In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD)
in history. At the onset of the outbreak—as now—there were no therapies approved by
the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis
against, or treatment of EVD. As a result, the outbreak spurred interest in developing
novel treatments, sparked calls to use experimental interventions in the field, and
highlighted challenges to the standard approach to FDA approval of new drugs. Although
the outbreak was geographically centered in West Africa, it showcased FDA's global
role in drug development, approval, and access. FDA's response to EVD highlights the
panoply of agency powers and demonstrates the flexibility of FDA's regulatory framework.
This paper evaluates the strengths and weaknesses of FDA's response and makes policy
recommendations regarding how FDA should respond to new and re-emerging public health
threats. In particular, it argues that greater emphasis should be placed on drug development
in interoutbreak periods and on assuring access to approved products. The current
pandemic of Zika virus infection is but one example of an emerging health threat that
will require FDA involvement in order to achieve a successful response.