[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]


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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

[[Page 45598]]

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?

[[Page 45599]]

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 http://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: http://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 http://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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