[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7616-7617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0244]


Patient-Focused Drug Development for Functional Gastrointestinal 
Disorders; Public Meeting; Request for Comments

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 or Agency) is announcing 
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for functional gastrointestinal (GI) 
disorders, including irritable bowel syndrome, gastroparesis, chronic 
persistent symptomatic gastroesophageal reflux despite standard 
therapeutic interventions, and chronic idiopathic constipation. 
Patient-Focused Drug Development is part of FDA's performance 
commitments made as part of the fifth authorization of the Prescription 
Drug User Fee Act (PDUFA V). The public meeting is intended to allow 
FDA to obtain patient perspectives on the impact of functional GI 
disorders on daily life and patient views on treatment approaches.

DATES: The public meeting will be held on May 11, 2015, from 1 p.m. to 
5 p.m. Registration to attend the meeting must be received by May 1, 
2015 (see SUPPLEMENTARY INFORMATION for instructions). Submit 
electronic or written comments to the public docket by July 13, 2015.

ADDRESSES: 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 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/ucm430885.htm.

FOR FURTHER INFORMATION CONTACT: Pegah Mariani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-4513, FAX: 301-847-8443, <a href="/cdn-cgi/l/email-protection#e2b1839b9b8786878accaf83908b838c8ba2848683cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="0556647c7c6061606d2b4864776c646b6c456361642b6d6d762b626a73">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected functional GI disorders as the focus of a public 
meeting under Patient-Focused Drug Development, an initiative that 
involves obtaining a better understanding of patient perspectives on 
the severity of a disease and the available therapies for that 
condition. Patient-Focused Drug Development is being conducted to 
fulfill FDA performance commitments that are part of the 
reauthorization of the PDUFA under Title I of the Food and Drug 
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). 
The full set of performance commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on 20 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 communities, and other 
interested stakeholders.
    On April 11, 2013, FDA published a document in the Federal Register 
(78 FR 21613) announcing the disease areas for meetings in fiscal years 
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V timeframe. The 
Agency used several criteria outlined in that document to develop the 
list of disease areas. FDA obtained public comment on the Agency's 
proposed criteria and potential disease areas through a public docket 
and a public meeting that was convened on October 25, 2012. In 
selecting the set of disease areas, FDA carefully considered the public 
comments received and the perspectives of review divisions at FDA. FDA 
has initiated a second 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 at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    The purpose of this Patient-Focused Drug Development meeting is to 
obtain input on the symptoms and other impacts of functional GI 
disorders, such as irritable bowel syndrome, gastroparesis, chronic 
persistent symptomatic gastroesophageal reflux despite standard 
therapeutic interventions, and chronic idiopathic constipation, that 
matter most to patients, as well as perspectives on current approaches 
to treating these conditions. Functional GI disorders are common 
disorders that are characterized by persistent and recurring GI 
symptoms and occur as a result of abnormal functioning of the GI tract. 
These disorders are not caused by structural abnormalities, thus 
routine medical tests may be normal, and diagnosis is based primarily 
on symptoms. Functional GI disorders can affect any part of the GI 
tract, including the esophagus, bile duct, and intestines. Treatment 
for functional GI disorders focuses on management of different symptoms 
over a period of time. Treatments may include dietary management as 
well as over-the-counter and prescription medications (e.g., 
antispasmodics, pro-motility agents, antidiarrheals, and 
antidepressants). In addition, psychological treatments, such as 
relaxation therapy or cognitive behavioral therapy, may help manage the 
symptoms of functional GI disorders.
    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 initial patient panel discussion will 
begin the dialogue. This will be followed by a facilitated discussion 
inviting comments from other patient and patient stakeholder 
participants. In

[[Page 7617]]

addition to input generated through this public meeting, FDA is 
interested in receiving patient input addressing these questions 
through written comments, which can be submitted to the public docket 
(see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to 
Patients
    <bullet> Have you received a diagnosis of a functional GI disorder 
from a health care provider? If so, please state the condition.
    <bullet> Of all the symptoms that you experience because of your 
condition, which one to three symptoms have the most significant impact 
on your life? (Examples may include pain, bloating, constipation, 
vomiting)
    <bullet> 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)
    [cir] How do your symptoms and their negative impacts affect your 
daily life on the best days? On the worst days?
    <bullet> How has your condition and its symptoms changed over time?
    [cir] Do your symptoms come and go or are they ongoing? If so, do 
you know of anything that worsens your symptoms?
    <bullet> What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches To Treating 
Functional GI Disorders
    <bullet> 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 nondrug therapies 
such as diet modification.)
    [cir] What specific symptoms do your treatments address?
    [cir] How has your treatment regimen changed over time, and why?
    <bullet> How well does your current treatment regimen treat the 
most significant symptoms of your disease?
    [cir] How well do these treatments stop or slow the progression of 
your condition?
    [cir] How well do these therapies improve your ability to do 
specific activities that are important to you in your daily life?
    [cir] How well have these treatments worked for you as your 
condition has changed over time?
    <bullet> 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.)
    <bullet> Assuming there is no complete cure for your condition, 
what specific things would you look for in an ideal treatment for your 
condition?

B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit http://pfddfunctionalgidisorders.eventbrite.com. Please register by May 1, 
2015. If you are unable to attend the meeting in person, you can 
register to view a live Webcast of the meeting. You will be asked to 
indicate in your registration if you plan to attend in person or via 
the Webcast. 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 a disability, please contact Pegah 
Mariani (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 also 
must send to <a href="/cdn-cgi/l/email-protection#7f2f1e0b161a110b39101c0a0c1a1b3f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="d585b4a1bcb0bba193bab6a0a6b0b195b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a> a brief summary of responses to 
the topic questions by April 24, 2015. Panelists will be notified of 
their selection approximately 7 days before the public meeting. We 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.

III. Comments

    Regardless of whether you attend the public meeting, you can submit 
electronic or written responses to the questions pertaining to Topics 1 
and 2 to the public docket (see ADDRESSES) by July 13, 2015. 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.

IV. Transcripts

    As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm430885.htm.

    Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02804 Filed 2-10-15; 8:45 am]
BILLING CODE 4164-01-P


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