FDA Proposes Selection Process for Patient Reps

ROCKVILLE, Md--The FDA has proposed a formal process for selecting patientrepresentatives to serve on its cancer-related advisory boards--the Onco-logicDrugs 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 Initiativeon Reinventing the Regulation of Cancer Drugs, released on March 29, 1996.

In the Jan. 15, 1997, Federal Register, the FDA outlined its proposedsystem to recruit, assess, select, and train the patient representatives,who will have full voting authority when the committees make recommendationsto the agency.

"The primary role of the patient representative would be to provideto the advisory committee the perspective of the patient with the diseasefor which the therapeutic agent is being considered," the FDA said.It set seven qualifications that potential patient representatives mustmeet:

• 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 committeemeeting 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.