Healing Our De-Commissioned FDA

Kesselheim AS, Avorn J - Health Affairs Forefront

  • Regulation and Clinical Evidence

Summary:

Marty Makary’s tenure as FDA Commissioner undercut the principles that made the agency a leading public health institution—sidelining external peer review, enabling scientifically indefensible decisions, and introducing an opaque super-fast-track voucher program—leaving the FDA weaker and less trusted than at any point in 50 years. The next commissioner should be chosen for scientific competence rather than ideology and return the agency to evidence-based decision making, transparency, and public accountability, particularly ahead of the looming user-fee reauthorization.

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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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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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Avorn J - MedPage Today

  • Regulation and Clinical Evidence