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. 2017 Jul 25;318(4):388-389.
doi: 10.1001/jama.2017.7467.

Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development

Nina Jain  1 , Thomas Hwang  1 , Jessica M Franklin  1 , Aaron S Kesselheim  1
Affiliations

Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development

Nina Jain et al. JAMA. .

Abstract

This study uses commercial pharmaceutical database data to evaluate the number of new drugs and vaccines for neglected tropical diseases entering phase 1 clinical trials before and after introduction in 2007 of a priority review voucher program to incentivize development.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Franklin reports receiving funding from the Patient-Centered Outcomes Research Institute and Merck and consulting for Aetion, a software company. Mr Hwang reports being previously employed by Blackstone and Bain Capital, which has invested in health care companies. Dr Jain reports receiving an award from Merck. No other disclosures were reported.

Figures

Figure.
Figure.. Neglected Tropical Disease Phase 1 Trial Initiation, 2000-2014
Congress created the priority review voucher in 2007 to incentivize the development of treatments for neglected tropical diseases. The number of voucher-eligible pharmaceutical products entering phase 1 trials was identified for each year from 2000-2014. The Figure shows trend lines fit to the data separately for the years 2000-2007 and 2008-2014. For 2000-2007, the mean No. of voucher-eligible pharmaceutical products entering phase 1 trials per year was 4 (median, 4.5 [range, 1 to 6]). For 2008-2014, the mean No. of voucher-eligible pharmaceutical products entering phase 1 trials per year was 4.9 (median, 5 [range, 2 to 7]). The percentage of new neglected tropical disease drugs is the proportion of all phase 1 trials for drugs with a neglected tropical disease indication. This proportion decreased by 1.74% per year before 2007 (95% CI, −13.68% to 12.87%) and decreased by 1.73% after 2007 (95% CI, −12.75% to 10.27%).
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References

    1. US Food and Drug Administration Tropical disease priority review vouchers: guidance for industry. https://www.fda.gov/downloads/Drugs/.../Guidances/UCM080599.pdf. Accessed December 21, 2016.
    1. Kesselheim AS, Maggs LR, Sarpatwari A. Experience with the priority review voucher program for drug development. JAMA. 2015;314(16):1687-1688. - PubMed
    1. US Food and Drug Administration FDA approves vaccine to prevent cholera for travelers. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm506305.htm. Accessed May 10, 2017.
    1. Pharma Intelligence Pharmaprojects. https://pharmaintelligence.informa.com/products-and-services/data-and-an.... Accessed June 30, 2016.
    1. Ridley DB, Régnier SA. The commercial market for priority review vouchers. Health Aff (Millwood). 2016;35(5):776-783. - PubMed

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