A Message from United States Food and Drug Administration:
Dear idiopathic pulmonary fibrosis meeting attendees,
Thank you for attending the public meeting on idiopathic pulmonary fibrosis patient-focused drug development! FDA collected valuable information on the disease, the impact it has on patients’ lives, and patients’ perspectives on treatment options. We truly appreciate the courage, effort and time invested from everyone who was able to attend the meeting in person or on the web.
We know that not everyone who wanted to come to this meeting was able to attend. For anyone who missed the meeting or is interested in what was discussed, we have posted a full recording of the meeting on our website: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm395774.htm
In addition to the input we gathered at the September 26 meeting, we encourage patients, caregivers, and other stakeholders to submit written comments to the online public docket. The comment period closes on November 26, 2014. Submit your comments through this website: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0865-0001
FDA is particularly interested in hearing patients’ perspectives on the questions outlined in the Federal Register Notice that announced this meeting. These questions are pasted below for your reference, and the Federal Register Notice can be found here: http://www.gpo.gov/fdsys/pkg/FR-2014-07-08/pdf/2014-15871.pdf
Again, thank you to everyone who attended the September 26 meeting. If you have any questions, please email PatientFocused@fda.hhs.gov.
Questions for Discussion
Topic 1: Disease signs, symptoms and daily impacts that matter most to patients
1) Of all the symptoms that you experience because of the condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include shortness of breath, cough, fatigue, etc.)
2) 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 household chores, walking up the stairs, etc.)
a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
3) How has your condition and its symptoms changed over time?
Topic 2: Patient perspectives on current approaches to treating idiopathic pulmonary fibrosis
1) What are you currently doing to help treat the condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as diet modification.)
a) How well does your current treatment regimen treat the most significant symptoms of your disease?
2) 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, etc.)
3) Because there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?
Public Meeting on Idiopathic Pulmonary Fibrosis Patient-Focused Drug Development
Hosted by United States Food and Drug Administration
Friday, September 26, 2014 from 1:00 PM to 5:00 PM (EDT)
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Room 1503 B and C (Great Room), Silver Spring, MD 20993 | Directions