Public Sector Capacity: Keeping Pace with Genome Altering Technology at the FDA

• In Event: Politics of Science and Technology Here and Elsewhere

Abstract

Abstract: This study examines the regulatory processes surrounding approval for human clinical trials of therapies using genomic modification (e.g. CRISPR) and finds that regulators do not lag their private sector counterparts when it comes to the science required to test the safety and effectiveness of such therapies.These findings, drawn from original data collected during qualitative, in-depth interviews with scientists working on medical therapies using genomic modification and with current and former FDA staff, challenge the common assumption about information asymmetries between regulators and the regulated and contribute to a growing literature on public sector capacity. Whereas theories of public choice and reputation have been cast as opposing frameworks for understanding agency outcomes, this analysis brings the two together, arguing that actors pushing innovative and potentially high-risk technologies fear public backlash if innovative technologies are not carefully managed and see expert regulators as a check on risky innovation.

Authors

• Ann C. Keller, University of California-Berkeley

• Konrad Posch, University of California, Berkeley

• Margaret Taylor, Lawrence Berkeley National Laboratory

• Brian Scholl, IZA-Bonn

• Alexa K Tisopulos, University of California, Berkeley