Op-Ed: Superbugs Call for Super Changes in Drug-Sale Rules

Kesselheim AS, Outterson K - Boston Globe

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The traditional pharmaceutical business model—which incentivizes companies to maximize antibiotic sales before patents expire—accelerates the development of drug-resistant infections. The authors propose restructuring antibiotic economics by pricing new antibiotics higher to reflect their true societal value, but conditioning continued marketing exclusivity on meeting government-set conservation and resistance targets, thereby aligning manufacturers’ financial incentives with public health goals of antibiotic stewardship. They also advocate for a Strategic Antibiotic Reserve to preserve the most valuable new antibiotics for future use.

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How Congress Can Fix Expert Advisory Committees

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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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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Politics and the Patient Encounter, in Dire Times

Avorn J - MedPage Today

  • Regulation and Clinical Evidence