¶ Food and Drug Administration
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The United States Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services (HHS) responsible for regulation of a wide range of food and medical products. It is responsible for regulating the “safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices” and “ensuring the safety of [the United States’] food supply, cosmetics, and products that emit radiation.”[1][2]
The current Commissioner of the FDA is Dr. Robert M. Califf.[3]
¶ History
The FDA was officially founded in 1906 when U.S. President Theodore Roosevelt signed the Pure Food and Drugs Act into law. The bill is described as the “culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace.”[4] A primary motivation behind the creation of the FDA was to “prohibit the adulteration and misbranding of food and drugs.”[5]
¶ Prescription Drug User Fee Act
In 1992, the United States Congress enacted the Prescription Drug User Fee Act (PDUFA) which made it legal for the FDA to receive “user fees” from pharmaceutical companies for each new drug submitted for review.[6] This allowed the agency to dramatically increase the rate at which new drugs were approved by expanding its staff, leading to record-breaking numbers of new drug approvals by 1996. To expedite the process still further, the FDA introduced a new “priority application” service that allowed drugs to be approved in half the time that “standard applications” previously required.[7] In 1993, 27% of the portion of the FDA’s budget specifically earmarked for reviewing new drugs was paid for by the pharmaceutical industry. This figure increased to over 50% by 2006,[8] and 75% by 2017.[9]
In 2007, the U.S. Congress established the Reagan-Udall Foundation for the Food and Drug Administration, otherwise known as the FDA Foundation, through the Food and Drug Administration Amendments Act of 2007.[10]
On June 27, 2017, the FDA signed a memorandum of understanding (MOU) with the Bill & Melinda Gates Foundation "to facilitate existing and new mutually agreed upon programs and activities and to carry out their common goal to improve public health by stimulating and fostering medical product innovation and enabling medical product development."[11][12]
From 2019-2021, the FDA’s overall budget increased from $5.7 billion to $6.1 billion, of which 45-46% came from the pharmaceutical industry through the above-described “user fees.”[13][14][15]
¶ COVID-19
On May 1, 2020, FDA chief scientist Denise Hinton issued a letter to Gilead Sciences granting an Emergency Use Authorization for its experimental RNA inhibiting drug, remdesivir, for use in COVID-19 patients.[16]
In the fall of 2020, the FDA recruited the Reagan-Udall Foundation to run a $209,094 “COVID-19 vaccine confidence project” following the recommendations of the Johns Hopkins Center for Health Security (JHCFS) Working Group on Readying Populations for COVID-19 Vaccine.[17][18] Specifically, the project involved identifying causes of so-called “vaccine hesitancy” in various target populations and developing “a set of messages that responded to their concerns.” These messages were then “delivered to FDA for use in their messaging.”
In May 2021, Pfizer paid the FDA a $2.8 million application fee for Emergency Use Authorization of its COVID-19 mRNA-based vaccine product, BNT162b2, developed by BioNTech.[19] Less than two months of safety data was available for BNT162b2 at the time of its authorization.[20]
Robert Califf was promoted to FDA director on February 17, 2022.[3:1]
On July 13, 2022, the FDA granted an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine.[21]
¶ Organization
The FDA is a research partner of the National COVID Cohort Collaborative.[22]
¶ Collaborators
The FDA has signed memoranda of understanding with:[11:1]
- Academy of Nutrition and Dietetics
- Alliance of Multicultural Physicians
- American Association for Cancer Research
- American Association of Veterinary State Boards
- American Chemical Society
- American College of Toxicity (ACT)
- American Institute for Medical and Biological Engineering (AIMBE)
- American Medical Association (AMA)
- American Nurses Association
- American Pharmacists Association (APhA)
- American Society of Health-System Pharmacists
- American Society of Nephrology
- AOAC
- Association of Healthcare Resource and Materials Management
- Avicenna Alliance
- Banfield Pet Hospital
- Bill & Melinda Gates Foundation
- Blacks in Government (BIG)
- CloudWave
- Conference for Food Protection (CFP)
- Critical Path Institute
- Food and Drug Administration Alumni Association (FDAAA)
- Heads of the European Radiological protection Competent Authorities (HERCA)
- Healheo360
- Health and Environmental Sciences Institute
- Health Information Sharing and Analysis Center
- Hematology/Oncology Pharmacy Association (HOPA)
- Independent Laboratories Institute
- Inova Heart and Vascular Institute
- Institute for Safe Medication Practices
- Institute of Quantitative Systems Pharmacology
- Interstate Shellfish Sanitation Conference
- Karolinska Institute
- MedISAO
- Medscape
- National Association of Attorneys General
- National Conference on Interstate Milk Shipments
- National Council for Prescription Drug Programs
- National Forum for Heart Disease & Stroke Prevention
- National Organization for Rare Disorders (NORD)
- National Treasury Employees Union (NTEU)
- Oncology Nursing Society
- Reagan-Udall Foundation for the Food and Drug Administration
- Society for Clinical Research Sites
- Society of Toxicology
- St. Jude Children’s Research Hospital
- Stockholm County Healthcare Services
- Truth Initiative
- United States Pharmacopeia (USP)
- Uppsala Monitoring Centre
- Washington Adventist Hospital
- WebMD
An industry association called the Alliance for a Stronger FDA lobbies the United States Congress for increased annual funding allocations to the FDA. Between 2019-2021, the Alliance spent some $855,000 on its lobbying activities.[23]
¶ Reagan-Udall Foundation
The Reagan-Udall Foundation for the Food and Drug Administration, also known as the FDA Foundation, is a Congressionally-created non-profit organization that works in partnership with the FDA. Officially, this foundation operates independently of the FDA and is intended “to help support and promote FDA’s regulatory science priorities.”[10:1] It fulfills this mission by collaborating with pharmaceutical and biotechnology companies on research programs, evidence generation and data gathering, as well as by analyzing and creating reports on the operations of the FDA.[24]
¶ Activities
The FDA has provided notable funding to:
¶ Freedom of information
The FDA publishes a list of documents frequently requested under Freedom of Information on a webpage titled "Electronic Reading Room."[26]
¶ External links
¶ Further reading
- November 30, 2023: "Conflicts of Interest: The U.S. Food and Drug Administration" on White Rose Intelligence, originally published by the Canadian Covid Care Alliance
What we do. (2018, March 28). Food and Drug Administration. http://archive.today/2023.02.07-154218/https://www.fda.gov/about-fda/what-we-do ↩︎
Office for Human Research Protections (OHRP). (2016, March 18). Food & Drug Administration. United States Department of Health and Human Services. http://archive.today/2020.08.11-183732/https://www.hhs.gov/ohrp/regulations-and-policy/regulations/fda/index.html ↩︎
FDA Commissioner. (2022, February 17). Food and Drug Administration.
https://web.archive.org/web/20230102065900/https://www.fda.gov/about-fda/fda-commissioner ↩︎ ↩︎When and why was FDA formed? (2018, March 28). Food and Drug Administration.
http://archive.today/2023.09.07-201200/https://www.fda.gov/about-fda/fda-basics/when-and-why-was-fda-formed ↩︎Swann, J. P. (2019, March 15). FDA’s origin. Food and Drug Administration.
https://web.archive.org/web/20230907201447/https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/fdas-origin ↩︎Center for Drug Evaluation and Research. (2022, August 27). Prescription Drug User Fee Amendments. Food and Drug Administration. https://web.archive.org/web/20230120033255/https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments ↩︎
LaMattina, J. (2018, June 28). The biopharmaceutical industry provides 75% of the FDA’s drug review budget. Is this a problem? Forbes. http://archive.today/2023.01.22-210302/https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/?sh=6c0ae09549ec ↩︎
Woodcock, J., & Junod, S. (2012, June 8). PDUFA lays the foundation: launching into the era of user fee acts. Food and Drug Administration. https://web.archive.org/web/20170722143500/https://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm305697.htm ↩︎
Chen, C. (2018, June 26). FDA repays industry by rushing risky drugs to market. ProPublica. http://archive.today/2021.08.27-203148/https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market ↩︎
110th Congress. (2007, September 27). Food and Drug Administration Amendments Act of 2007. U.S. Government Printing Office.
https://web.archive.org/web/20221005184742/https://www.govinfo.gov/content/pkg/PLAW-110publ85/html/PLAW-110publ85.htm ↩︎ ↩︎Office of the Commissioner. (2023, October 16). Non-Profit and Other MOUs. Food and Drug Administration. https://web.archive.org/web/20231028062431/https://www.fda.gov/about-fda/fda-memoranda-understanding/non-profit-and-other-mous ↩︎ ↩︎
Demasi, M. (2023, October 4). FDA ties with Gates Foundation. Substack. http://archive.today/2023.10.22-180219/https://maryannedemasi.substack.com/p/fda-ties-with-gates-foundation ↩︎
Fact sheet: FDA at a glance. (2019, October 18). Food and Drug Administration.
https://web.archive.org/web/20191203185354/https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance ↩︎FDA at a Glance (p. 2). (2020). Food and Drug Administration. https://web.archive.org/web/20221005204150/https://www.fda.gov/media/143704/download ↩︎
Fact sheet: FDA at a glance. (2022, August 17). Food and Drug Administration.
https://web.archive.org/web/20221005183101/https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance ↩︎Hinton, D. M. (2020, May 1). Remdesivir EUA Letter of Authorization. Food and Drug Administration. https://web.archive.org/web/20200501204823/https://www.fda.gov/media/137564/download ↩︎
Bhat, A., Browning-McNee, L. A., Ghauri, K., & Winckler, S. (2021). COVID-19 vaccine confidence project. Journal of the American Pharmacists Association, 62(1), P288-295.E2. https://doi.org/10.1016/j.japh.2021.06.006 ↩︎
Brunson, E. K., & Schoch-Spana, M. (2020). A social and behavioral research agenda to facilitate COVID-19 vaccine uptake in the United States. Health Security, 18(4). https://doi.org/10.1089/hs.2020.0106 ↩︎
Harkins, E. (2021, May 6). Re: BLA 125742 – COVID-19 mRNA Vaccine (BNT162/PF-07302048) – Part 1 of the Original Submission – Rolling Biologics License Application (BLA) – Request for Priority Review Designation. Public Health and Medical Professionals for Transparency; Pfizer Global Regulatory Affairs. https://web.archive.org/web/20230122214616/https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_cover.pdf ↩︎
Gruber, M. F. (2020). Emergency Use Authorization (EUA) for an unapproved product review memorandum: Pfizer-BioNTech COVID-19 Vaccine/ BNT162b2. Food and Drug Administration. https://web.archive.org/web/20230803085800/https://www.fda.gov/media/144416/download ↩︎
Capobianco, A. (2022, July 13). Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted. Food and Drug Administration. https://web.archive.org/web/20220713201410/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted ↩︎
N3C - Projects. National COVID Cohort Collaborative. Retrieved June 2, 2024, from https://web.archive.org/web/20240602001129/https://covid.cd2h.org/projects/ ↩︎
Alliance for a Stronger FDA lobbying profile. (2022, July 22). OpenSecrets.
https://www.opensecrets.org/federal-lobbying/clients/summary?cycle=2021&id=D000046669 ↩︎Programs. Reagan-Udall Foundation. Retrieved January 13, 2023, from
https://web.archive.org/web/20230113233812/https://reaganudall.org/programs ↩︎Aeras Global TB Vaccine Foundation - Rockville, USA. Bionity. Retrieved May 12, 2023, from http://archive.today/2023.05.12-171636/https://www.bionity.com/en/associations/20656/aeras-global-tb-vaccine-foundation.html ↩︎
Office of Regulatory Affairs. (2023, May 22). Electronic Reading Room. Food and Drug Administration. https://web.archive.org/web/20230621191228/https://www.fda.gov/regulatory-information/freedom-information/electronic-reading-room ↩︎