Ethical Issues in New Drug Prescribing

Cole LW, Kesselheim JC, Kesselheim AS - Journal of Bioethical Inquiry

  • Price, Value, and Access
  • Regulation and Clinical Evidence

Summary:

This case study examines ethical and legal considerations physicians face when prescribing newly FDA-approved drugs, highlighting the limitations of both the drug approval system and post-approval surveillance mechanisms. The authors argue that physicians have ethical obligations to seek independent information sources, report adverse effects, and inform patients about the incomplete knowledge base surrounding new therapies.

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