Date & Time: October 27, 2014 (Patient-Focused Drug Development Meeting) from 12:00PM-5:00PM (EST)
October 28, 2014 (Scientific Workshop) from 8:00AM-5:00PM (EST)
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
FDA is conducting a Patient-Focused Drug Development public meeting and scientific workshop on Female Sexual Dysfunction on October 27 and October 28.
On October 27, FDA is interested in obtaining patient input on the most common female sexual dysfunction, female sexual interest/arousal disorder (FSIAD), signs, symptoms, and daily impacts that matter most to patients (topic 1), and current available approaches to treat FSIAD (topic 2). The questions for discussion on these topics are below.
For each of these topics, a panel of patients and patient representatives/advocates will present comments to begin the dialogue and will be followed by a facilitated discussion inviting comments from all patients and patient representatives in the audience.
If you are interested in providing comments as part of the initial panel discussion, indicate so during the registration process. Panelists will be confirmed prior to the meeting.
Webcast participants will also have an opportunity to provide input through webcast comments.
On October 28, the scientific workshop will include a discussion of scientific challenges related to: 1) Diagnosis of the condution for clinical trials and in clinical practice, and 2) Ensuring valid patient-reported outcome measures for the key efficacy endpoints used in clinical trials.
If you are unable to attend the meeting in person, a webcast will be availlable.
There will also be an opportunity for patients, patient representatives and others to provide comments during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting.
For more information, refer to the FDA meeting website at: http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.
Questions for Discussion at October 27 Patient-Focused Drug Development Meeting
Topic 1: Disease symptoms and daily impacts that matter most to patients
1) Have you ever received a diagnosis from a healthcare provider of sexual interest/arousal disorder, hypoactive sexual desire disorder, or sexual arousal disorder?
a) 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?
2) Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life? Please describe each symptom in detail, including how this symptom specifically affects your sexual experiences.
3) 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:
a) Which symptoms vary the most, and in what ways?
b) How do your symptoms and their negative impacts on your sexual experiences compare between your “best days” and your “worst days”?
c) Do the changes in your symptoms typically happen over a period of minutes, hours, days, weeks, or months?
d) 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?
4) 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.
5) Overall, have you experienced your condition and its symptoms getting progressively worse, improving, or remaining stable over the past few years?
6) What worries you most about your condition?
Topic 2: Patient perspectives on current approaches to treat FSIAD
1) 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.)
2) How well do your current treatments specifically treat the most significant symptoms of your condition?
3) How well have your treatments improved your sexual experience?
4) How has your treatment regimen changed over time, and why?
5) Are there any downsides to the treatments you have used? (Examples of downsides may include bothersome side effects, difficulty identifying appropriate healthcare providers, etc.)
6) 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?