Putting a Pricetag on Life: The Value of Life and the FDA

Abstract

Regulatory agencies like the Food and Drug Administration are in the business of protecting American lives. These agencies are constantly making judgment calls as to whether prospective products are sufficiently safe, whether proposed regulations will do more harm than good, and whether costs of compliance will justify the benefits. And yet, what cost is too high to save a human life? Although we would like to live in a world that needed not spare any expense to save a life, we know that ours is a world of scarcity. This fact requires that we, as a society, make difficult decisions about how much to spend to save lives – in other words, how to value human life. This paper first looks at different theoretical approaches for deriving a value of life, and asks which is the most appropriate for use in the regulatory context. The paper next considers the legal framework that plays a role in guiding agencies in the use of value of life figures. Finally, the paper examines the practices of regulatory agencies, the FDA in particular, regarding setting a value of life, and applying it in their decision-making. A web of legal authority, political pressures, and shear administrative difficulties come into play. Together, these competing influences create significant challenges to the usefulness of value of life analysis.