[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Proposed Rules]
[Pages 58572-58575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2017-N-6502]


Opioid Policy Steering Committee: Prescribing Intervention--
Exploring a Strategy for Implementation; Public Hearing; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public hearing entitled, ``Opioid Policy Steering 
Committee: Prescribing Intervention--Exploring a Strategy for 
Implementation.'' The purpose of the public hearing is to receive 
stakeholder input on how FDA might, under its Risk Evaluation and 
Mitigation Strategy (REMS) authority, improve the safe use of opioid 
analgesics by curbing overprescribing to decrease the occurrence of new 
addictions and limit misuse and abuse of opioid analgesics.

DATES: The public hearing will be held on January 30, 2018, from 8:30 
a.m. to 4:30 p.m. The public hearing may be extended or may end early 
depending on the level of public participation. Persons seeking to 
attend, or to present at, the public hearing must register by January 
16, 2018. Electronic or written comments will be accepted after the 
public hearing until March 16, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public hearing will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503 B and C), Silver Spring, MD 20993-0002. Entrance for public 
hearing participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered.

Electronic Submissions

    Electronic comments must be submitted on or before March 16, 2018. 
The https://www.regulations.gov

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electronic filing system will accept comments until midnight Eastern 
Time at the end of March 16, 2018. 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.
     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-6502 for ``Opioid Policy Steering Committee: Prescribing 
Intervention--Exploring a Strategy for Implementation; Public Hearing; 
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 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 as ``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, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2310, Silver 
Spring, MD 20993, 301-796-2205, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On May 23, 2017, the FDA Commissioner announced the establishment 
of an Opioid Policy Steering Committee (Steering Committee) to explore 
and develop additional approaches or strategies FDA could consider 
using to combat the opioid crisis. Given the unprecedented nature of 
the opioid crisis and the role of prescription opioids in the crisis, 
the Steering Committee is considering novel ways to reduce the number 
of new cases of addiction while continuing to ensure the benefits of 
opioid products outweigh their risks.
    Recent studies suggest that prescriptions for opioid analgesics are 
frequently dispensed for a number of tablets that exceed those needed 
for adequate pain control, particularly for acute pain. The Steering 
Committee is considering whether current prescribing patterns are 
contributing to the development of new addiction in patients, and 
whether the excess unused pills are a gateway to misuse, abuse, and 
addiction among family members and others who might have access to the 
unused pills. Therefore, the Steering Committee is exploring, by means 
of FDA's REMS authorities, the option of facilitating appropriate 
prescribing by requiring sponsors to implement a prescriber 
intervention at the point when the prescriber determines an opioid 
analgesic prescription is necessary for a patient. For example, a REMS 
could impact prescribing by requiring that sponsors ensure that 
prescribers provide specific documentation for a prescription above a 
specified amount, such as a statement that the quantity prescribed is 
medically necessary for the patient. The documentation requirement 
would not be intended to prevent access for patients in whom chronic 
use of opioid analgesics is the most appropriate therapy. Instead, it 
would be designed to ensure that prescribers consider whether the 
amount prescribed is appropriate for the patient and, if above the 
specified amount, document that necessity. The Steering Committee's 
view is that one way sponsors could implement this type of prescribing 
documentation requirement is through an electronic system at the point 
of prescribing (i.e., incorporated into the prescriber's workflow) to 
minimize the burden on patient access and on the health care delivery 
system. Thus, the Steering Committee is interested in exploring 
evidence-based approaches that would encourage electronic prescribing 
as a mechanism for the prescriber to provide documentation of a safe-
use condition (e.g., that the quantity prescribed is medically 
necessary for the patient) before the drug is dispensed by the 
pharmacy. The Steering Committee also seeks input from the public on 
alternative REMS models or approaches for consideration.

II. Topics for Discussion at the Public Hearing

    In this public hearing, FDA seeks stakeholder input on new 
approaches to promote the safe use of opioid analgesics using FDA's 
REMS

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authorities. FDA is seeking feedback from a broad group of 
stakeholders, both private and public, who are working on the 
challenges of improving pain management while addressing the opioid 
epidemic. The Agency is also particularly interested in ensuring that 
any REMS intervention minimizes the burden on patient access and, to 
the extent practicable, on the health care delivery system. Relevant 
questions for consideration are provided below.

Prescriber Documentation

    Many REMS programs rely on pharmacies to verify that required safe-
use conditions have been documented prior to dispensing a drug product. 
One alternative approach under consideration would require sponsors to 
ensure that prescribers follow specific requirements outlined in the 
REMS for each opioid analgesic prescription for a quantity above a 
specified amount. This approach could involve use of an electronic 
system (e.g., electronic prescribing integrated into a prescriber's 
workflow) that would require prescribers to specifically document the 
medical necessity of the quantity prescribed for a particular patient. 
This documentation would be verified before the prescription reaches 
the pharmacy. For prescribers who intend to prescribe below the 
specified amount, no additional documentation of medical necessity or 
electronic prescription would be required.
    1. If a REMS were to specify threshold drug amounts for opioid 
analgesic prescriptions above which prescribers would be required to 
provide additional documentation of medical necessity, what should the 
amounts be and how should they be determined for various clinical 
indications? What data are there to support such amounts? What 
additional data would be useful?
    2. If such measures were required, how should prescribers be made 
aware of them? Within the Agency's statutory REMS authority, how should 
the Agency require sponsors to ensure compliance with them? How should 
the Agency require sponsors to assess their effect in reducing misuse, 
abuse, and new addictions?

Additional REMS Approaches

    Health care providers generally have the capability to access state 
prescription drug monitoring program (PDMP) data that include patient 
prescription history and prescribing patterns. PDMPs are separately 
managed and maintained by the individual states, which may result in 
disparate data elements and data sharing challenges. Additionally, 
review of PDMP data requires health care providers to access a database 
that may not be integrated into their workflow.
    Either in conjunction with, or separate from, the prescriber 
intervention approach discussed above, the Steering Committee is 
considering whether to require sponsors to create a system that would 
leverage a nationwide database to be more effective in helping health 
care providers identify potential misuse and abuse (e.g., doctor 
shopping) and facilitate safe use of opioid analgesics (e.g., real-time 
identification of potential harmful drug-drug combinations). Such an 
approach could be integrated into the health care provider's workflow 
to minimize burden on the health care system.
    3. The Steering Committee requests input from the public on 
whether, in addition to, or in conjunction with the above described 
prescriber intervention, and to the extent consistent with its 
statutory authority, the Agency should consider requiring sponsors to 
create a system that utilizes a nationwide prescription history 
database to facilitate safe use of opioid analgesics.
    4. If this approach were adopted, how should the Agency require 
sponsors to assess the impact of such requirements?

Additional Considerations

    The Steering Committee acknowledges that the approaches described 
above emphasize specific components within the opioid prescribing 
pathway and might not address other areas where misuse and abuse may be 
occurring. The Steering Committee seeks input from the public on 
additional approaches the Agency may consider, within its statutory 
authority, to reduce misuse, abuse, and addiction associated with 
opioid analgesics.
    5. The proposed Opioid Analgesics REMS includes a Medication Guide 
and a Patient Counseling Document to educate patients. It also includes 
a Blueprint for Health Care Providers Involved in the Management or 
Support of Patients with Pain that contains information on counseling 
patients and caregivers about the safe use of opioid analgesics. 
Consistent with its statutory authority, should FDA require sponsors to 
take additional measures to ensure that health care providers, their 
patients, and patient caregivers and family members are educated on 
safe storage and disposal and the risks of misuse, abuse, and addiction 
associated with opioid analgesics (e.g., a public health campaign 
targeted at these groups)?
    6. Should the Agency consider additional measures intended to 
improve the safety of patient storage and handling of opioid 
analgesics?
    7. How might use of unit-of-use packaging play a role in 
encouraging appropriate prescribing of opioid analgesics?
    8. Should the Agency require sponsors to create a mechanism by 
which patients could return unused pills, and if so, to whom?

III. Participating in the Public Hearing

    Registration: The FDA Conference Center at White Oak is a Federal 
facility with security procedures and limited seating. Attendance will 
be free and on a first-come, first-served basis. If you wish to attend, 
either in person or by webcast (see Streaming Webcast of the Public 
Hearing), and/or present at the hearing, please register for the 
hearing and/or make a request for oral presentations or comments at 
https://www.eventbrite.com/e/opioid-policy-steering-committee-tickets-39490940466 by January 16, 2018, and provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone.
    FDA will try to accommodate all persons who wish to make a 
presentation. Individuals wishing to present should identify the number 
of the question, or questions, they wish to address. This will help FDA 
organize the presentations. Individuals and organizations with common 
interests should consolidate or coordinate their presentations and 
request time for a joint presentation. FDA will notify registered 
presenters of their scheduled presentation times. Time allotted for 
each presentation will depend on the number of individuals who wish to 
speak. Once FDA notifies registered presenters of their scheduled 
times, they are encouraged to submit an electronic copy of their 
presentation (.DOC, .DOCX, .PPT, .PPTX, .XLS, .XLSX, .PDF formats 
preferred) to [email protected] on or before January 22, 
2018. No commercial or promotional material will be permitted to be 
presented or distributed at the public hearing. Persons registered to 
make an oral presentation are encouraged to arrive at the hearing room 
early and check in at the onsite registration table to confirm their 
designated presentation time. An agenda for the hearing and any other 
background materials will be made available 3 days before the hearing 
at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm583543.htm.

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    If you need special accommodations due to a disability, please 
contact Kathleen Davies at least 7 days before the hearing.
    Streaming Webcast of the Public Hearing: This public hearing will 
also be webcast for those unable to attend in person. To join the 
hearing via the webcast, please go to https://collaboration.fda.gov/opsc.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public hearing is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

IV. Notice of Public 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, accompanied by FDA 
senior management from the Office of the Commissioner and the relevant 
centers/offices. Under Sec.  15.30(f) (21 CFR 15.30(f)), the hearing is 
informal and the rules of evidence do not apply. Only the presiding 
officer and panel members may question any person during or at the 
conclusion of each presentation (Sec.  15.30(e)). Public hearings under 
part 15 are subject to FDA's policy and procedures for electronic media 
coverage of FDA's public administrative proceedings (21 CFR part 10, 
subpart C) (Sec.  10.203(a)). 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) (see section V). To the 
extent that the conditions for the hearing as described in this 
document 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).

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26785 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P