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FDA Proposes Selection Process for Patient Reps

FDA Proposes Selection Process for Patient Reps

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 meet:

  1. Personal experience with a cancer.
  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. Access to ways to disseminate information from an advisory committee meeting to the affected community.
  7. Experience in the technical issues before the committee.

Nominations can be made by individuals, including self-nominations, and by patient advocacy groups and organizations.

 
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