On Aril 29, the U.S. Food and Drug Administration (FDA) announced via a press release it will host a “listening session” in June as part of its work to optimize the use of, and processes for, advisory committees. The virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees and ways to ensure public awareness and understanding of the role of FDA advisory committees.
The press release says that “Advisory committees are typically made up of technical, scientific, public health and medical experts, as well as representatives of industry, consumer organizations and patients. They provide the FDA with independent advice on many topics, including the development, use and evaluation of drugs, biological products, medical devices and tobacco products, as well as broader scientific, medical and public health topics. Advisory committees provide non-binding recommendations to the agency, and final decisions are made by the FDA.”
Further, “For the listening session, the agency is 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 wants feedback on how it could streamline any administrative burdens (e.g., the amount of onboarding paperwork and processing time) that may make it less likely for an individual to want to serve on a committee. Additionally, the agency is interested in hearing about how it could improve the public’s awareness and understanding of the role of FDA advisory committees. For example, the FDA is seeking input on if it could update any processes on advisory committee discussion and/or voting that would clarify any misconception that advisory committee votes are binding on the agency’s final decision rather than recommendations that are only one of several factors considered in the FDA’s decisions.”
Efforts the FDA is taking to consider how advisory committee policies and practices can be improved include:
- Initiatives to modernize systems to reduce paperwork burden and streamline processes
- Exploring ways to improve the utility of advice received from advisory committees
- Considering ways to amplify recruitment of potential committee members,
- Establishing mechanisms to share and standardize certain practices and procedures across the agency
- Working to improve public understanding of advisory committees and the roles they play
The agency will hold the virtual listening session on June 13 from 9 a.m. to 4 p.m.
