A Measure of Value: FDA in the Age of COVID
An Agency in the Right Place at the Right Time
DOI:
https://doi.org/10.21423/JRS-V10I1BENINGERKeywords:
hierarchical layers and components of the regulatory system, approaches to understanding value, COVID-19 as an overarching case study with representative scenariosAbstract
The US Food and Drug Administration (FDA) is the institutional regulatory gateway through which healthcare business sectors gain access to commercial markets in pharmaceuticals, biologicals, vaccines, medical devices, diagnostic test kits and persona protective equipment. The unfolding of events for the COVID-19 pandemic serve as a case study for understanding, in real time, how FDA has contributed value to the healthcare sector.
Federal regulatory agencies, such as FDA, require strong processes to provide fair and consistent outcomes to retain the trust of the stakeholder community. These processes include statutes and regulations, internal manual of standard operating procedures and policies, guidance documents, external advisory committees and the Office of Inspector General. These processes cover the following activities: product development conditions, regulatory pathways, types of approvals, manufacturing quality, and post marketing safety. Together, the institutional experiences that led to and shaped these processes prepared FDA for the challenges associated with COVID-19.
The sum of twelve decades of experience comes down to the following goals that provide value to the degree with which each is successful: 1) The manufacturing process must meet standards of quality and be secured. 2) Medical products must be shown, through scientific evidence and based on evidentiary standards, to be safe and effective for human use. 3) Identified risks must be mitigated, by labeling at a minimum, with additional strategies as necessary. 4) Provisions must exist for extraordinary circumstances of limited unmet medical needs and of threats to public health and national security.
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