Op-Ed: The Trump Administration Is Turning Drug Review Into Make-A-Deal

Carpenter D, Hwang TJ, Kesselheim AS - STAT

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The FDA’s new National Priority Voucher program replaces science-based drug review with deal-making and political bargaining. Vouchers are awarded based on vague “national health priorities” and private negotiations, rather than clear, evidence-based criteria. This approach risks corruption, undermines transparency, and could harm public trust in the FDA.

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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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