FDA opens discussion on optimizing advisory committees to the public

In June, the United States FDA will host a listening session on FDA advisory committees, encouraging public engagement as a part of broader efforts to optimize the use of and process for these committees, which play a critical role in reviewing FDA-approved products and providing recommendations. The meeting will be held virtually and will include topics on comprising advisory committees, improving member experiences, and ensuring public awareness.

“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, MD, in the press release. “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.”

In the biopharmaceutical landscape, FDA advisory committees offer critical guidance for approving or denying FDA-regulated products. Comprised of industry experts in addition to consumer, industry, and patient representatives, these committees are not responsible for final regulatory decisions; however, they offer recommendations to the FDA.

Advisory committees recently came under fire, receiving criticism when news broke that 10 of the 14 voting members on the FDA advisory panel reviewing the Abbott TriClip G4 System had received some form of financial contributions from Abbott.  

Although an FDA spokesperson and panel members maintained that all the appropriate disclosures and procedures were taken to ensure that the panel members could remain impartial, this incident opened a broader conversation about bias in the panels.

While the FDA press release does not indicate that the June meeting will address this specific concern, the administration is looking for feedback on how to incorporate diverse voices and experiences, streamline administrative burdens, and educate the public on the role of these committees.

“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, PhD, in the press announcement. “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.”

Beyond engaging the public, the FDA’s broader efforts for optimizing the advisory committees include the following efforts:

• Modernizing systems to reduce paperwork and streamline processes
• Improving the utility of advisory committee advice
• Amplifying recruitment of potential committee members
• Establishing mechanisms to share and standardize practices and procedures
• Improving public understanding of advisory committees