Editor’s note: The attached comment letter was submitted to the Food and Drug Administration on Aug. 13, 2024.
Senior Scholar Genevieve Kanter responded to FDA’s request for comment on “Optimizing the Food and Drug Administration’s Use of and Processes for Advisory Committees.” Her comments addressed:
Composition of Advisory Committee Members: Advisory committee members should be selected with an eye to including individuals who can assist in answering difficult questions about how to analyze “hard cases.”
Financial Conflicts: To enhance public trust in the FDA, the agency should publicly disclose section 502 “appearance-of-conflict” waivers along with its disclosure of section 208 waivers prior to each meeting. As an alternative, the agency could create a nonvoting role for individuals with these waivers to provide testimony or advice on specific issues.
Perception and Understanding of Role: The public incorrectly perceives advisory committee discussions to be the sole basis for product decisions, and even media reporting occasionally confuses advisory committee recommendations with agency decisions. The FDA should consider changes to how and when advisory committee members assess applications.
