Over the last several years, scholars studying health innovation policy have carefully considered the ways in which policymakers regulate different types of technologies to encourage their development and dissemination. Scholars have examined a range of legal incentives, including patents, Food and Drug Administration (FDA) exclusivity periods, taxes, grants, insurance reimbursement, and other tools to promote socially valuable innovations that our current system has structurally disfavored.
However, this research has neglected the temporal dimension of the issue. Specifically, a large set of innovations in the life sciences may be considered to be intermediate innovations. Scientists continue to improve these technologies over time, even as the initial products are made available to patients. Yet the relevant innovation policy levers do not consider whether intermediate technologies ought to be regulated differently from technologies which are further along in the development process.
Whether our existing regulatory frameworks are cognizant of
an innovation’s stage of development matters. If the regulatory structure
around the intermediate technology is not appropriately calibrated, the
technology could be frozen in time such that future development does not occur.
This failure would be harmful both for public health and for societal welfare.
Policy levers that appear targeted at early-stage technologies in fact lack a
fit with these considerations.
This Article articulates the problem of
regulating intermediate technologies in the life sciences and considers how
existing laws and regulations might be altered to accommodate the situation. It
argues that some of the FDA’s existing regulatory approaches are capable of
addressing the problem, and others can be altered to do so. Other solutions may
lie in the realm of reimbursement, where the stage of a technology could play
into the payments made by insurers for that technology.