The United States Food and Drug Administration (FDA) recently announced a planned listening session on June 13, 2024, as part of its process of optimizing advisory committees. The session will focus on the composition of advisory committees, how to improve the experience for members that serve on committees, and how to improve public awareness and understanding of the role of FDA advisory committees.
Advisory committees advise the FDA on a variety of topics, including the development, use, and evaluation of drugs, biological products, and medical devices. They are often made up of experts in technical, scientific, public health, and medical fields, with additional participants from industry and consumer organizations as well as patients. The opinions issued by advisory committees are non-binding on the FDA, as the final decisions are made by the agency.
During the listening session, FDA is specifically looking for input on how the agency can better incorporate diverse perspectives and experiences in addition to patient and consumer opinions, as well as feedback on how to streamline administrative burdens that may make it less likely for individuals to want to serve on an advisory committee.
The FDA is reviewing advisory committee policies and practices to better optimize, including working to modernize systems to reduce paperwork and streamline processes; improve the utility of advice received from advisory committees; increase recruitment of committee members; standardize practices and procedures across the agency; and improve public understanding of the committees and the role they play in the FDA.
“The FDA regulates products that impact the everyday lives of the American people, and advisory committees play a key role in that process. It’s important we have the right expertise, diverse viewpoints and other processes in place to ensure the agency gets timely and sound advice,” said FDA Commissioner Robert M. Califf, M.D. “We are hopeful this listening session will provide valuable feedback on optimizing the advisory committees’ role in the agency’s science-based decisions and its mission in protecting and promoting public health.”
“Although all decisions are made by FDA staff, the discussions that take place at advisory committee meetings are important pieces that are considered as part of the FDA’s decision-making,” said FDA Principal Deputy Commissioner Namandjé Bumpus, Ph.D. “Gathering broad feedback on the advisory committee process and how these committees inform agency decisions in an open and transparent platform will inform our work to further enhance how the FDA uses the input of our external experts.”
The listening session will take place from 9 AM to 4 PM ET on June 13, 2024. While the public may make oral or written comments, the FDA encourages commenters to include any available supporting data and information. To make an oral presentation during the session, you must register no later than 3 PM ET on May 13, 2024. The FDA may limit the number of participants from each organization, depending on the total number of participants. Priority will be given to early registrants. To register for the meeting, click here. Electronic comments must be submitted to the regulations.gov electronic filing system no later than August 13, 2024.