Pharmacoepidemiology and the Law

Kesselheim AS - Pharmacoepidemiology, 5th Edition

  • Regulation and Clinical Evidence

Summary:

This textbook chapter outlines 3 critical intersections of pharmacoepidemiology and the law—tort law (where product liability lawsuits seek damages from drug manufacturers, with pharmacoepidemiologists often serving as expert witnesses), contract law (governing sponsored research agreements with implications for data access and publication rights), and intellectual property law (where patents may secure ownership of discoveries but can also raise research costs and hinder collaboration).

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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
Talk bubble graphics representing commentary and opinion.

Politics and the Patient Encounter, in Dire Times

Avorn J - MedPage Today

  • Regulation and Clinical Evidence