Stepping Up or Stepping Back: FDA Roles in Producing and Shaping Knowledge of Pediatric Covid-19 Vaccines.

Abstract

We agree with Svirsky, Howard, and Berman (2022) that the US Food and Drug Administration (FDA) plays various roles, only one of which is the technical review and evaluation of product safety and efficacy. The authors suggest that in addition to this role as knowledge purveyor, the FDA ought to be sensitive to its roles as knowledge producer (creating new knowledge through its review process), advisor (communicating knowledge that it creates or assesses), and market agent (“shaping the market conditions in which people make health related choices”) when issuing decisions. We agree that each are roles the FDA may play implicitly, if not explicitly. But we question whether each role is appropriate to the agency in all cases, especially when other agencies may have more relevant expertise or authority to fulfill certain roles. We show that comparing the FDA’s roles in ecigarette regulation to the FDA’s roles in pediatric Covid-19 vaccine authorization adds nuance to the authors’ conclusions, suggesting important differences in the FDA’s role(s) depending on the type of product it is reviewing and the availability and appropriateness of other agencies, such as the Centers for Disease Control and Prevention (CDC), to fulfill certain of these roles. Specifically, the example of pediatric Covid-19 vaccine FDA review suggests that the FDA’s ancillary roles may have overshadowed its core evaluation functions. KNOWLEDGE PURVEYOR