[Federal Register Volume 62, Number 10 (Wednesday, January 15, 1997)]
[Notices]
[Pages 2166-2167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0478]


Cancer-Related Advisory Committees; Proposed Process for 
Selection of Patient Representatives

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting comments 
from interested parties on the proposed process for the selection of 
patient representatives to serve on cancer-related advisory committees. 
As part of the ``FDA Initiative on Reinventing the Regulation of Cancer 
Drugs,'' the Cancer Liaison Staff in the Office of AIDS and Special 
Health Issues has been charged with developing a process for 
recruitment, assessment, and selection of patient representatives to 
serve as members of cancer-related advisory committees in the Center 
for Drug Evaluation and Research (CDER), the Center for Biologics 
Evaluation and Research (CBER), and the Center for Devices and 
Radiological Health (CDRH). This initiative is intended to provide 
representation for cancer patients and to ensure that the selection 
process will provide for broad representation in the nominee pool, and 
to develop criteria for the selection of the patient representatives. 
The criteria for both the nomination and selection process will help 
ensure that the patient representative will provide the perspective of 
the patients with the disease for which a therapeutic product is being 
considered by the advisory committee.

DATES: Written comments on the proposed process by March 17, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: JoAnn Minor, Office of AIDS and 
Special Health Issues (HF-12), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4460 or E-mail: 
JM[email protected].
SUPPLEMENTARY INFORMATION:

I. Background

    On March 29, 1996, President Clinton announced the ``FDA Initiative 
on Reinventing the Regulation of Cancer Drugs'' that will result in 
more rapid approval of cancer therapies and expanded access to 
investigational cancer therapies. This program of cancer initiatives 
also includes the participation of patient representatives on FDA 
advisory committees that review and consider cancer-related therapies. 
Advisory committees provide independent, outside expert scientific 
advice to the agency; they evaluate data concerning the safety and 
efficacy of products and make recommendations to the agency concerning 
their approval and appropriate use.
    Patient representatives can provide a unique perspective during the 
deliberations of advisory committees. The patient representatives bring 
to the committee the views on the drug or product under review from 
individuals and families directly affected by the disease. The agency 
recognizes the valuable contributions that patient representatives 
provide. During the past several years, the Antiviral Drugs Advisory 
Committee and the Blood Products Advisory Committee have included 
patient representatives at their meetings when products for the 
treatment or diagnosis of human immunodeficiency virus/acquired immune 
deficiency syndrome (HIV/AIDS) and blood safety were under discussion. 
More recently, the Oncologic Drugs Advisory Committee, the Biological 
Response Modifiers Advisory Committee, and the Medical Imaging Drugs 
Advisory Committee have begun including such representatives.
    Patients, patient advocacy groups, and others have endorsed the 
agency in its commitment to include patient representation on advisory 
committees. In the past, the medical review division and the advisory 
committee's Executive Secretary, acting upon recommendations by the 
Office of AIDS and Special Health Issues, selected patient 
representatives through an informal process. The agency believes that 
it would be useful to have a uniform system to recruit, select, and 
refer patient representatives to serve on FDA advisory committees. The 
following is a proposed process to formalize the recruitment and 
selection of patient representatives to serve on committees reviewing 
cancer-related therapies.

II. The Proposed Process

    The agency is developing a process for the recruitment, assessment, 
selection, and training of patient representatives. As part of this 
process, the agency believes that a mechanism for soliciting 
nominations of qualified patient representatives to ensure broad 
representation in the nominee pool is critical. To that end, the agency 
proposes to develop: (1) A listing of qualifications to be considered 
in

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selecting patient representatives, and (2) a plan for soliciting 
nominations.

A. Qualifications for Patient Representatives

    The agency has decided that patient representatives on FDA advisory 
committees that review and consider cancer therapies will be voting 
members. Patient representatives will be subject to the same conflict 
of interest requirements as other committee members as set out in 
Sec. 14.80 (21 CFR 14.80) and must serve as special Government 
employees. Section 14.80 defines the qualifications for voting members 
of advisory committees. FDA recognizes that in some cases the 
composition of an advisory committee is mandated by statute or 
regulation. The agency will make a determination to add a voting 
patient representative on a case-by-case basis when: (1) Meetings are 
planned; (2) FDA determines it is allowable within the statutes and 
regulations; and (3) it is feasible and beneficial to a committee's 
deliberation.
    The primary role of the patient representative would be to provide 
to the advisory committee the perspective of the patients with the 
disease for which the therapeutic agent is being considered. Currently, 
many of the FDA advisory committees, including those that provide 
advice on cancer-related issues, include a representative who is 
broadly identified with consumer interests and who has been nominated 
and recommended by a consumer-oriented organization. However, because 
there are so many different cancers, the number of appropriate 
perspectives is larger than a single consumer can represent. To more 
specifically represent the interests of the patients, the FDA believes 
that a patient representative who understands issues specific to the 
cancer for which a drug, device, or biologic approval is being sought 
would bring valuable insights to the FDA advisory committee process. 
Multiple factors are important to determine the ability of a person to 
be an effective patient representative. In addition to the 
qualifications described under Sec. 14.80, the following qualifications 
are under consideration for selecting patient representatives: (1) 
Personal experience with an illness, condition, or treatment; (2) 
experience as a patient advocate; (3) formal affiliation with a patient 
advocacy organization; (4) ability to articulate the perspective of the 
patient; (5) ability to identify issues through communications with 
patient constituencies; (6) ability to access mechanisms to disseminate 
information from an advisory committee meeting to the affected 
community; and (7) experience in technical issues before the committee.

B. Soliciting Nominations

    The agency believes that a mechanism for soliciting nominations of 
qualified patient representatives to ensure broad representation in the 
nominee pool is critical. After the qualifications for voting patient 
representatives are defined, the agency proposes to solicit nominations 
by the following methods: (1) Federal Register announcement as set out 
in 21 CFR 14.82; and possibly through Internet announcements; (2) 
direct mailings of announcements and personalized letters to patient 
advocacy groups, community organizations, and other public interest 
organizations; (3) patient newsletter announcements; or (4) display 
announcements at conferences, advisory committee meetings, workshops, 
etc. that FDA staff members attend, and at other conferences, meetings, 
and workshops.
    Nominations may be submitted by individuals, patient advocacy 
groups and organizations. Self nominations will also be acceptable.

III. Comments

    FDA is seeking the views of the public with regard to the proposed 
qualifications that should be considered in selecting a patient 
representative and comments on the adequacy of the methods proposed to 
obtain nominations. The agency will review and consider written 
comments on the approach set forth in this notice. Any comments 
received will be considered in determining whether amendments to, or 
revisions of, the approach are warranted. Two copies of any comments 
should be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in the 
brackets in the heading of this document. Comments received are 
available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 30, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-945 Filed 1-14-97; 8:45 am]
BILLING CODE 4160-01-F