[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57942-57944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22983]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1413]


Patient-Focused Drug Development Public Meeting and Scientific 
Workshop on Female Sexual Dysfunction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting and scientific workshop, both of which will provide an 
opportunity for public comment on the topic of Female Sexual Interest/
Arousal Disorder (FSIAD), the most common form of female sexual 
dysfunction. FSIAD is a diagnosis that combines two previously distinct 
disorders--hypoactive sexual desire disorder (HSDD) and female sexual 
arousal disorder (FSAD). The public meeting will take place on October 
27, 2014, and is part of FDA's Patient-Focused Drug Development 
performance commitments made as part of the fifth authorization of the 
Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will 
obtain patients' perspectives on the impact that FSIAD (or a prior 
diagnosis of HSDD or FSAD) has on their daily lives, as well as their 
perspectives on the available therapies for these conditions. The 
scientific workshop will take place on October 28, 2014, and will 
provide an opportunity for FDA to seek input from experts on scientific 
issues important to the clinical development of drug products intended 
to treat FSIAD.

DATES: The meeting will be held on October 27, 2014, from 12 p.m. to 5 
p.m. and the workshop will be held on October 28, 2014, from 8 a.m. to 
5 p.m. Registration to attend either the meeting or the workshop must 
be received by October 17, 2014. See the SUPPLEMENTARY INFORMATION 
section for information on how to register for either the meeting or 
the workshop. Submit electronic or written comments by December 29, 
2014.

ADDRESSES: The meeting and workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Sections 
B/C of the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for 
the public meeting and workshop participants (non-FDA employees) is 
through Building 1 where routine security check procedures will be 
performed. For parking and security information, 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, Room 1061, Rockville, MD 20852. All 
comments should be identified with the

[[Page 57943]]

docket number found in brackets in the heading of this document. Please 
indicate whether the comments are relevant to the October 27 meeting or 
the October 28 workshop. FDA will post the agenda approximately 5 days 
before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.

FOR FURTHER INFORMATION CONTACT:
    For questions regarding the October 27 Patient-Focused Drug 
Development meeting: Pujita Vaidya, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 1144, Silver Spring, MD 20993, 301-796-0684, FAX: 301-847-8443, 
[email protected].
    For questions regarding the October 28 scientific workshop: 
Charlene Williamson, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5332, 
Silver Spring, MD 20993, 301-796-1025, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected female sexual dysfunction as the focus of a 
meeting under Patient-Focused Drug Development initiative that involves 
obtaining a better understanding of patients' perspectives on the 
severity of the disease and the available therapies for the condition. 
This Patient-Focused Drug Development meeting 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 
(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 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 community, and other interested 
stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register 
(78 FR 21613) announcing the disease areas for meetings in fiscal years 
(FYs) 2013 through 2015, the first 3 years of the 5-year PDUFA V time 
frame. 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 58849), 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 to determine the disease areas for FYs 2016 through 
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 and Workshop Information

A. Purpose and Scope of the Meeting and Workshop

    On October 27, 2014, as part of Patient-Focused Drug Development, 
FDA will obtain patient and patient stakeholder input on symptoms of 
female sexual dysfunction that matter most to patients and on current 
approaches to treating female sexual dysfunction. The most common form 
of female sexual dysfunction, FSIAD, refers to absent or reduced sexual 
interest/arousal that causes clinically significant distress and is not 
caused by another condition (such as another medical disorder or the 
effects of medications). There are no FDA-approved drug therapies to 
treat FSIAD. FDA is committed to working with all stakeholders to 
foster the development of safe and effective therapies for affected 
women.
    The questions that will be asked of patients and patient 
stakeholders at the meeting are listed in this section and organized by 
topic. For each topic, a brief patient panel discussion will begin the 
dialogue, followed by a facilitated discussion inviting comments from 
other patients and patient stakeholders. In addition to input received 
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).
1. Topic 1: Disease Symptoms and Daily Impacts That Matter Most to 
Patients
     Have you ever received a diagnosis from a healthcare 
provider of sexual interest/arousal disorder, hypoactive sexual desire 
disorder, or sexual arousal disorder?
     How was the diagnosis made? For example, what type of 
healthcare provider made the diagnosis? Were any tests or 
questionnaires used to help make the diagnosis?
     Of all the symptoms that you experience because of your 
condition, which 1 to 3 symptoms have the most significant impact on 
your life? Please describe each symptom in detail, including how this 
symptom specifically affects your sexual experiences.
     Do your symptoms wax and wane over time? For example, do 
you have better days and worse days? If your symptoms wax and wane, 
please answer the following questions:
     Which symptoms vary the most, and in what ways?
     How do your symptoms and their negative impacts on your 
sexual experiences compare between your ``best days'' and your ``worst 
days''?
     Do the changes in your symptoms typically happen over a 
period of minutes, hours, days, weeks, or months?
     If you were asked today to accurately rate how good or how 
bad your symptoms have been over time, would you be able to accurately 
remember how your symptoms felt one day ago? Over the past 3 days? Over 
the past week? Over the past 2 weeks? Over the past 3 weeks? Over the 
past month?
     Is there anything else that you believe makes your 
symptoms better? Is there anything that you believe makes your symptoms 
worse? For example, menstruation, stress, etc.
     Overall, have you experienced your condition and its 
symptoms getting progressively worse, improving, or remaining stable 
over the past few years?
     What worries you most about your condition?
2. Topic 2: Patient perspectives on Current Approaches To Treat FSIAD
     What are you currently doing to help treat your condition 
or its symptoms? (Examples may include prescription medicines, over-
the-counter products, physical or other therapies, support groups, and 
lifestyle changes.)
     How well do your current treatments specifically treat the 
most significant symptoms of your condition?
     How well have your treatments improved your sexual 
experience?
     How has your treatment regimen changed over time, and why?
     Are there any downsides to the treatments you have used? 
(Examples of downsides may include bothersome

[[Page 57944]]

side effects, difficulty identifying appropriate healthcare providers, 
etc.)
     What specific things would you look for in an ideal 
treatment for your condition? For example, which symptom would you most 
like a treatment to target and what would you consider to be a 
meaningful improvement in this symptom?
    The scientific workshop on October 28, 2014 will include a 
discussion of scientific challenges related to:
     Diagnosis of the condition for clinical trials and in 
clinical practice and
     ensuring valid patient-reported outcome measures for the 
key efficacy endpoints used in clinical trials.

B. Meeting and Workshop Attendance and Participation

    If you wish to attend the Patient-Focused Drug Development meeting 
or scientific workshop, visit http://fsdpatientfocused.eventbrite.com. 
Please register for either the meeting or workshop by October 17, 2014. 
If you are unable to attend the meeting or workshop in person, you can 
register to view a live Webcast. You will be asked to indicate in your 
registration whether 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 meetings will be based on space availability. If you need 
special accommodations because of disability, please contact Pujita 
Vaidya or Charlene Williamson (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 during the October 27 meeting must indicate 
in their registration which topic(s) they wish to address. These 
patients also must send a brief summary of responses to the topic 
questions by October 3, 2014, to [email protected]. 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.
    FDA will hold an open public comment period during the October 27 
meeting and the October 28 workshop to give the public an opportunity 
to comment. Registration for open public comment will occur at the 
registration desk on the day of the meeting and workshop on a first-
come, first-serve basis.

III. Comments

    Regardless of attendance at the Patient-Focused Drug Development 
meeting, you can submit electronic or written comments, including 
responses to the questions pertaining to Topics 1 and 2, to the public 
docket (see ADDRESSES) by December 29, 2014. Please indicate whether 
the comments are relevant to the October 27 meeting or the October 28 
workshop. 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/Drugs/NewsEvents/ucm401167.htm.

    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22983 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P