant to
FDA’s newly established Opioid Policy
Steering Committee (OPSC). Opioid
addiction and the resulting overdoses
and deaths have created a national
crisis, which requires action by federal
agencies that may in some instances be
unprecedented in order to address the
situation and attempt to turn the tide on
the crisis. As a public health agency
SUMMARY:
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responding to the crisis, FDA seek
public input as it considers how its
authorities can or should be used to
address this crisis. This information will
help the Agency understand areas of
focus important to the public and
identify and address opioid product and
policy issues that need clarification.
FDA is especially interested in hearing
from interested parties in three key
areas: What more can FDA do to ensure
that the full range of available
information, including about possible
public health effects, is considered
when making opioid-related regulatory
decisions; what steps can FDA take with
respect to dispensing and packaging
(e.g., unit of use) to facilitate
consistency of and promote appropriate
prescribing practice; and should FDA
require some form of mandatory
education for health care professionals
who prescribe opioid drug products,
and if so, how should such a system be
implemented?
DATES: Submit either electronic or
written comments by December 28,
2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 28,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 28, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked, and
identified as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–5608 for ‘‘Opioid Policy
Steering Committee; Establishment of a
Public Docket; Request for Comments.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
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the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kathleen Davies, Office of Medical
Products and Tobacco, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 2310, Silver Spring,
MD 20993, 301–796–2205.
On April
19, 2017, the Secretary of Health and
Human Services announced the HHS
strategy for fighting the opioid crisis.
The five point strategy includes: (1)
Improving access to prevention,
treatment, and recovery services; (2)
targeting availability and distribution of
overdose-reversing drugs; (3)
strengthening timely public health data
and reporting; (4) supporting cuttingedge research; and (5) advancing the
practice of pain management. Following
that announcement, on May 23, 2017,
the Commissioner of Food and Drugs
announced his intention to take more
forceful steps to combat the opioid
crisis. An OPSC was established to
explore and develop additional tools or
strategies FDA can use to confront this
crisis. The OPSC has a broad mandate
to consider steps that FDA can take to
confront the opioid crisis. FDA is
seeking suggestions, recommendations,
and comments from interested parties,
including patients and patient
representatives, health care
professionals, academic institutions,
regulated industry, and other interested
organizations, with regard to a number
of topics related to three overarching
questions: (1) What more can or should
FDA do to ensure that the full range of
available information, including about
possible public health effects, is
considered when making opioid-related
regulatory decisions; (2) what steps can
or should FDA take with respect to
dispensing and packaging (e.g., unit of
use) to facilitate consistency of and
promote appropriate prescribing
practice; and (3) should FDA require
some form of mandatory education for
health care professionals who prescribe
opioid drug products, and if so, how
should such a system be implemented?
SUPPLEMENTARY INFORMATION:
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I. Assessing Benefit and Risk in the
Opioids Setting
In a July 6, 2017, article in the Journal
of the American Medical Association,
FDA explained its approach to assessing
the benefits and risks of drug products,
describing a structured approach that, in
the case of opioids, includes extensive
additional review of the risks related to
the potential misuse and abuse of these
products. FDA explained that it is
working to incorporate the effects of
decisions on public health into its
benefit-risk framework in a more
quantitative manner that can
supplement and enhance the strong
qualitative work that the Agency already
performs (Ref. 1). In addition, in March
2016, FDA commissioned a study from
the National Academies of Sciences,
Engineering, and Medicine to outline
the state of the science regarding
prescription opioid abuse and misuse,
the evolving role that opioid analgesics
play in pain management, and
additional actions FDA should consider
to address the opioid crisis with
particular emphasis on strengthening its
benefit-risk framework for opioids. That
report was issued in July (Ref. 2). While
FDA considers the report
recommendations, we would like to
solicit additional feedback that will
supplement those recommendations.
Specific questions on which FDA
seeks comment relating to this topic are
as follows:
1. How should FDA tailor, or
otherwise amend, its assessment of
benefit and risk in the context of opioid
drugs to ensure that the Agency is
giving adequate consideration to the
risks associated with the labeled
indication of these drugs and the risks
associated with the potential abuse and
misuse of these products?
2. Are there specific public health
considerations other than misuse and
abuse that FDA should incorporate into
its current framework for benefit and
risk assessment as a way to reduce the
opioid addiction epidemic? That
framework includes, but is not limited
to, how FDA makes regulatory decisions
to approve new opioids, evaluates their
use in the postmarket setting, or limits
or influences their prescribing through
product labeling or other risk
management measures.
II. Steps To Promote Proper Prescribing
and Dispensing
Proper prescribing and dispensing are
critical to successfully reducing opioid
misuse and abuse. A 2016 Centers for
Disease Control and Prevention (CDC)
Guideline for Prescribing Opioids for
Chronic Pain reported that, ‘‘[w]hen
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opioids are used for acute pain,
clinicians should prescribe the lowest
effective dose of immediate-release
opioids and should prescribe no greater
quantity than needed for the expected
duration of pain severe enough to
require opioids. Three days or less will
often be sufficient; more than seven
days will rarely be needed.’’ (Ref. 3.)
And a recent analysis showed that,
across six studies of patients who had
undergone a variety of surgical
procedures, 67 percent to 92 percent of
patients reported unused opioid
analgesics. Moreover, ‘‘[r]ates of safe
storage and/or disposal of unused
opioids were low,’’ resulting in an
‘‘important reservoir of unused opioids
available for nonmedical use . . . .’’
(Ref. 4). There are clinical situations
that may require a supply of opioid
analgesics that exceeds current CDC
guidelines and FDA wants to make sure
that patients have what they need in
those cases. But FDA believes there are
situations in which patients are
prescribed an opioid analgesic when a
non-opioid pain treatment would be
adequate or, when an opioid product is
necessary, treatment with a shorter
course of therapy would be more
appropriate, and without specific
requirements, variance in prescribing
habits are likely to persist.
Specific questions on which FDA
seeks comment relating to this topic are
as follows:
1. Should FDA consider adding a
recommended duration of treatment for
specific types of patient needs (e.g., for
specific types of surgical procedures) to
opioid analgesic product labeling? Or,
should FDA work with prescriber
groups that could, in turn, develop
expert guidelines on proper prescribing
by indication?
2. If opioid product labeling
contained recommended duration of
treatment for certain common types of
patient needs, how should this
information be used by FDA, other state
and Federal health agencies, providers,
and other intermediaries, such as health
plans and pharmacy benefit managers,
as the basis for making sure that opioid
drug dispensing more appropriately and
consistently aligns with the type of
patient need for which a prescription is
being written?
3. Are there steps FDA should take
with respect to dispensing and
packaging (e.g., unit of use) to facilitate
consistency of and promote appropriate
prescribing practice?
4. Are there other steps that FDA
should take to help promote the
prescribing of treatment durations that
are appropriately tailored to a clinical
patient need?
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III. Requirements for Prescriber
Education
Recently, the option of mandating
education or training for health care
professionals who prescribe opioid
medications has been more widely
discussed,1 and some states already are,
or are considering, mandating such
prescriber education. For example, as of
July 1, 2017, health care professionals in
New York State who are licensed to
prescribe controlled substances must
complete, and register their completion
of, at least 3 hours of course work or
training in pain management, palliative
care, and addiction (Ref. 5).
Specific questions on which FDA
seeks comment relating to this topic are
as follows:
1. Are there circumstances under
which FDA should require some form of
mandatory education for health care
professionals to ensure that prescribing
professionals are informed about
appropriate prescribing and pain
management recommendations,
understand how to identify the risk of
abuse in individual patients, know how
to get patients with a substance use
disorder into treatment, and know how
to prescribe treatment for—and properly
manage—patients with substance use
disorders, among other educational
goals? Are there other steps FDA could
take to educate health care professionals
to ensure that prescribing professionals
are informed about appropriate
prescribing and pain management
recommendations?
2. How might FDA operationalize
such a requirement if it were to pursue
this policy goal? For example, should
mandatory education apply to all
prescribing health care professionals, or
only a subset of prescribing health care
professionals? If only a subset, how
would FDA construct a framework that
focuses mandatory education on only
that subset—for example, by requiring
mandatory education only for those
writing prescriptions for longer
durations as opposed to those for very
short-term use?
3. What steps should FDA take to
make implementing such mandatory
education efficient and more feasible?
For example, should FDA work
collaboratively with state public health
agencies, state licensing boards,
provider organizations, such as medical
specialty societies and health plans, or
with other stakeholders, such as
1 FDA acknowledges the Joint Meeting of the Drug
Safety and Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug Products
Advisory Committee Meeting, held May 3–4, 2016,
discussed mandatory education for health care
professionals (Docket No. FDA–2016–N–0820).
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pharmacy benefit managers, to integrate
or avoid duplicating their educational
programs or requirements? What other
steps might FDA consider to make
implementation less burdensome and
more effective?
jamasurgery/fullarticle/2644905. Accessed
August 2017.
5. New York State Department of Health,
Mandatory Prescriber Education. Available at
https://www.health.ny.gov/professionals/
narcotic/mandatory_prescriber_education/.
Accessed August 2017.
IV. Additional Matters for
Consideration
Dated: September 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
1. What other steps should FDA take
to operationalize the above described
goals?
2. Are there additional policy steps
FDA should consider relating to the
OPSC that are not identified in this
notice?
We invite interested parties to review
these questions and submit comments to
the docket for the OPSC to consider. In
addition, we invite interested parties to
submit additional policy considerations
or recommendations for actions that
FDA could or should undertake to help
the Agency better address the opioid
addiction crisis.
V. References
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[HHS–OS–0990–0281–60D]
Agency Generic Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
1. Gottlieb, Scott and J. Woodcock.
‘‘Marshaling FDA Benefit-Risk Expertise to
Address the Current Opioid Abuse
Epidemic.’’ Journal of the American Medical
Association. 2017;318(5):421–422.
Doi:10.1001/jama.2017.9205. Available at
https://jamanetwork.com/journals/jama/
fullarticle/2643333. Accessed August 2017.
2. National Academies of Sciences,
Engineering, and Medicine. ‘‘Pain
Management and the Opioid Epidemic:
Balancing Societal and Individual Benefits
and Risks of Prescription Opioid Use (2017),
Consensus Study Report.’’ Richard J. Bonnie,
Morgan A. Ford, and Jonathan K. Phillips
(eds.). Available at https://www.nap.edu/
catalog/24781/pain-management-and-theopioid-epidemic-balancing-societal-andindividual. Accessed August 2017.
3. Dowell, D., T. M. Haegerich, and R.
Chou. ‘‘CDC Guideline for Prescribing
Opioids for Chronic Pain—United States,
2016.’’ Item 6 in ‘‘Determining When to
Initiate or Continue Opioids for Chronic
Pain.’’ Morbidity and Mortality Weekly
Report Recommendations and Reports
2016;65(No. RR–1):1–49. DOI: https://
dx.doi.org/10.15585/mmwr.rr6501e1.
Accessed August 2017.
4. Bicket, M. C., J. J. Long, P. J. Pronovost,
et al. ‘‘Prescription Opioid Analgesics
Commonly Unused After Surgery, A
Systematic Review.’’ JAMA Surgery.
Published online August 2, 2017.
DOI:10.1001/jamasurg.2017.0831. Available
at https://jamanetwork.com/journals/
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[FR Doc. 2017–20905 Filed 9–28–17; 8:45 am]
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before November 28,
2017.
SUMMARY:
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0281–60D
and project title for reference, to the
Report Clearance Officer, Sherrette
Funn.
ADDRESSES:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
SUPPLEMENTARY INFORMATION:
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
Prevention Communication Formative
Research—Revision—OMB No. 0990–
0281.
Abstract: The Office of Disease
Prevention and Health Promotion
(ODPHP) is focused on developing and
disseminating health information to the
public. ODPHP faces an increasingly
urgent interest in finding effective ways
to communicate health information to
America’s diverse population. ODPHP
strives to be responsive to the needs of
America’s diverse audiences while
simultaneously serving all Americans
across a range of channels, from print to
new communication technologies. To
carry out prevention information efforts,
ODPHP is committed to conducting
formative and usability research to
provide guidance on the development
and implementation of their
communication and education efforts.
The information collected will be used
to improve communication, products,
and services that support key office
activities including: Healthy People,
Dietary Guidelines for Americans,
Physical Activity Guidelines for
Americans, healthfinder.gov, and
increasing health care quality and
patient safety. ODPHP communicates
through its Web sites
(www.healthfinder.gov,
www.HealthyPeople.gov,
www.health.gov) and through other
channels including social media, print
materials, interactive training modules,
and reports. Data collection will be
qualitative and quantitative and may
include in-depth interviews, focus
groups, web-based surveys, omnibus
surveys, card sorting, and various forms
of usability testing of materials and
interactive tools to assess the public’s
understanding of disease prevention
and health promotion content,
responses to prototype materials, and
barriers to effective use.
The program is requesting a 3-year
clearance.
Likely Respondents: Respondents are
likely to be either consumers or health
professionals.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Data collection task
Instrument/form name
In-depth interviews ...............
Number of
respondents
Screener ...............................
Interview ...............................
Screener ...............................
Focus groups ........................
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500
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Number
responses/
respondent
Average burden/
response
(in hours)
1
1
1
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1.00
10/60
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Total response
burden
(in hours)
250
500
487.5
]]>Agencies
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Pages 45597-45600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5608]
Opioid Policy Steering Committee; Establishment of a Public
Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to solicit suggestions, recommendations,
and comments from interested parties, including patients and patient
representatives, health care professionals, academic institutions,
regulated industry, and other interested organizations, on questions
relevant to FDA's newly established Opioid Policy Steering Committee
(OPSC). Opioid addiction and the resulting overdoses and deaths have
created a national crisis, which requires action by federal agencies
that may in some instances be unprecedented in order to address the
situation and attempt to turn the tide on the crisis. As a public
health agency
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responding to the crisis, FDA seek public input as it considers how its
authorities can or should be used to address this crisis. This
information will help the Agency understand areas of focus important to
the public and identify and address opioid product and policy issues
that need clarification. FDA is especially interested in hearing from
interested parties in three key areas: What more can FDA do to ensure
that the full range of available information, including about possible
public health effects, is considered when making opioid-related
regulatory decisions; what steps can FDA take with respect to
dispensing and packaging (e.g., unit of use) to facilitate consistency
of and promote appropriate prescribing practice; and should FDA require
some form of mandatory education for health care professionals who
prescribe opioid drug products, and if so, how should such a system be
implemented?
DATES: Submit either electronic or written comments by December 28,
2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 28, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 28, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-5608 for ``Opioid Policy Steering Committee; Establishment
of a Public Docket; Request for Comments.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked ``confidential'' will not be
disclosed except in accordance with 21 CFR 10.20 and other applicable
disclosure law. For more information about FDA's posting of comments to
public dockets, see 80 FR 56469, September 18, 2015, or access the
information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kathleen Davies, Office of Medical
Products and Tobacco, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 2310, Silver Spring, MD 20993, 301-796-2205.
SUPPLEMENTARY INFORMATION: On April 19, 2017, the Secretary of Health
and Human Services announced the HHS strategy for fighting the opioid
crisis. The five point strategy includes: (1) Improving access to
prevention, treatment, and recovery services; (2) targeting
availability and distribution of overdose-reversing drugs; (3)
strengthening timely public health data and reporting; (4) supporting
cutting-edge research; and (5) advancing the practice of pain
management. Following that announcement, on May 23, 2017, the
Commissioner of Food and Drugs announced his intention to take more
forceful steps to combat the opioid crisis. An OPSC was established to
explore and develop additional tools or strategies FDA can use to
confront this crisis. The OPSC has a broad mandate to consider steps
that FDA can take to confront the opioid crisis. FDA is seeking
suggestions, recommendations, and comments from interested parties,
including patients and patient representatives, health care
professionals, academic institutions, regulated industry, and other
interested organizations, with regard to a number of topics related to
three overarching questions: (1) What more can or should FDA do to
ensure that the full range of available information, including about
possible public health effects, is considered when making opioid-
related regulatory decisions; (2) what steps can or should FDA take
with respect to dispensing and packaging (e.g., unit of use) to
facilitate consistency of and promote appropriate prescribing practice;
and (3) should FDA require some form of mandatory education for health
care professionals who prescribe opioid drug products, and if so, how
should such a system be implemented?
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I. Assessing Benefit and Risk in the Opioids Setting
In a July 6, 2017, article in the Journal of the American Medical
Association, FDA explained its approach to assessing the benefits and
risks of drug products, describing a structured approach that, in the
case of opioids, includes extensive additional review of the risks
related to the potential misuse and abuse of these products. FDA
explained that it is working to incorporate the effects of decisions on
public health into its benefit-risk framework in a more quantitative
manner that can supplement and enhance the strong qualitative work that
the Agency already performs (Ref. 1). In addition, in March 2016, FDA
commissioned a study from the National Academies of Sciences,
Engineering, and Medicine to outline the state of the science regarding
prescription opioid abuse and misuse, the evolving role that opioid
analgesics play in pain management, and additional actions FDA should
consider to address the opioid crisis with particular emphasis on
strengthening its benefit-risk framework for opioids. That report was
issued in July (Ref. 2). While FDA considers the report
recommendations, we would like to solicit additional feedback that will
supplement those recommendations.
Specific questions on which FDA seeks comment relating to this
topic are as follows:
1. How should FDA tailor, or otherwise amend, its assessment of
benefit and risk in the context of opioid drugs to ensure that the
Agency is giving adequate consideration to the risks associated with
the labeled indication of these drugs and the risks associated with the
potential abuse and misuse of these products?
2. Are there specific public health considerations other than
misuse and abuse that FDA should incorporate into its current framework
for benefit and risk assessment as a way to reduce the opioid addiction
epidemic? That framework includes, but is not limited to, how FDA makes
regulatory decisions to approve new opioids, evaluates their use in the
postmarket setting, or limits or influences their prescribing through
product labeling or other risk management measures.
II. Steps To Promote Proper Prescribing and Dispensing
Proper prescribing and dispensing are critical to successfully
reducing opioid misuse and abuse. A 2016 Centers for Disease Control
and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain
reported that, ``[w]hen opioids are used for acute pain, clinicians
should prescribe the lowest effective dose of immediate-release opioids
and should prescribe no greater quantity than needed for the expected
duration of pain severe enough to require opioids. Three days or less
will often be sufficient; more than seven days will rarely be needed.''
(Ref. 3.) And a recent analysis showed that, across six studies of
patients who had undergone a variety of surgical procedures, 67 percent
to 92 percent of patients reported unused opioid analgesics. Moreover,
``[r]ates of safe storage and/or disposal of unused opioids were low,''
resulting in an ``important reservoir of unused opioids available for
nonmedical use . . . .'' (Ref. 4). There are clinical situations that
may require a supply of opioid analgesics that exceeds current CDC
guidelines and FDA wants to make sure that patients have what they need
in those cases. But FDA believes there are situations in which patients
are prescribed an opioid analgesic when a non-opioid pain treatment
would be adequate or, when an opioid product is necessary, treatment
with a shorter course of therapy would be more appropriate, and without
specific requirements, variance in prescribing habits are likely to
persist.
Specific questions on which FDA seeks comment relating to this
topic are as follows:
1. Should FDA consider adding a recommended duration of treatment
for specific types of patient needs (e.g., for specific types of
surgical procedures) to opioid analgesic product labeling? Or, should
FDA work with prescriber groups that could, in turn, develop expert
guidelines on proper prescribing by indication?
2. If opioid product labeling contained recommended duration of
treatment for certain common types of patient needs, how should this
information be used by FDA, other state and Federal health agencies,
providers, and other intermediaries, such as health plans and pharmacy
benefit managers, as the basis for making sure that opioid drug
dispensing more appropriately and consistently aligns with the type of
patient need for which a prescription is being written?
3. Are there steps FDA should take with respect to dispensing and
packaging (e.g., unit of use) to facilitate consistency of and promote
appropriate prescribing practice?
4. Are there other steps that FDA should take to help promote the
prescribing of treatment durations that are appropriately tailored to a
clinical patient need?
III. Requirements for Prescriber Education
Recently, the option of mandating education or training for health
care professionals who prescribe opioid medications has been more
widely discussed,\1\ and some states already are, or are considering,
mandating such prescriber education. For example, as of July 1, 2017,
health care professionals in New York State who are licensed to
prescribe controlled substances must complete, and register their
completion of, at least 3 hours of course work or training in pain
management, palliative care, and addiction (Ref. 5).
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\1\ FDA acknowledges the Joint Meeting of the Drug Safety and
Risk Management Advisory Committee and the Anesthetic and Analgesic
Drug Products Advisory Committee Meeting, held May 3-4, 2016,
discussed mandatory education for health care professionals (Docket
No. FDA-2016-N-0820).
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Specific questions on which FDA seeks comment relating to this
topic are as follows:
1. Are there circumstances under which FDA should require some form
of mandatory education for health care professionals to ensure that
prescribing professionals are informed about appropriate prescribing
and pain management recommendations, understand how to identify the
risk of abuse in individual patients, know how to get patients with a
substance use disorder into treatment, and know how to prescribe
treatment for--and properly manage--patients with substance use
disorders, among other educational goals? Are there other steps FDA
could take to educate health care professionals to ensure that
prescribing professionals are informed about appropriate prescribing
and pain management recommendations?
2. How might FDA operationalize such a requirement if it were to
pursue this policy goal? For example, should mandatory education apply
to all prescribing health care professionals, or only a subset of
prescribing health care professionals? If only a subset, how would FDA
construct a framework that focuses mandatory education on only that
subset--for example, by requiring mandatory education only for those
writing prescriptions for longer durations as opposed to those for very
short-term use?
3. What steps should FDA take to make implementing such mandatory
education efficient and more feasible? For example, should FDA work
collaboratively with state public health agencies, state licensing
boards, provider organizations, such as medical specialty societies and
health plans, or with other stakeholders, such as
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pharmacy benefit managers, to integrate or avoid duplicating their
educational programs or requirements? What other steps might FDA
consider to make implementation less burdensome and more effective?
IV. Additional Matters for Consideration
1. What other steps should FDA take to operationalize the above
described goals?
2. Are there additional policy steps FDA should consider relating
to the OPSC that are not identified in this notice?
We invite interested parties to review these questions and submit
comments to the docket for the OPSC to consider. In addition, we invite
interested parties to submit additional policy considerations or
recommendations for actions that FDA could or should undertake to help
the Agency better address the opioid addiction crisis.
V. References
1. Gottlieb, Scott and J. Woodcock. ``Marshaling FDA Benefit-
Risk Expertise to Address the Current Opioid Abuse Epidemic.''
Journal of the American Medical Association. 2017;318(5):421-422.
Doi:10.1001/jama.2017.9205. Available at https://jamanetwork.com/journals/jama/fullarticle/2643333. Accessed August 2017.
2. National Academies of Sciences, Engineering, and Medicine.
``Pain Management and the Opioid Epidemic: Balancing Societal and
Individual Benefits and Risks of Prescription Opioid Use (2017),
Consensus Study Report.'' Richard J. Bonnie, Morgan A. Ford, and
Jonathan K. Phillips (eds.). Available at https://www.nap.edu/catalog/24781/pain-management-and-the-opioid-epidemic-balancing-societal-and-individual. Accessed August 2017.
3. Dowell, D., T. M. Haegerich, and R. Chou. ``CDC Guideline for
Prescribing Opioids for Chronic Pain--United States, 2016.'' Item 6
in ``Determining When to Initiate or Continue Opioids for Chronic
Pain.'' Morbidity and Mortality Weekly Report Recommendations and
Reports 2016;65(No. RR-1):1-49. DOI: https://dx.doi.org/10.15585/mmwr.rr6501e1. Accessed August 2017.
4. Bicket, M. C., J. J. Long, P. J. Pronovost, et al.
``Prescription Opioid Analgesics Commonly Unused After Surgery, A
Systematic Review.'' JAMA Surgery. Published online August 2, 2017.
DOI:10.1001/jamasurg.2017.0831. Available at https://jamanetwork.com/journals/jamasurgery/fullarticle/2644905. Accessed August 2017.
5. New York State Department of Health, Mandatory Prescriber
Education. Available at https://www.health.ny.gov/professionals/narcotic/mandatory_prescriber_education/. Accessed August 2017.
Dated: September 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20905 Filed 9-28-17; 8:45 am]
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