Date: June 10, 2016
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 B+C)
Silver Spring, MD 20993
(Enter at Building 1 to clear security)
On June 10, 2016 FDA is conducting a public meeting on Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy. Patient-Focused Drug Development is part of FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated with peripheral neuropathies, patient views on treatment approaches, and decision factors taken into account when selecting a treatment.
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 attending the meeting in person and are interested in providing comments as part of the initial panel discussion, indicate so during the registration process. Potential panelists must send a brief summary of responses to the discussion questions below to PatientFocused@fda.hhs.gov. 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/ucm490866.htm
Topic 1: Disease symptoms and daily impacts that matter most to patients
1) How would you describe your neuropathic pain associated with peripheral neuropathy? What terms would you use to describe the most bothersome aspects of pain? (Examples may include stabbing sensations, electric shocks, burning or tingling, 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 neuropathic pain? (Examples of activities may include sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
3) How does your neuropathic pain and its negative impacts affect your daily life on the best days? On the worst days?
4) How has your neuropathic pain changed over time?
5) What worries you most about your condition?
Topic 2: Patients’ perspectives on current approaches to treatment
1) What are you currently doing to help treat your neuropathic pain associated with peripheral neuropathy? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies).
a) How has your treatment regimen changed over time, and why?
2) How well does your current treatment regimen control your neuropathic pain?
a) How well have these treatments worked for you as your condition has changed over time?
b) Would you define your condition today as being well managed?
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 or clinic for treatment, time devoted to treatment, restrictions on driving, etc.)
4) Assuming there is no complete cure for your neuropathic pain, what specific things would you look for in an ideal treatment for your neuropathic pain?
a) What would you consider to be a meaningful improvement in your condition (for example specific symptom improvements or functional improvements) that a treatment could provide?
5) If you had the opportunity to consider participating in a clinical trial studying experimental treatments for neuropathic pain, what things would you consider when deciding whether or not to participate? (Examples may include how severe your neuropathic pain is, how well current treatments are working for you, your concern about risks, etc.)