Efficacy of the Priority Review Voucher Program (Reply)

Sarpatwari A, Kesselheim AS - JAMA

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The authors argue that the priority review voucher program is not a sensible way to incentivize tropical disease drug development because it disrupts the FDA’s calibrated review process, risks wasting public funds by accelerating reimbursement of potentially noninnovative drugs by government insurance programs, and is easily gamed. Instead, greater NIH funding should be directed toward translational tropical disease research.

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Recent Work from PORTAL

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How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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
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Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”

Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)

  • Regulation and Clinical Evidence