Tuesday, March 24, 2015

FDA Drug Development Meeting for Functional GI Disorders

This is not really a blog entry.  This is important information regarding how to attend the upcoming FDA meeting and/or submit answers to the questionnaire provided.  Please consider joining.  Be heard!


FDA Patient-Focused Drug Development for Functional Gastrointestinal Disorders Public Meeting

Many of you are already aware that the FDA will be holding a public panel discussion in which gastroparesis patient concerns will be addressed.  This is your chance to be heard by an agency that matters and can greatly affect your current and future treatment options.  They are asking to hear from you, and that is very good news!  Please don’t let this opportunity pass you by.  We do not know when another one will come around, and we need to be heard.  The FDA has almost total control over which medications and treatments will be deemed appropriate for use.  They need to know how we are affected by this cruel disease so that they will not be inclined to dismiss us and our potential treatments lightly.  They need to hear how we struggle and finally see that we are an underserved population.  This could not only sway the approval of medications and treatments, but could also open their eyes to our need for additional research and funding.  If the FDA sees our need, it could advocate for better research and accelerate the approval process for new medications and treatments.

You can attend in person, or you can register for a live webcast of this event at (http://www.eventbrite.com/e/functional-gi-disorders-patient-focused-drug-development-public-meeting-registration-15203090854).  According to the event organizer, once you have registered, “as a web participant, you will receive a link a few days before the meeting with instructions on how to log in on the day of the meeting. Once the meeting begins and web participants are logged in, they will be able to view the meeting and presentation slides via a live video feed. They will also be prompted to answer polling questions, submit text comments, and respond to discussion questions throughout the meeting simultaneously with in-person attendees.”

IF YOU CANNOT ATTEND IN PERSON, I would urge you not only to view the webcast, but also to submit your responses to the questions which will be addressed by the panel.  You can submit your comments by going to this link:   

Click on the green button labeled “Submit a Formal Comment.”  You can type in the box that opens up, and you can attach files.  Per the FDA event organizer’s response to my question about participating in this process: “Online public docket: This docket will be open from now until 2 months after the meeting takes place. Here, patients and other stakeholders can submit any comments related to the meeting, and we would be particularly interested in patient responses to the discussion questions posted.” 

The discussion questions can be found on the registration page at http://www.eventbrite.com/e/functional-gi-disorders-patient-focused-drug-development-public-meeting-registration-15203090854.  They mainly require you to discuss the physical and mental impact gastroparesis has had on your daily life as well as your opinions regarding current treatments.  You can choose to answer either the first set of questions (impact on daily life), the second set of questions (perspective on current treatments), or both.  You may submit additional information as well.  Per the FDA site, the 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).” 

According to the event organizer, “All input provided by patients and representatives via the above methods will be considered by FDA along with the comments provided by in-person participants. Comments will then be summarized into our final ‘Voice of the Patient’ summary report and posted on our meeting website (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm430885.htm) along with a full recording of the webcast and a transcript of the meeting.”

I urge you to strongly consider viewing this webcast and submitting your answers to these questions.