Flaws in the FDA’s New Priority Voucher Program

Carpenter D, Hwang TJ, Kesselheim AS - New England Journal of Medicine

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The FDA’s new Commissioner’s National Priority Voucher (CNPV) program is flawed, with broad and opaque eligibility criteria that risk politicizing drug approvals and undermining public trust. The program may have little impact on overall drug development timelines, while imposing burdens on agency staff and opening the door to conflicts of interest. The FDA should implement strong safeguards on the CNPV program to ensure transparency, fairness, and regulatory integrity.

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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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