[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58313-58314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23019]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1041]
Fibromyalgia Public Meeting on Patient-Focused Drug Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for fibromyalgia. Patient-Focused Drug Development is part
of FDA's performance commitments in the fifth authorization of the
Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patients' perspectives on the impact of
fibromyalgia on daily life as well as the available therapies for
fibromyalgia.
DATES: The public meeting will be held on December 10, 2013, from 1
p.m. to 5 p.m. Registration to attend the meeting must be received by
November 27, 2013. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting. Submit electronic or
written comments by February 10, 2013.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31 Conference Center, in Section A of the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
meeting participants is through Building 1, where routine security
check procedures will be performed. For more information on parking and
security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to 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. All
comments should be identified with the docket number found in brackets
in the heading of this document.
FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm363203.htm.
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected fibromyalgia as the focus of a meeting under
Patient-Focused Drug Development, an initiative that involves obtaining
a better understanding of patients' perspectives on the severity of the
disease and the available therapies for the condition. Patient-Focused
Drug Development is being conducted to fulfill FDA's performance
commitments made as part of the authorization of PDUFA V under Title I
of the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-
144). The full set of performance commitments is available on the FDA
Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA has committed to obtain the patient perspective in twenty
disease areas during the course of PDUFA V. For each disease area, the
Agency will conduct a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient community, and other
interested stakeholders.
On April 11, 2013, FDA published a notice (78 FR 08441) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V
timeframe. To develop the list of disease areas, the Agency used
several criteria that were outlined in the April 11 notice. The Agency
obtained public comment on these criteria and potential disease areas
through a notice for public comment published in the Federal Register
on September 24, 2012 (77 FR 23454, and through a public meeting held
on October 25, 2012. In selecting the disease areas, FDA carefully
considered the public comments received and the perspectives of its
review divisions. By the end of FY 2015, FDA will initiate another
public process for determining the disease areas for FY 2016-2017. More
information, including the list of disease areas and a general schedule
of meetings, is posted on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on symptoms of fibromyalgia that
matter most to patients and on current approaches to treating
fibromyalgia. Fibromyalgia is a chronic disorder characterized by
widespread musculoskeletal pain and tenderness in multiple tender
points and may be accompanied by fatigue, sleep disturbances, irritable
bowel syndrome, headache, and mood disorders. While there is currently
no definitive cure, treatments for fibromyalgia include medications and
lifestyle changes with emphasis on minimizing symptoms and improving
general health and daily function. FDA is interested in obtaining a
better understanding of fibromyalgia patients' perspectives on the
severity of the disease and the available therapies used to treat
fibromyalgia and its symptoms.
The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief patient panel discussion will begin the
dialogue, followed by a facilitated discussion inviting comments from
[[Page 58314]]
other patient and patient stakeholder participants. In addition to
input generated through this public meeting, FDA is interested in
receiving patient input addressing these questions through written
comments that can be submitted to the public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
(1) Of all the symptoms that you experience because of your
condition, which 1-3 symptoms have the most significant impact on your
life? (Examples may include chronic pain, fatigue, difficulty
concentrating, sleep disorders, etc.)
(2) Are there specific activities that are important to you but
that you cannot do at all or as fully as you would like because of your
condition? (Examples of activities may include sleeping through the
night, daily hygiene, driving, household chores, etc.)
(a) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
(3) How have your condition and its symptoms changed over time?
(a) Do your symptoms come and go? If so, do you know of anything
that makes your symptoms better? Worse?
(4) What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treating
Fibromyalgia
(1) What are you currently doing to help treat your condition or
its symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such
as exercise or acupuncture)
(a) What specific symptoms do your treatments address?
(b) How has your treatment regimen changed over time, and why?
(2) How well does your current treatment regimen treat the most
significant symptoms of your disease?
(a) How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
(b) How well have these treatments worked for you as your condition
has changed over time?
(3) What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, going to the hospital
for treatment, restrictions on driving, etc.)
(4) What specific things would you look for in an ideal treatment
for your condition?
B. Meeting Attendance and/or Participation
If you wish to attend this meeting, visit https://patientfocusedfibromyalgia.eventbrite.com. Please register by November
27, 2013. Those who are unable to attend the meeting in person can
register to view a live webcast of the meeting. You will be asked to
indicate in your registration whether you plan to attend in person or
via the webcast. Your registration should also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of disability, please contact Graham
Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. These patients will
also be asked to send a brief summary of responses to the topic
questions to [email protected]. Panelists will be notified of
their selection soon after the close of registration on November 27,
2013. FDA will try to accommodate all patients and patient stakeholders
who wish to speak, either through the panel discussion or audience
participation; however, the duration of comments may be limited by time
constraints.
Interested members of the public, including those who attend the
meeting in person or through the webcast, are invited to provide
electronic or written responses to the questions pertaining to Topics 1
and 2 to the public docket (see ADDRESSES). Comments may be submitted
until February 10, 2013.
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23019 Filed 9-20-13; 8:45 am]
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