FDA Gets Feedback at Meeting on AdComm Makeup and Processes

Over seven hours of presentations, 50 stakeholders and members of the public voiced their opinions on the FDA’s advisory committee process, focusing often on diversity as well as patient and consumer perspectives in the panels, along with improved transparency and communications.

The agency held a public listening session seeking input on whether there are ways the FDA can better incorporate a variety of diverse perspectives and experiences, as well as consumer and patient voices into advisory committee meetings. The FDA also sought feedback on how it could streamline administrative burdens that may make it less likely for a person to want to serve on a committee.

Some speakers at the meeting agreed that the FDA should provide robust training for new advisory committee members on the basics of clinical development, regulatory decision-making, clinical trials, and patient outcomes data.

Others said the role of labeling should be explained to committee members — including how it serves to explain nuance and mitigate risks, so advisory committee members understand that the FDA does not regulate clinical care.

The deadline for submitting comments is Aug. 13.

Submit comments here.

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