
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73774-73776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29992]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4166]


Public Meeting on Patient-Focused Drug Development for Psoriasis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting and an opportunity for public comment 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, including on daily life and patient views on treatment 
approaches. FDA is interested in patients' perspectives for the types 
of psoriasis with primarily skin symptoms (such plaque psoriasis, nail 
psoriasis, guttate psoriasis, etc.), patient views on treatment 
approaches, and decision factors taken into account when selecting a 
treatment.

DATES: The public meeting will be held on March 17, 2016, from 10 a.m. 
to 6 p.m. Registration to attend the meeting must be received by March 
10, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit 
electronic or written comments to the public docket by May 17, 2016.

ADDRESSES: You may submit comments as follows:

[[Page 73775]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0418 for ``An Evaluation of the Prescription Drug User Fee 
Act Workload Adjuster; Request for Comments.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    FDA will post the agenda approximately 5 days before the meeting 
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX: 301-847-8443, Meghana.Chalasani@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background on Patient-Focused Drug Development

    FDA has selected psoriasis as the focus of a public meeting under 
Patient-Focused Drug Development, an initiative that involves obtaining 
a better understanding of patient perspectives on the severity of a 
disease and the available therapies for that condition. Patient-Focused 
Drug Development is being conducted to fulfill FDA performance 
commitments that are part of the reauthorization of the PDUFA under 
Title I of the Food and Drug Administration Safety and Innovation Act 
(FDASIA) (Pub. L. 112-144). The full set of performance commitments is 
available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on at least 20 
disease areas during the course of PDUFA V. For each disease area, the 
Agency is conducting a public meeting to discuss the disease and its 
impact on patients' daily lives, the types of treatment benefit that 
matter most to patients, and patients' perspectives on the adequacy of 
the available therapies. These meetings will include participation of 
FDA review divisions, the relevant patient communities, and other 
interested stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register 
(78 FR 08441) announcing the disease areas for meetings in fiscal years 
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame. 
The Agency used several criteria outlined in that notice to develop the 
list of disease areas. FDA obtained public comment on the Agency's 
proposed criteria and potential disease areas through a public docket 
and a public meeting that was convened on October 25, 2012. In 
selecting the set of disease areas, FDA carefully considered the public 
comments received and the perspectives of review divisions at FDA. FDA 
initiated a second public process for determining the disease areas for 
FY 2016-2017, and published a notice in the Federal Register on July 2, 
2015, announcing the selection of eight disease areas. More 
information, including the list of disease areas and a general schedule 
of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain 
patient and patient stakeholder input on the symptoms of psoriasis that 
matter most to patients and on current approaches to treating 
psoriasis. Psoriasis is a chronic, immune-mediated skin condition that 
is associated with both a physical and psychological burden. It is 
characterized by areas of red, thickened, scaling skin and may be 
accompanied by itching or soreness. While there is currently no cure, 
treatments for psoriasis include topical therapies such as 
corticosteroids

[[Page 73776]]

and vitamin D analogs, systemic drugs, biologic products, and 
phototherapy. FDA is interested in the perspectives of patients with 
psoriasis on (1) the impact of their skin disease, including the extent 
and location (e.g., nail, palm, scalp, genital) of involvement, (2) 
treatment approaches, and (3) decision factors taken into account when 
selecting a treatment.
    The questions that will be asked of patients and patient 
stakeholders at the meeting are listed in this section, organized by 
topic. For each topic, a brief initial patient panel discussion will 
begin the dialogue. This will be followed by a facilitated discussion 
inviting comments from other patient and patient stakeholder 
participants. In addition to input generated through this public 
meeting, FDA is interested in receiving patient input addressing these 
questions through written comments, which can be submitted to the 
public docket (see ADDRESSES).
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 one to three 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.)

B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://psoriasispfdd.eventbrite.com. Please register by March 10, 2016. If you 
are unable to attend the meeting in person, you can register to view a 
live Webcast of the meeting. You will be asked to indicate in your 
registration if you plan to attend in person or via the Webcast. 
Seating will be limited, so early registration is recommended. 
Registration is free and will be on a first-come, first-served basis. 
However, FDA may limit the number of participants from each 
organization based on space limitations. Registrants will receive 
confirmation once they have been accepted. Onsite registration on the 
day of the meeting will be based on space availability. If you need 
special accommodations because of a disability, please contact Meghana 
Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before 
the meeting.
    Patients who are interested in presenting comments as part of the 
initial panel discussions will be asked to indicate in their 
registration which topic(s) they wish to address. These patients also 
must send to PatientFocused@fda.hhs.gov a brief summary of responses to 
the topic questions by February 29, 2016. Panelists will be notified of 
their selection approximately 7 days before the public meeting. We will 
try to accommodate all patients and patient stakeholders who wish to 
speak, either through the panel discussion or audience participation; 
however, the duration of comments may be limited by time constraints.
    Docket Comments: Regardless of whether you attend the public 
meeting, you can submit electronic or written responses to the 
questions pertaining to Topics 1 and 2 to the public docket (see 
ADDRESSES) by May 17, 2016.
    Transcripts: As soon as a transcript is available, FDA will post it 
at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

    Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29992 Filed 11-24-15; 8:45 am]
BILLING CODE 4164-01-P


