Building Public Trust in Scientific Decision Making through Expert Advisory Committees

Using the Food and Drug Administration (FDA) as a case study, this report evaluates the use of advisory committees by expert scientific regulatory agencies.

A group of professionals sits around a large conference table, attentively watching a presenter who points to a digital screen. The background features scientific visuals, including laboratory glassware and molecular structures, set against a blue, high-tech interface. The scene conveys innovation and collaboration in a modern corporate environment. The group includes both men and women of diverse ages, dressed in business attire.

By

C. Joseph Ross Daval

Research Fellow, Program on Regulation, Therapeutics, and Law

Brigham & Women’s Hospital and Harvard Medical School jrdaval@gmail.com

Aaron S. Kesselheim

Professor of Medicine

Harvard Medical School akesselheim@partners.org

When faced with difficult decisions about new drugs or medical devices, the Food and Drug Administration (FDA) is authorized to consult with advisory committees of independent experts. Advisory committees provide critical scientific insights and credibility for FDA efficacy and safety determinations.

Leveraging data on the frequency, outcomes, and deliberative process of FDA advisory committees, this new report describes the impact of expert advisory committees on FDA decision making. The research discussed the roles that expert advisors play in this essential public health agency, and the report makes evidence-based recommendations that policymakers can implement to make advisory committees optimally useful for the FDA. The FDA case serves as a framework for recommendations about how other expert agencies can best engage with expert independent advisory committees.

We hope that this report helps leaders in science-focused agencies to leverage expert advice in a way that informs and improves decision making.

Building Public Trust in Scientific Decision Making