Priorities for the Priority Review Voucher
Open accessAbstract
The U.S. Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. Under the voucher program, the developer of a drug for a neglected or rare pediatric disease that is approved by the U.S. Food and Drug Administration receives a bonus priority review voucher for another drug. As of 2016, four vouchers have sold for an average price of $200 million. Recent experience with the voucher program indicates strengths and weaknesses of the program, as well as a need for legislative changes.
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Neglected and tropical diseases such as tuberculosis and malaria have very large datasets (>300,000 compounds) from high-throughput screening which can be utilized for machine learning.
“these diseases are in the enviable position of having very large datasets (>300,000 compounds) from high-throughput screening which can be utilized for machine learning53.”
From Exploiting machine learning for end-to-end drug discovery and development (2019) · cites this paper as [53]
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Cites
Estimating The Cost Of New Drug Development: Is It Really $802 Million?
Adams, C., & Brantner, V. V. (2006) · Health Affairs · doi:10.1377/hlthaff.25.2.420 · Cited by 917 · see citing works
Developing Drugs For Developing Countries
Ridley, D. B., Grabowski, H. G., & Moe, J. L. (2006) · Health Affairs · doi:10.1377/hlthaff.25.2.313 · Cited by 198 · see citing works
Self-citationBerndt, E. R., Glennerster, R., Kremer, M. R., Lee, J., Levine, R., Weizsäcker, G., & Williams, H. (2006) · Health Economics · doi:10.1002/hec.1176 · Cited by 120 · see citing works
The Commercial Market For Priority Review Vouchers
Ridley, D. B., & Régnier, S. A. (2016) · Health Affairs · doi:10.1377/hlthaff.2015.1314 · Cited by 38 · see citing works
Self-citationExperience With the Priority Review Voucher Program for Drug Development
Kesselheim, A. S., Maggs, L. R., & Sarpatwari, A. (2015) · JAMA · doi:10.1001/jama.2015.11845 · Cited by 36 · see citing works
The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products
Berman, J. D., & Radhakrishna, T. (2016) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.16-0099 · Cited by 17 · see citing works
Kesselheim, A. S. (2009) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2009.50 · Cited by 9 · see citing works
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Exploiting machine learning for end-to-end drug discovery and development
Ekins, S., Puhl, A. C., Zorn, K. M., Lane, T. R., Russo, D. P., Klein, J. J., Hickey, A. J., & Clark, A. M. (2019) · Nature Materials · doi:10.1038/s41563-019-0338-z · Cited by 578 · see citing works
- Authors
- Ridley, D. B.
- Affiliations
- Duke University (US)
- Corresponding author
- Ridley, David B.
- ORCID
- Ridley, David B.
- Venue
- The American Society of Tropical Medicine and Hygiene
- Published
- 2017-01-11
- Volume
- 96
- Issue
- 1
- Pages
- 14-15
- ISSN
- 0002-9637 (ISSN-L)
- 1476-1645
- PMC
- PMC5239680
- OpenAlex
- W2511706873
- Cited by
- 15
- References
- 7
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 2 · 2021: 1 · 2020: 2 · 2019: 3 · 2018: 4 · 2017: 1
- FWCI
- 5.18
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- American Journal of Tropical Medicine and Hygiene (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DukeSpace (Duke University) (submittedVersion, cc-by-nc-nd)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- priority review voucher, neglected diseases, pediatric rare diseases, drug development incentives, legal reform, drug pricing, FDA drug approval
- MeSH terms
- Anti-Infective Agents, Pharmaceutical Preparations, Humans, Orphan Drug Production, Tropical Medicine, United States, United States Food and Drug Administration, Drug Approval, Drug Discovery, Neglected Diseases
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