FDA Discusses Optimizing Advisory Committees

FDA is outlining areas it feels can be optimized to help improve the advice received from advisory committee meetings. Writing in the 9/30 journal Nature, FDA commissioner Robert Califf and other top officials say they plan to refine the areas through future public engagements.

One of the top focus areas for optimizing advisory> committees (ACs) is to “explore how to improve the utility of the advice the FDA receives from ACs, including by evaluating the composition of existing committees and considering how to best solicit useful feedback from committees,” according to the agency officials. Other focus areas are:

• Modernize systems to reduce paperwork burden and streamline processes, including updated forms for expedited digital signature and processing and exploring system improvements for SGE [special government employee] onboarding and internal processes.
• Improve recruitment of SGEs, possibly by increasing dedicated staff and engaging existing committee members.
• Share and standardize certain practices and procedures across the agency and ensure that internal resources are up-to-date .
• Improve public understanding of ACs and the role they have, including through external communications and publications.
• Obtain input on FDA use of ACs from all interested parties through a public listening session and public comments.

In their article, Califf et al note that voting should not be a mandatory part of AC meetings, and is not beneficial at meetings discussing general issues, such as clinical trial designs or guidance documents. “At other AC meetings, members may cast formal votes on particular issues, such as whether benefits outweigh risks in a product submission," they write. “The feedback the FDA obtains from votes on discrete questions can help the agency gauge a committee’s collective view on complex issues. However, many of the issues considered by ACs are nuanced, and FDA staff may be primarily interested in the discussions and interpretation of particular aspects of the data rather than in a summative conclusion regarding risks and benefits.”

They note that agency staff are the ones that determine whether and when to pose specific questions to an AC, either for a vote on a discrete issue or a more general discussion, depending on the subject of the meeting and the advice the FDA is seeking. “A committee’s final vote often receives more attention outside the FDA than the discussion itself, possibly contributing to a misperception that AC votes are decisional,” they contend, adding that staff always consider input from the AC, but final decisions are made by FDA.