Improving Transparency of Drug Regulatory Decisions

Siebert M, Tibau A - BMJ

  • Regulation and Clinical Evidence

Summary:

Drug authorization is often presented as a unanimous decision, even when regulatory experts disagree about a medicine’s benefits, risks, and evidentiary uncertainties. Regulators should make scientific dissent more visible by reporting disagreements and voting outcomes. Greater transparency would help patients, clinicians, and policymakers understand regulatory uncertainty, see whether concerns are addressed over time, and strengthen public trust.

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