The U.S. FDA is planning to hold an advisory committee meeting on…well, advisory committee meetings.
After months of signaling coming change to the advisory committee meetings that provide advice to the agency when considering the approval of certain drugs, the FDA is now slated to host a public hearing on the matter in June.
The agency will specifically solicit feedback on the composition of the meetings, how to improve the experience for members on the committees and ways to facilitate public understanding of the committees.
“It’s important we have the right expertise, diverse viewpoints and other processes in place to ensure the agency gets timely and sound advice,” FDA Commissioner Robert Califf, M.D., said in a Monday statement. “We are hopeful this listening session will provide valuable feedback on optimizing the advisory committee’s role in the agency’s science-based decisions and its mission in protecting and promoting public health.”
Advisory committees provide nonbinding advice to the FDA on key questions related to a drug’s potential approval. They are not used for every application, but the FDA can opt to hold the day-long public session to answer key questions related to an application. The agency does not have to agree with the committee's vote but historically approval decisions typically fall in line with what the panel recommends.
For instance, the agency just opted to convene the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s new Alzheimer’s disease medicine donanemab. That committee reviews all matters relating to neurologic diseases.
Califf has previously signaled a desire to get rid of the vote that comes at the end of a long day of discussion at advisory committee meetings—a point one of his deputies, Richard Pazdur, M.D., director of the Oncology Center of Excellence, disagrees with.
“Many of the people that are arguing for not having this voting question have not been in the review division,” Pazdur said at the American Association for Cancer Research Oncology Industry Partnering Event earlier this month. “Having sat through 25 years of these meetings, I do not know before the vote occurs what is going to happen here … We need that clarity—we have to make a decision.”
The FDA is currently working through a review of advisory committee processes, including modernizing systems to reduce paperwork, improving the utilization of advice received from the committees, amplifying recruitment for membership and improving public understanding.
“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,” said Namandjé Bumpus, Ph.D., FDA principal deputy commissioner, in an April 29 statement.
The listening session will take place June 13 from 9 a.m. to 4 p.m. ET.