Preparing for Disease X:
History, Legislative Innovation, and Future
Daniel A. Kracov
Given the uncertain attributes of future pathogens, the next pandemic (or bioterror) threat may place an even greater premium on the availability of effective diagnostics, prophylactics, and treatments — at large scale— at the earliest stage of a pandemic, before hundreds of thousands have died and our economy is devastated. This Article traces the mixed history of our efforts to support and incentivize the development of public health countermeasures, from the failure of the first such legislation—the 1813 Vaccine Act—to the later development of the Public Health Service Act; Federal Food, Drug, and Cosmetic Act; and various statutes and amendments providing important incentive and other mechanisms focused on the development of public health countermeasures. While such legislative innovations have spurred decades of massive investments in research and development, saving millions of lives and creating the environment for the remarkably rapid development of COVID-19 vaccines and other countermeasures, the pandemic has revealed that even these measures may be inadequate to meet the public health demands of our age. Specifically, the problems emerging in the COVID-19 pandemic suggest that we need even more powerful and customized incentives if we are to limit the impact of future “Disease X” threats via stockpiled, broad spectrum, and immediately deployable prophylactic, therapeutic, and diagnostic technologies necessary to address the next pandemic. To address this gap, this paper proposes a statutory framework that would offer bespoke “Incentive Models” tailored to clearly identified, highest value public health countermeasure development and stockpiling goals and incorporate strong push and pull incentives. Such Incentive Models could be based on an analysis of the relevant market, as well as scientific, infrastructure, and other impediments to achieving a specific critical countermeasure goal. Further, to the extent possible, such Incentive Models and associated activities should be ring-fenced from undue political interference, “pay as you go” appropriations requirements, and the threat of arbitrary diversion of funding.
Food and Drug Law Journal
Volume 76, Number 2