Effects of National Emergency on Federal Agency Approval Processes of Newly Introduced Vaccines

Authors

Jeannette Krystle Colwell, Florida International UniversityFollow

Document Type

Dissertation

Degree

Doctor of Philosophy (PhD)

Major/Program

Public Affairs

First Advisor's Name

Meredith Newman

First Advisor's Committee Title

Committee Chair

Second Advisor's Name

Sukumar Ganapati

Second Advisor's Committee Title

Committee Member

Third Advisor's Name

Keith Revell

Third Advisor's Committee Title

Committee Member

Fourth Advisor's Name

Alejandro Arrieta

Fourth Advisor's Committee Title

Committe Member

Keywords

Federal, Agency, Decision-making, FDA, Policy, Lobbying, Interest, President, National Emergency

Date of Defense

6-28-2024

Abstract

This research is an exploration of how federal agencies approve vaccines during emergency vis-à-vis non-emergency conditions. The Food and Drug Administration (FDA) is responsible for approving vaccines based on scientific data and expertise. Vaccines undergo a stringent process of testing before final approval. When there is a national emergency, the FDA can declare an Emergency Use Authorization, whereby the agency allows unapproved medical products to diagnose, treat, or prevent diseases. It is in this context that this dissertation explores the roles of the president and the public in EUA declarations with respect to vaccines. This dissertation analyses two propositions. Proposition 1: During a national emergency, the President can influence the FDA’s legal duty to make science-based decisions. Proposition 2: The FDA’s EUA declaration is not just a bureaucratic or scientific function. Rather, the FDA must be responsive to political and public sensibilities when formulating an EUA approval. The FDA’s role is not merely of legal compliance, but to be responsive to interactions with larger forces. These propositions are viewed through a comparative analysis of four vaccine approval cases during a time of national emergency or non-emergency. This qualitative research conducts an interpretive analysis of congressional documents and is supplemented by coverage of major newspapers and semi-structured interviews with experts involved in the approval process. Presidential input over federal agency decisions are historically limited to funding or statements of support. However, the findings for proposition 1 show that during a national emergency, there is a shift in presidential pressure over agency decisions. Agency actions that are normally determined from bureaucratic expertise are weakened due to presidential pressure. With respect to proposition 2, a declaration of national emergency opens what Kingdon (2011) labels as a “window,” or opportunity to push policy approvals. National emergencies alter the level of engagement from the public and stakeholders. Agencies must maintain high levels of communication with the public, without negatively impacting their work and reputation. Overall, this dissertation highlights the need for policies that protect agency decisions from insurmountable pressures from the Office of The President and the public during a time of national emergency.

Identifier

FIDC011226

Recommended Citation

Colwell, Jeannette Krystle, "Effects of National Emergency on Federal Agency Approval Processes of Newly Introduced Vaccines" (2024). FIU Electronic Theses and Dissertations. 5392.
https://digitalcommons.fiu.edu/etd/5392