Description: A US scheme where companies who create drugs for neglected diseases are given a voucher for use on another drug which will expedite the FDA review process.
Start date: Proposed in 2006, launched in 2007.
Status: Operational.
In 2007, PRVs were included as the Elimination of Neglected Diseases Amendment in the Food and Drug Administration (FDA) Amendments Act.1 This created a scheme whereby if a company created a drug for a neglected disease, they could apply to be rewarded with a PRV. This could then be used to expedite the review process on another drug. PRVs can also be sold to other drugs companies.
PRVs were initially proposed in a paper by Ridley, Grabowski, and Moe in 2006.2 The original proposal included compulsory non-patenting of the neglected drug, but the final act did not.3
In 2012, the PRV scheme was extended to rare paediatric diseases.4
The estimated value of a voucher is \$100-300 million.5
Scope: PRVs in the US apply to neglected diseases and rare paediatric diseases. They relate to final products.
Access: There is no impact on the price of drugs. PRVs do not incentivise distribution.
Innovation: Incentives are not linked to health impact. The reward of PRVs is such that it is unlikely to incentivise full-blown neglected disease research. It is more likely that they speed up ND research that would have happened anyway.6
Efficiency: The PRV system is very cheap to administer (though not actually costless).7 The system is not market-based.
Governability: The PRV system uses existing FDA administration, so is relatively light of governance. It requires specification of which drugs count as neglected, but from that point on is relatively straightforward to administer. The PRV process if fairly technical, and there do not seem to have been claims that the system has been influenced politically.
Political Feasibility: PRVs are patent compatible, and have been successfully implemented.
A PRV is a kind of Transferable Fast Track (TFT).
Transferable Intellectual Property Rights (TIPR) are similar, but instead of granting expedited review in exchange for the development of a neglected drug, companies are granted market exclusivity. An examples of a TIPR style proposal is the US paediatric initiative.8
Ridley and Sanchez also proposed an EU PRV system in 2010.9 In addition to accelerating market authorisation like the US scheme, the EU scheme would also accelerate pricing and reimbursement decisions, as the European Medicine Agency unlike the FDA has considerable control over this. Under the US scheme PRVs can only be sold once, but Ridley and Sanchez proposed for the EU scheme that PRVs be transferable multiple times.
Targeted at:
Drugs companies
The FDA
The US government
Stakeholders on board:
FDA
Ridley, Grabowski, and Moe
The original proposal: Ridley, David B., Henry G. Grabowski, and Jeffrey L. Moe. “Developing Drugs for Developing Countries.” Health Affairs The actual legislation: “Full Text of FDAAA Law.” WebContent. Accessed June 26, 2017. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/FullTextofFDAAALaw/default.htm.
Regulatory information page: Commissioner, Office of the. “Food and Drug Administration Amendments Act (FDAAA) of 2007.” WebContent. Accessed June 26, 2017. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm.
Reviews:
A brief article claiming that PRVs are inefficient: Kesselheim, Aaron S. “Drug Development for Neglected Diseases — The Trouble with FDA Review Vouchers.” New England Journal of Medicine 359, no. 19 (November 6, 2008): 1981–83. doi:10.1056/NEJMp0806684.
A critical review of the first 6 PRVs awarded: Kesselheim, Aaron S., Lara R. Maggs, and Ameet Sarpatwari. “Experience With the Priority Review Voucher Program for Drug Development.” JAMA 314, no. 16 (October 27, 2015): 1687–88. doi:10.1001/jama.2015.11845.
The view from a Product Development Partnership (PDP), also providing basic summary of the mechanism: “Priority Review Vouchers: A Closer Look | Sabin.” Accessed June 26, 2017. http://www.sabin.org/updates/blog/priority-review-vouchers-clo er-look.
The view from big pharma, including criticisms of the risk of investment: Berman, Jonathan, and Tanya Radhakrishna. “The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products.” The American Journal of Tropical Medicine and Hygiene 96, no. 1 (January 11, 2017): 11–13. doi:10.4269/ajtmh.16-0099.
A response to Berman and Radhakrishna: Ridley, David B. “Priorities for the Priority Review Voucher.” The American Journal of Tropical Medicine and Hygiene 96, no. 1 (January 11, 2017): 14–15. doi:10.4269/ajtmh.16-0600.
General information on TFTs:
Gans, Joshua S., and David B. Ridley. “Innovation Incentives under Transferable Fast-Track Regulatory Review.” The Journal of Industrial Economics 61, no. 3 (September 1, 2013): 789–816. doi:10.1111/joie.12026.
General information on PRVs:
“Food and Drug Administration Amendments Act of 2007.” Wikipedia, March 22, 2017. https://en.wikipedia.org/w/index.php?title=Food_and_Drug_Administration_Amendments_Act_of_2007&oldid=771604264.
“Priority Review (FDA).” Wikipedia, June 23, 2017. https://en.wikipedia.org/w/index.php?title=Priority_review_(FDA)&oldid=787105010.
“[Priorityreviewvoucher.org]{.underline}.” Accessed June 26, 2017. http://priorityreviewvoucher.org/.
News:
“Priority Review Voucher Fees to Decline in FY 2017 | RAPS.” Accessed June 26, 2017. http://www.raps.org/Regulatory-Focus/News/2016/09/29/25926/Priority-Review-Voucher-Fees-to-Decline-in-FY-2017/.
“What Happened to the Value of Priority Review Vouchers (PRV)?” Locust Walk, March 2, 2017. http://www.locustwalk.com/what-happened-to-the-value-of-priority-review-vouchers-prv/.
Extension to paediatric diseases: Commissioner, Office of the. “Rare Pediatric Disease Priority Review Voucher Program.” WebContent. Accessed July 6, 2017. https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/rarepediatricdiseasepriorityvoucherprogram/default.htm.
A European proposal: Ridley, David B, and Alfonso Calles Sánchez. “Introduction of European Priority Review Vouchers to Encourage Development of New Medicines for Neglected Diseases.” The Lancet 376, no. 9744 (September 11, 2010): 922–27. doi:10.1016/S0140-6736(10)60669-1.
