[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]
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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.
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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]
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