Characteristics of Speakers at US FDA Advisory Committee Meetings on Drug Approval

Rand LZG, Mooney H, Hong D, Eisenkraft Klein D, Kesselheim AS, Rome BN - JAMA Internal Medicine

  • Regulation and Clinical Evidence

Summary:

During the 161 FDA advisory committee meetings held from 2015 to 2023, patients and family members made up nearly half of all speakers during public comment periods. 82% of speakers supported drug approval, and speakers reporting conflicts of interest (COI) were 11% more likely to favor approval. These findings highlight the need for COI disclosure and broader stakeholder input at these committee meetings.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
Talk bubble graphics representing commentary and opinion.

Politics and the Patient Encounter, in Dire Times

Avorn J - MedPage Today

  • Regulation and Clinical Evidence