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​US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access.

David B Ridley1, Pranav Ganapathy2, Hannah E Kettler3

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Summary
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The Tropical Disease Priority Review Voucher program incentivizes infectious disease drug development. Case studies show it impacts product innovation and access, warranting its protection and complementary policies.

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Area of Science:

  • Public Health
  • Infectious Diseases
  • Health Policy

Background:

  • The COVID-19 pandemic highlighted the need for infectious disease prevention and treatment investments.
  • The US government previously offered the Tropical Disease Priority Review Voucher program as a major incentive for developing drugs and vaccines for tropical infectious diseases.
  • This voucher allows expedited review of one new drug by the Food and Drug Administration.

Purpose of the Study:

  • To evaluate the impact of the Tropical Disease Priority Review Voucher program on pharmaceutical innovation and drug accessibility.
  • To provide case studies of voucher recipients between 2007 and 2018.
  • To inform policy recommendations for the future of the voucher program.

Main Methods:

  • Analysis of case studies from 2007 to 2018 focusing on Tropical Disease Priority Review Voucher recipients.
  • Examination of the effects of the voucher program on the development and availability of new drugs and vaccines.
  • Assessment of the program's influence on product innovation and market access.

Main Results:

  • The Tropical Disease Priority Review Voucher program has influenced the development of new treatments for tropical infectious diseases.
  • The program's effects on product innovation and patient access require careful consideration.
  • Specific case studies illustrate the program's successes and limitations.

Conclusions:

  • The Tropical Disease Priority Review Voucher program has been a significant, albeit imperfect, incentive for tropical disease drug development.
  • Policy makers should safeguard the existing voucher program.
  • Complementary incentives should be developed to further enhance infectious disease research and development.