Food and Drug Administration Oversight: Origins and Contribution to the National Covid Response
Running Title: FDA Oversight: Origins and Contributions to the Covid Response
DOI:
https://doi.org/10.21423/JRS.REGSCI.121274Keywords:
Emergency Use Authorizations (EUAs), Administrative Law, Covid-19Abstract
The Food and Drug Administration (FDA) has been a key actor in the USA’s response to the Covid-19 pandemic. The extensive use of Emergency Use Authorizations (EUAs) during the pandemic as part of its broader strategy to protect the health of the country has raised this federal agency to the public psyche. The FDA’s response has been guided by its position within the national governing framework as well as its own unique history. A review of this framework and the FDA’s history can be illuminating in understanding this agency’s response during a national crisis.
References
, from https://www.usa.gov/federal-agencies
Authorization for medical products for use in emergencies, (2017).
Byard, R. W. (2013). Diphtheria-’The strangling angel’ of children. In Journal of Forensic and Legal Medicine (Vol. 20, Issue 2, pp. 65–68). https://doi.org/10.1016/j.jflm.2012.04.006
Dearborn, J. A. (2019). The Proper Organs for Presidential Representation: A Fresh Look at the Budget and Accounting Act of 1921. Journal of Policy History, 31(1), 1–41. https://doi.org/10.1017/S0898030618000325
DeHovitz, R. E. (2014). The 1901 St Louis incident: The first modern medical disaster. In Pediatrics (Vol. 133, Issue 6, pp. 964–965). American Academy of Pediatrics. https://doi.org/10.1542/peds.2013-2817
Douglas Crimp. (2011, December 6). Before Occupy: How AIDS Activists Seized Control of the FDA in 1988. The Atlantic. https://www.theatlantic.com/health/archive/2011/12/before-occupy-how-aids-activists-seized-control-of-the-fda-in-1988/249302/
Drug Amendments of 1962, Pub. L. No. 76 Stat. 780 (1962).
Emergency Use Authorization. (2023, May 2). US Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Expanded Access. (2022, December 21). US Food and Drug Administration Website. https://www.fda.gov/news-events/public-health-focus/expanded-access
Fact Sheet: FDA at a Glance. (n.d.). Retrieved December 7, 2022, from https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. (2018, February 23). US Food and Drug Administration Website. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
Federal, Food, Drug, and Cosmetic Act, Pub. L. No. 52 Stat. 1040, 1938.
Garvey, T. (2017). A Brief Overview of Rulemaking and Judicial Review. www.crs.gov
Kavanaugh And The “Chevron Doctrine” _ Hoover Institution Kavanaugh And The “Chevron Doctrine.” (n.d.).
Kennedy, D. (2006). FDA centennial. In Science (Vol. 312, Issue 5770, p. 19). https://doi.org/10.1126/science.1127486
Meredith Francis. (n.d.). How Upton Sinclair’s “The Jungle” Unintentionally Spurred Food Safety Laws. Retrieved December 7, 2022, from https://interactive.wttw.com/playlist/2020/01/23/the-jungle-food-safety
National Primary Drinking Water Regulations. (n.d.). Retrieved December 7, 2022, from https://www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations
Strauss, P. L. (1984). Scholarship Archive Scholarship Archive The Place of Agencies in Government: Separation of Powers and The Place of Agencies in Government: Separation of Powers and the Fourth Branch the Fourth Branch THE PLACE OF AGENCIES IN GOVERNMENT: SEPARATION OF POWERS AND THE FOURTH BRANCH. In COLUMBIA LAW REVIEW (Vol. 84, Issue 3). https://scholarship.law.columbia.edu/faculty_scholarshiphttps://scholarship.law.columbia.edu/faculty_scholarship/208
Summary of the Clean Water Act. (n.d.). Retrieved December 7, 2022, from https://www.epa.gov/laws-regulations/summary-clean-water-act#:~:text=(1972),quality%20standards%20for%20surface%20waters.
Texas Medical Board. (n.d.). Retrieved December 7, 2022, from https://www.tmb.state.tx.us/page/licensing
Downloads
Published
Versions
- 2024-02-28 (2)
- 2024-02-05 (1)
Issue
Section
License
Copyright (c) 2024 Bradley Grant, Michael Laposata, Christopher Zahner
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
By submitting content to the Journal of Regulatory Science (JRS), authors agree to the following terms:
- Authors retain copyright and grant the JRS the right of first publication. Authors retain patent, trademark, and other intellectual property rights (including research data) and grant third parties the right to use, reproduce, and share the article according to the Creative Commons — Attribution-NonCommercial 4.0 International — CC BY-NC 4.0 license agreement. The JRS is an open access journal and, as a result, articles are free to use with proper acknowledgment of the work's authorship and initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process.
- If excerpts from other copyrighted works are included, the author(s) must obtain written permission from the copyright owners and credit the source(s) in the article.
- The publication of the submission has been approved by all co-authors and responsible authorities at the institute or organization where the work has been carried out.
- Copyright has not been breached in seeking publication of the submission.
