ROCKVILLE, Md--The FDA has proposed a formal process for selecting patient
representatives to serve on its cancer-related advisory boards--the Onco-logic
Drugs Advisory Committee, the Biological Response Modifiers Advisory Committee,
and the Medical Imaging Drugs Advisory Committee.
Patient representatives are called for in President Clinton's FDA Initiative
on Reinventing the Regulation of Cancer Drugs, released on March 29, 1996.
In the Jan. 15, 1997, Federal Register, the FDA outlined its proposed
system to recruit, assess, select, and train the patient representatives,
who will have full voting authority when the committees make recommendations
to the agency.
"The primary role of the patient representative would be to provide
to the advisory committee the perspective of the patient with the disease
for which the therapeutic agent is being considered," the FDA said.
It set seven qualifications that potential patient representatives must
- Personal experience with a cancer.
- Experience as a patient advocate.
- Formal affiliation with a patient advocacy organization.
- Ability to articulate the perspective of the patient.
- Ability to identify issues through communications with patient constituencies.
- Access to ways to disseminate information from an advisory committee
meeting to the affected community.
- Experience in the technical issues before the committee.
Nominations can be made by individuals, including self-nominations,
and by patient advocacy groups and organizations.