The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

Abstract

Purpose Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how? Methods Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines) and innovation (corresponding FDA-registrations) from 1976–2020 are used to determine interdependence, a concept relying on strong correlation and reciprocal causality (estimated via variable lag transfer entropy and wavelet coherence). Results Based on the observed interdependence, a mapping of regulation onto innovation is conducted and finds that regulation seems to accelerate then supports innovation until on or around 2015; at which time, an inverted U-curve emerged. Conclusions If empirically evidentiary, an important innovation-regulation nexus in the US has been reached; and, as such, stakeholders should (re)consider the complexity of the regulatory landscape to enhance US medical product innovation. Study limitations, extensions, and further thoughts complete this investigation. Graphical abstract Supplementary Information The online version contains supplementary material available at 10.1007/s11095-023-03512-1.