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Using a Drug-Safety Tool to Prevent Competition

Sarpatwari A, Avorn J, Kesselheim AS - New England Journal of Medicine

  • Commentary & Opinion
| April 2014
  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The authors document how some brand-name manufacturers have exploited FDA REMS requirements to block generic competition by refusing to provide drug samples for bioequivalence testing and hindering development of shared REMS programs.

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How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Commentary & Opinion
| October 2026
  • 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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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

  • Research Publications
| October 2026
  • Price, Value, and Access
  • Regulation and Clinical Evidence
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The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Commentary & Opinion
| October 2026
  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
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