[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Pages 58848-58849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0966]


Prescription Drug User Fee Act V Patient-Focused Drug 
Development; Consultation Meetings; Request for Notification of Patient 
Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meetings; request for notification of participation.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice 
to request that patient stakeholders notify FDA of their intention to 
participate in periodic consultation meetings on process issues related 
to FDA's patient-focused drug development initiative. This initiative 
is being conducted to fulfill FDA performance commitments made as part 
of the fifth authorization of the Prescription Drug User Fee Act (PDUFA 
V). These periodic consultation meetings will address important 
considerations and challenges in establishing a process for conducting 
a series of patient-focused drug development meetings that will be 
useful to both the patient community and FDA. The purpose of this 
request for notification is to ensure continuity and progress in these 
discussions by establishing consistent patient stakeholder 
representation.

DATES: Submit notification of intention to participate in this series 
of meetings by October 3, 2012. The first stakeholder meeting on 
process issues will be held on October 10, 2012, from 2 p.m. to 3:30 
p.m. These discussions will continue on an approximately bimonthly 
basis as needed during PDUFA V.

ADDRESSES: Submit notification of intention to participate in this 
series of meetings by email to [email protected]. The first 
meeting with patient stakeholders will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 51, Rm. 1300, Silver Spring, MD 
20993-0002. Entrance for the consultation meetings' participants (non-
FDA employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Andrea Tan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave. 
Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-796-7641, FAX: 
301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the President signed into law the Food and Drug 
Administration Safety and Innovation Act of 2012 (FDASIA). Title I of 
FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA) that 
provides FDA with the necessary user fee resources to maintain a 
predictable and efficient review process for human drug and biologic 
products. The reauthorization of PDUFA includes performance goals and 
procedures that represent FDA's commitments during fiscal years 2013-
2017. These commitments are referred to in section 101 of FDASIA and 
are available on the FDA Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    Section X of these commitments relates to enhancing benefit-risk 
assessments in regulatory

[[Page 58849]]

decisionmaking. A key part of regulatory decisionmaking is establishing 
the context in which the particular decision is made. In drug 
regulation, this context includes a thorough understanding of the 
severity of the treated condition and the adequacy of the existing 
treatment options. Patients who live with a disease have a direct stake 
in the outcome of the review process and are in a unique position to 
contribute to weighing benefit-risk considerations that can occur 
throughout the medical product development process. Though several 
programs exist to facilitate patient representation, there are 
currently few venues in which the patient perspective is discussed 
outside of a specific product's marketing application review. The human 
drug and biologic review process could benefit from a more systematic 
and expansive approach to obtaining input from patients who are 
experiencing a particular disease or condition.
    FDA is committed to obtaining input from patients and, as set out 
in the commitment letter, will conduct public meetings to consider 20 
different disease areas over the 5-year authorization of the program. 
For each disease area, FDA will conduct a public meeting to discuss 
such topics as the impact of the disease on patients, the spectrum of 
severity for those who have the disease, the measures of benefit that 
matter most to patients, and the adequacy of the existing treatment 
options for patients. In a separate notice published elsewhere in this 
issue of the Federal Register, FDA is seeking comment on a proposed 
list of disease areas for consideration at these meetings.
    FDA recognizes that there is significant interest in patient-
focused drug development within the patient community. To ensure that 
patient stakeholders have an additional opportunity to engage in a 
discussion of key process considerations as this initiative moves 
forward in PDUFA V, FDA is convening a series of periodic consultation 
meetings with patient stakeholders to address key process questions for 
patient-focused drug development. These periodic consultation meetings 
will be separate from the disease-specific public meetings that are 
part of FDA's commitments in PDUFA V; however, the process consultation 
discussions may help inform the best strategies for conducting future 
disease-specific meetings. FDA anticipates that the periodic 
consultation meetings will be focused on process questions for 
consideration by FDA and patient stakeholders. Examples of potential 
process topics include the following:
    1. Given the limits of FDA staff resources and time available, how 
to prioritize and balance different disease areas identified by 
different patient stakeholders.
    2. How to approach issues when patient stakeholders for the same 
disease area have different and potentially conflicting views.
    3. How to balance access to FDA for patient stakeholders who are 
local to FDA headquarters versus those in other locations who have less 
physical access.
    4. How to support engagement of patients in disease areas for which 
no formal advocacy organizations exist. What role, if any, might 
already organized groups play?
    Patient stakeholders provided critical input in the development of 
the patient-focused drug development proposal during the PDUFA V 
discussions. FDA expects that there will be continued interest among 
patient stakeholders as this PDUFA V enhancement is implemented. FDA is 
publishing this Federal Register notice to request that patient 
stakeholders notify the Agency of their intention to participate in 
this series of process consultation meetings on patient-focused drug 
development. FDA believes that consistent patient stakeholder 
representation at these meetings will be important for ensuring 
progress in these discussions.

II. Notification of Intention To Participate in Periodic Consultation 
Meetings

    If you are an individual patient stakeholder who intends to 
participate in periodic consultation meetings regarding FDA's 
implementation of the patient-focused drug development initiative, 
please provide notification by email to [email protected] by 
October 3, 2012. If you represent an organization that intends to 
participate in these meetings, please designate one or more 
representatives from your organization who will commit to attending 
these meetings and preparing for the discussions as needed and provide 
notification by email to [email protected] by October 3, 2012. 
All notification emails should contain complete contact information, 
including name, title, affiliation, address, email address, phone 
number, and notice of any special accommodations required because of 
disability. Seating will be limited, so early notification is 
encouraged. FDA may limit the number of participants from each 
organization based on space limitations. Patient stakeholders will 
receive confirmation and additional information about the first meeting 
once FDA receives their notification and will be included in future 
communications from FDA about implementing patient-focused drug 
development. If stakeholders decide to participate at a later time, 
they may notify FDA of their intent to participate in future meetings 
as described previously in this document (see ADDRESSES). FDA intends 
to post summary meeting minutes on its Web site after each meeting has 
concluded.

    Dated: September 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23453 Filed 9-21-12; 8:45 am]
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