Date: May 11, 2015
Time: 1:00 p.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
(Enter at Building 1 to clear security)
On May 11, 2015, FDA is conducting a public meeting on Functional Gastrointestinal (GI) Disorders Patient-Focused Drug Development. FDA is interested in obtaining patient input on symptoms and daily impacts that matter most to patients (topic 1), and current available approaches to treating functional GI disorders, such as irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation (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.
There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign-up for Open Public Comment will take place the day of the meeting.
Webcast participants will also have an opportunity to provide input through webcast comments.
For more information, refer to the FDA meeting website at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm430885.htm
Questions for Discussion
Topic 1: Disease symptoms and daily impacts that matter most to patients
1) Have you received a diagnosis of a functional GI disorder from a healthcare provider? If so, please state the condition.
2) 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 pain, bloating, constipation, vomiting)
3) 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)
a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
4) How has your condition and its symptoms changed over time?
a) Do your symptoms come and go or are they ongoing? If so, do you know of anything that worsens your symptoms?
5) What worries you most about your condition?
Topic 2: Patients’ perspectives on current approaches to treating functional GI disorders
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 nondrug therapies such as diet modification.)
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 stop or slow the progression of your condition?
b) How well do these therapies improve your ability to do specific activities that are important to you in your daily life?
c) 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) Assuming there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?