Strengthening FDA Expert Advice and the Use of FDA Advisory Committees

Speaker(s)

Moderator: David Howard, PhD, Emory University, Atlanta, GA, USA
Speakers: Sean Tunis, MD, MSc, Rubix Health, Baltimore, MD, USA; Joseph Ross Daval, JD, Harvard University, Washington, DC, USA; Genevieve Kanter, PhD, University of Southern California, Los Angeles, CA, USA

The FDA convenes advisory committees, which consist of external experts, to provide technical assistance in evaluating evidence for new drug and device approvals. But recent controversies surrounding these federal advisory committees—such as the FDA’s decision to approve an Alzheimer’s drug despite the negative recommendations of its advisory committee—have led the public and policymakers to question FDA’s use of its advisory committees and whether FDA advisory committees are functioning as well as they could.

This panel will discuss the role of expert advice in government decision-making, historical and emerging concerns about FDA advisory committees, and ways to improve the FDA advisory committee process.

Code

013

Topic

Health Policy & Regulatory