Robertson Andrew S
Ph.D., JD, Global Regulatory Policy Director, Merck & Co.
Am J Law Med. 2016 May;42(2-3):524-542. doi: 10.1177/0098858816658278.
In December 2014, the United States government expanded the Priority Review Voucher ("PRV" or "voucher") program to include Ebola and other related Filoviruses. By doing so, lawmakers provided a potentially powerful incentive for drug companies to invest time and money in the development of novel medicines for terrifying diseases. This expansion is one of several additions made to the PRV programs since 2012. Many companies rely on voucher resale to recoup research and development ("R&D") costs; however, it is unclear whether the PRV program could be overextended, thereby diluting the value of the incentives. In this paper, I use historical approval data from the Food and Drug Administration ("FDA") and United States drug revenue data to better understand the secondary market value of a PRV. The data suggests that that purchase prices of a PRV could continue to climb; despite this, the market size for these vouchers is limited. The implications of these findings are discussed further.
2014年12月，美国政府扩大了优先审评券（“PRV”或“审评券”）计划，将埃博拉病毒及其他相关丝状病毒纳入其中。通过此举，立法者为制药公司投入时间和资金研发针对可怕疾病的新型药物提供了一项潜在的有力激励措施。此次扩张是自2012年以来对PRV计划所做的多项补充之一。许多公司依靠审评券转售来收回研发成本；然而，尚不清楚PRV计划是否可能过度扩张，从而削弱激励措施的价值。在本文中，我利用美国食品药品监督管理局（“FDA”）的历史批准数据和美国药品收入数据，以便更好地了解PRV的二级市场价值。数据表明，PRV的购买价格可能会继续攀升；尽管如此，这些审评券的市场规模有限。这些研究结果的影响将进一步讨论。
