Date: March 17, 2016
Time: 10:00 a.m. to 4:00 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 March 17, 2016 FDA is conducting a public meeting on Patient-Focused Drug Development for Psoriasis. 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 psoriasis on daily life, patient views on treatment approaches, and decision factors taken into account when selecting a treatment. FDA is interested in patient's perspectives for the types of psoriasis with primarily skin symptoms (such as plaque psoriasis, nail psoriasis, guttate psoriasis, etc.),
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/ucm470608.htm
Topic 1: Disease symptoms and daily impacts that matter most to patients
1) 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 red, thickened, scaling skin, itching, burning or soreness, 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 sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
3) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
4) How have your condition and its symptoms changed over time?
a) Would you define your condition today as being well managed?
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 condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, phototherapy, and other therapies including non-drug therapies such as diet modification.)
a) How has your treatment regimen changed over time, and why?
2) How well does your current treatment regimen control your condition?
a) How well do your treatments address specific skin symptoms? Which symptoms are not addressed as well?
b) 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 going to the hospital or clinic for treatment, time devoted to treatment, 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?
a) What would you consider to be a meaningful improvement (for example symptom improvements or functional improvements) in your condition that a treatment could provide?
5) What factors do you take into account when making decisions about selecting a course of treatment?
a) What information on the potential benefits of these treatments factors most into your decision?
b) How do you weigh the potential benefits of these treatments versus the common side effects of the treatments? (Common side effects could include headache, nausea, injection site reactions)
c) How do you weigh potential benefits of these treatments versus the less common but serious risks associated with the treatments? (Examples of less common but serious risks are infections, cancer, liver damage, kidney damage, birth defects, blood disorders, etc.)