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Spending on postapproval drug safety.

David B Ridley1, Judith M Kramer, Hugh H Tilson

  • 1Fuqua School of Business, Duke University, Durham, North Carolina, USA. david.ridley@duke.edu

Health Affairs (Project Hope)
|March 9, 2006
PubMed
Summary

Drug manufacturers spent an estimated $800 million on post-approval safety in 2003. This study provides crucial data on pharmaceutical safety surveillance spending and its relation to adverse event reporting.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Pharmaceutical Economics
  • Regulatory Science

Background:

  • High-profile pharmaceutical withdrawals highlight the need for robust post-approval safety surveillance.
  • Previous assessments of post-approval safety spending lack systematic data.
  • Understanding industry investment in safety is critical for regulatory and policy discussions.

Purpose of the Study:

  • To systematically assess spending on post-approval drug safety by pharmaceutical manufacturers.
  • To investigate the relationship between safety personnel and adverse event reporting.
  • To inform ongoing debates regarding proposed changes to drug safety surveillance systems.

Main Methods:

  • A survey of drug manufacturers was conducted to gather data on safety expenditures.

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  • Mean spending on post-approval safety per company was calculated for 2003.
  • Regression analysis was used to examine the correlation between safety personnel and initial adverse event reports.

    • Main Results:

    • In 2003, average spending on post-approval safety was $56 million per company, representing 0.3% of sales.
    • Estimated total post-approval safety spending by the top twenty drug manufacturers reached $800 million in 2003.
    • A positive relationship was observed between the number of safety personnel and initial adverse event reports.

    Conclusions:

    • Pharmaceutical companies invest significantly in post-approval safety surveillance, with substantial financial resources allocated.
    • The findings provide empirical data to support discussions on optimizing drug safety monitoring and resource allocation.
    • This research contributes valuable insights into the economic aspects of pharmacovigilance and its impact on public health protection.