Broader Scientific Topics for Advisory Panels: Bumpus
FDA is looking to revamp its advisory committees to convene panels to solicit input and discuss issues involving broader scientific topics than the current typical meeting that involves product marketing applications. Speaking at an Alliance for a Stronger FDA online update, FDA chief scientist Namandjé Bumpus said her office is currently thinking through the types of topics for which committees could be utilized.
Revamping the advisory committee process is a top priority for FDA commissioner Robert Califf. Earlier this year, he told the Food and Drug Law Institute that FDA needs to “strengthen our structures, methods, data collection and science to allow us to be even more efficient, flexible and effective in the exercise of our regulatory responsibilities.” One example Califf offered is the evolving role of advisory committees as an important tool for obtaining independent advice regarding scientific, technical or policy questions. “I believe strongly in the value of interchange among our experts at the FDA and the experts who work outside the agency,” he said. “For certain complex issues, seeking the advice of an advisory committee not only makes our decisions better, but also adds an element of transparent societal discussion that’s important. But I also believe that our advisory committee system can be improved to enable our experts to get the best advice possible.”
Bumpus told the Alliance that there are also ways to leverage advisory committees around some of the broader scientific questions, such as designing clinical trials and other cross-cutting scientific and emerging science areas. “So it's really about how we ensure we get the best advice,” she said, adding that leveraging advisory committees in the most effective and meaningful way to robustly address the types of topics beyond those that would necessitate a vote is what her office is looking at.
FDA is also looking to improve the expertise that is needed for certain topics and to streamline the process to bring them onboard to participate on a panel, according to Bumpus. She said the process cannot be cumbersome because they are busy people. “So a lot of the work is really inward-looking at our processes, and trying to see how we can make them the most effective and just relieve any type of extra effort that we might be asking from advisory committees members, at least from a logistical standpoint.”
Asked whether advisory committee meetings would be transitioning back to in-person get-togethers, Bumpus said that for now the agency is content with its hybrid virtual meetings. “We do need flexibility,” she said, adding that there is a wider talent pool if the experts can attend a panel meeting virtually. “So, I think from the kind of diversity, equity inclusivity space that an online component certainly gives the opportunity for more people to participate, but there also is value from in-person interactions as well. So, we'll see different formats, I think, for different meetings. It’s really going to depend on the meeting and what works logistically.”