[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44135-44137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0502]


Risk Evaluation and Mitigation Strategies: Understanding and 
Evaluating Their Impact on the Health Care Delivery System and Patient 
Access; Public Meeting, Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA or Agency) is announcing a 
public meeting entitled ``Risk Evaluation and Mitigation Strategies 
(REMS): Understanding and Evaluating Their Impact on the Health Care 
Delivery System and Patient Access''. The purpose of the public meeting 
is to engage in constructive dialogue and information sharing among 
regulators, the scientific community, the pharmaceutical industry, 
public health agencies, patients, patient advocates, health care system 
administrators, prescribers, dispensers, hospitals, infusion centers, 
health informatics experts, third-party payers, distributors, and the 
general public concerning the impact of REMS on the health care 
delivery system, including the impact on patients and health care 
providers. The discussion will focus on strategies for characterizing 
and evaluating the impact of REMS on the health care delivery system 
and on patient access to drugs subject to REMS.
    The primary focus of this meeting will be on REMS with Elements To 
Assure Safe Use (ETASU); however, the meeting will also include 
discussion of issues that may apply to all REMS. The input from this 
meeting and the public docket comments will be used to inform ongoing 
Agency initiatives related to optimizing REMS design, implementation, 
and assessment.
    Dates and Times: The meeting will be held on October 5, 2015, from 
8 a.m. to 5 p.m. and October 6, 2015, from 8 a.m. to 1 p.m.
    Location: The meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter 
through Building 1 and undergo security screening. For parking and 
security information, please visit http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Please arrive early to ensure time for parking and 
security screening.
    Contact Persons for meeting background and content: Megan Moncur, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
[email protected] .
    For registration, oral presentations, special accommodations, and 
other meeting logistics: Cherice Holloway, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, Phone 301-796-4909, FAX: 301-796-9832, 
[email protected].
    Registration and Requests for Oral Presentations: Registration is 
free and available on a first-come, first-served basis. You must 
register by September 21, 2015. Seating is limited, so register early. 
FDA may limit the number of participants from each organization. If 
time and space permit, onsite registration on the day of the meeting 
will be available. To register for this

[[Page 44136]]

meeting, please visit FDA's Drugs News & Events--Meetings, Conferences, 
& Workshops calendar at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm and select this meeting from the events list. If you need 
special accommodations because of a disability, please contact Cherice 
Holloway (see Contact Persons) at least 7 days before the meeting. 
Those without Internet access should contact Cherice Holloway to 
register.
    This meeting includes public comment sessions in which FDA is 
seeking input on improved approaches for understanding, evaluating, and 
minimizing burden on the health care delivery system to the extent 
practicable and for helping to assure patient access to drugs that are 
subject to REMS. If you would like to present during a session, please 
identify the topic(s) you will address during registration (see section 
II).
    FDA will do its best to accommodate requests to speak. FDA urges 
individuals and organizations with common interests to coordinate and/
or request time for a joint presentation. Following the close of 
registration, FDA will allot time for each presentation and notify 
presenters by September 28, 2015. Do not present or distribute 
commercial or promotional material during the meeting. Registered 
presenters should check in at the registration desk before the meeting.
    Live Webcast of the Meeting: To view the Connect Pro Webcast of 
this meeting, you must register online by 4 p.m., September 21, 2015. 
Webcast connections are limited, so register early. Organizations 
should register all viewers but access the Webcast using one connection 
per location.
    Webcast viewers will be sent system requirements after registration 
and will be sent connection information after September 28, 2015. Visit 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm 
for the Connect Pro Connection Test. To get a quick overview of Connect 
Pro, visit http://www.adobe.com/go/connectpro_overview. (FDA has 
verified the Web site addresses in this notice but is not responsible 
for any subsequent address changes after this document publishes in the 
Federal Register.)
    Comments: FDA is holding this public meeting to obtain information 
on improved strategies for evaluating and minimizing the burden of REMS 
on the health care delivery system to the extent practicable and their 
impact on patient access to the drugs covered by such programs. FDA is 
opening a public docket for comments to be submitted to the Agency on 
the issues and questions presented during the meeting. Regardless of 
attendance at the public meeting, interested persons may submit 
electronic or paper comments to FDA's Division of Dockets Management by 
November 2, 2015.
    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. Send only one set of comments. Identify all comments with the 
docket number found in brackets in the heading of this document. When 
addressing specific topics (see section II), please identify the topic. 
Received comments may be seen in the 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.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. The 
transcript may be viewed at the Division of Dockets Management (see 
Comments). A transcript will also be available in either hard copy or 
on CD-ROM after submission of a Freedom of Information request. Written 
requests are to be sent to the Division of Freedom of Information 
(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION:

I. Background

    This meeting builds on prior stakeholder feedback on the design, 
implementation, and assessment of REMS, including feedback obtained 
through public meetings, stakeholder outreach, and comments to the 
public docket, including the recommendations and suggestions recently 
summarized in the Agency's report entitled ``Standardizing and 
Evaluating Risk Evaluation and Mitigation Strategies'' (the 
Standardizing and Evaluating REMS Report).\1\ The report also describes 
the Agency's findings concerning strategies to standardize REMS, where 
appropriate, with the goal of reducing the burden of implementing REMS 
on health care providers, patients, and others in various health care 
settings.
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    \1\ In the Federal Register of September 23, 2014 (79 FR 56816), 
FDA published a notice announcing the availability of this draft 
report. The report is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm415751.pdf.
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    The Agency seeks to build on this foundation by updating 
stakeholders and obtaining their feedback on some of our current and 
proposed initiatives aimed at anticipating and minimizing REMS' burden 
on the health care delivery system, helping to assure access to drugs 
that are subject to REMS with ETASU, and obtaining stakeholder 
recommendations on additional approaches to accomplish these goals. The 
Agency recognizes that REMS can impose burden on the health care 
delivery system. The statute requires ETASU to be commensurate with the 
specific serious risks listed in a drug's labeling, and, considering 
such risks, not be unduly burdensome on patient access to the drug, 
and, to the extent practicable, to minimize burden on the health care 
delivery system. We are also seeking input on the methods for 
evaluating REMS' burden on the health care delivery system and their 
impact on patient access to drugs.
    The primary focus of this meeting will be on REMS with ETASU see 
section 505(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355-1(f)); however, the meeting will also include discussion of issues 
that may apply to all REMS.

II. Who Is the Target Audience and Who Should Attend This Public 
Meeting?

    This meeting is open to all interested parties. The target audience 
is comprised of regulators, the scientific community, the 
pharmaceutical industry, public health Agencies, patients, patient 
advocates, health care system administrators, prescribers, dispensers, 
hospitals, infusion centers, health informatics experts, third-party 
payers, distributors, and the general public who are interested in 
providing input on approaches for both anticipating and minimizing 
health care delivery system burden and for helping to assure patient 
access to drugs that are subject to REMS, as well as those interested 
in improving the approaches used to evaluate the burden of REMS on the 
health care delivery system and their impact on patient access.

III. What Are the Topics We Intend to Discuss at the Public Meeting?

    The meeting will include panel discussions and individual 
presentations. The main questions that will be considered are as 
follows: (1) How to anticipate and minimize the burden of REMS on the 
health care delivery system and patient access; and (2) how to improve 
the quality and effectiveness of methods used to evaluate REMS' burden 
on the health care delivery system and impact on patient access.

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    FDA will begin the meeting by soliciting feedback regarding how 
stakeholders, such as patients and health care providers, think about 
burden related to REMS. The meeting will then focus on strategies for 
anticipating and addressing REMS burden and access issues in several 
broad topic areas (including several areas identified in the key 
opinions and recommendations from stakeholders in the Standardizing and 
Evaluating REMS Report). Potential discussion topics are described in 
this document. For topics related to strategies for minimizing burden 
and barriers to patient access (topics 1-3), FDA will present ongoing 
and planned Agency initiatives, solicit feedback on these initiatives, 
and ask for feedback on other opportunities for anticipating and 
minimizing burden and patient access issues.
    Potential topics for discussion include the following:
     Topic 1: Understanding the stakeholder perspective.
    Discussion will focus on gaining a better understanding of how 
stakeholders, such as patients, health care providers, dispensers, and 
others, think about burden and access issues related to REMS--for 
example, understanding the different dimensions of burden (e.g., 
administrative, logistical, workflow) and better understanding the 
different types of patient access issues that are implicated by REMS.
     Topic 2: Improved communication about the existence of a 
REMS and about what is required of stakeholders under that REMS.
    Discussion will focus on strategies to improve communications about 
REMS, including communications about the existence of a particular REMS 
or the requirements under a particular REMS program, and how to improve 
the clarity of REMS materials.
     Topic 3: Improved integration of activities required under 
a REMS.
    Discussion will focus on two closely related subtopics: (1) 
Strategies to improve the integration of REMS requirements into the 
health care delivery system through process improvement (e.g., 
streamlining REMS processes that have an impact on stakeholder workflow 
or the care process, and reducing redundancies by leveraging existing 
training or certification requirements to meet REMS requirements); and 
(2) strategies to integrate REMS into electronic health care systems 
(e.g., electronic health records, decision support systems, and 
pharmacy management systems).
     Topic 4: Improved methods for measuring the burden of REMS 
on the health care delivery system and the impact on patient access.
    Discussion will focus on identifying the most effective methods for 
evaluating the burden of REMS on the health care delivery system and 
the impact on patient access, with a goal of not only characterizing 
and quantifying these effects, but also identifying opportunities for 
improvements to a REMS program and better understanding the effect of 
changes to a program. This may include discussion of how to address 
methodological challenges in the measurement of burden and access, and 
how to incorporate stakeholder input into REMS design and assessment.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the public meeting, and the background material will be posted on FDA's 
Web site after the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm, and to the docket at http://www.regulations.gov.

    Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18149 Filed 7-23-15; 8:45 am]
 BILLING CODE 4164-01-P