In less than 2 months, on May 11th, the FDA is holding 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.
Even if you cannot attend, you can make your voice heard! You can join the meeting via webcast by registering Here.
In addition, you can submit formal comments by going HERE. Click on the green button SUBMIT A FORMAL COMMENT to provide your answers to the questions listed below. This is something EVERYONE can do to help the FDA gather the information they need.
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
Have you received a diagnosis of a functional GI disorder from a health care provider? If so, please state the condition.
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)
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)
How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
How has your condition and its symptoms changed over time?
Do your symptoms come and go or are they ongoing? If so, do you know of anything that worsens your symptoms?
What worries you most about your condition?
Topic 2: Patients’ Perspectives on Current Approaches To Treating Functional GI Disorders
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.)
What specific symptoms do your treatments address?
How has your treatment regimen changed over time, and why?
How well does your current treatment regimen treat the most significant symptoms of your disease
How well do these treatments stop or slow the progression of your condition?
How well do these therapies improve your ability to do specific activities that are important to you in your daily life?
How well have these treatments worked for you as your condition has changed over time?
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.)
Assuming there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?