[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
[[Page 2167]]
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]
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