¶ Reagan-Udall Foundation for the Food and Drug Administration
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The Reagan-Udall Foundation for the Food and Drug Administration, sometimes referred to as the FDA Foundation, is an American non-profit organization based in Washington, D.C. It identifies itself as a public-private partnership.
It operates independently of the Food and Drug Administration (FDA), but was mandated by Congress "to help support and promote FDA's regulatory science priorities.”[1]
¶ History
The Reagan-Udall Foundation was established in 2007 by the United States Congress through the passage of the Food and Drug Administration Amendments Act of 2007.[1:1]
¶ COVID-19
In March 2020, at the request of the FDA, the Reagan-Udall Foundation partnered with Friends of Cancer Research to create the COVID-19 Evidence Accelerator.[2] It had a budget of $1,219,555 across 2020 and 2021.
One of the studies produced by the COVID-19 Evidence Accelerator was a meta-analysis evaluating the role of hydroxychloroquine and an antibiotic called azithromycin, both alone and in combination, as treatment for COVID-19. The investigators examined the use of these treatments in late stage disease, rather than its well-established use as an early treatment protocol.[3][4][5] The results were published on March 17, 2021, finding that the drugs had little benefit at any stage of treatment of COVID-19.[6]
¶ Vaccine Confidence Project
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.[7][8] 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.”
¶ Finances
Funding for the Reagan-Udall Foundation is made up of an annual $1.25 million budget provided by the FDA, with the remainder coming from grants, donations, research contracts, fundraising events and investment income. The Reagan-Udall Foundation’s annual budget nearly doubled over the COVID-19 period. In 2019, the Foundation’s reported revenue was just over $2.7 million.[9] This jumped to $4.9 million in 2020,[10] and to $5.5 million in 2021.[11] Thus, as of 2021, 77.3% of the Foundation’s grants came from industry or private philanthropic entities that have strong ties to industry.[12]
The foundation has received funding through sponsorships and donations from:[9:1][13][14]
- 5AM Ventures
- 505(b)(2) Platform
- AbbVie
- Adaptive Biotechnologies
- Aetion
- Aevi Genomic Medicine
- Alexandria Real Estate Equities
- Alnylam Pharmaceuticals
- Alston & Bird
- American Cancer Society
- American Society of Clinical Oncology
- Amgen
- Amicus Therapeutics
- AstraZeneca
- Bayer
- Bill & Melinda Gates Foundation
- Biogen
- Biotechnology Innovation Organization (BIO)
- Booz Allen Hamilton
- Bristol-Myers Squibb
- Brown-Hamburg Charitable Gift Fund
- Buchanan Ingersoll & Rooney PC
- Casdin Capital
- Celgene
- Commonwealth Fund
- CSL Behring
- Consumer Healthcare Products Association
- Deloitte
- Eli Lilly
- EQRx
- Explorations in Global Health (ExGloH)
- Flagship Pioneering
- Food and Drug Administration (FDA)
- Foundation Medicine
- Friends of Cancer Research
- FTI Consulting
- Genentech
- Gilead Sciences
- Glover Park Group
- GRAIL
- Greenleaf Health
- H3 Biomedicine
- Horizon Therapeutics
- Hyman, Phelps & McNamara
- Illumina
- Incyte
- Intra-Cellular Therapies
- Janssen
- Jewish Communal Fund
- J.M. Smucker Company
- Johnson & Johnson
- Kaiser Permanente
- Kellogg's
- Kraft Heinz
- Mark McLellan
- Medscape
- Merck
- Meyers Primary Care Institute
- MycoTechnology
- Nestlé
- Novartis
- One Medical Group
- Patient Centered Outcomes Research Institute
- PatientsLikeMe
- Pfizer
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Point32Health
- Rockefeller Foundation
- S2G Ventures
- Sanofi
- Sporos Bioventures
- Susan G. Komen
- Takeda Pharmaceuticals
- Teva
- Thermo Fisher Scientific
- Thrive Earlier Detection
- Ultragenyx Pharmaceutical
- USP
- Verily Life Sciences
- Vir Biotechnology
- WebMD
- Zydowsky Consultants
¶ Partners
Partners of the foundation include:[11:1][10:1]
- CVS Health
- Harvard Pilgrim Health Care Initiative
- HealthCore
- HealthPartners Institute
- Humana Healthcare Research
- Kaiser Permanente Washington Health Research Institute
- Marshfield Clinic Health System
- Marshfield Clinic Research Institute
- Meyers Health Care Institute
- Sutter Health
- Vanderbilt University Medical Center
¶ Grants
¶ External links
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 ↩︎ ↩︎
Home. COVID-19 Evidence Accelerator. Retrieved September 7, 2023, from
https://web.archive.org/web/20230907235240/https://evidenceaccelerator.org/ ↩︎@CovidAnalysis. HCQ for COVID-19: real-time analysis of all 551 studies. C19hcq: COVID-19 HCQ Treatment Analysis. Retrieved September 7, 2023, from https://c19hcq.org/ ↩︎
Tyson, B., Fareed, G., & Crawford, M. (2022). Overcoming the COVID-19 darkness: How two doctors successfully treated 7000 patients. Brian Tyson, M.D. and George C. Fareed, M.D. ↩︎
Leake, J., & McCullough, P. A. (2022). The courage to face COVID-19: Preventing hospitalization and death while battling the bio-pharmaceutical complex. Skyhorse Publishing. https://www.skyhorsepublishing.com/9781510776807/the-courage-to-face-covid-19/ ↩︎
Stewart, M., Rodriguez-Watson, C., Albayrak, A., Asubonteng, J., Belli, A., Brown, T., Cho, K., Das, R., Eldridge, E., Gatto, N., Gelman, A., Gerlovin, H., Goldberg, S. L., Hansen, E., Hirsch, J., Ho, Y.-L., Ip, A., Izano, M., Jones, J., & Justice, A. C. (2021). COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients. PLOS ONE, 16(3), e0248128. https://doi.org/10.1371/journal.pone.0248128 ↩︎
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 ↩︎
Annual Report 2019 (p. 23). (2019). Reagan-Udall Foundation. https://web.archive.org/web/20220712071448/https://reaganudall.org/sites/default/files/2022-02/Reagan-Udall_Annual Report 20219_final_corrected.pdf ↩︎ ↩︎
Annual Report 2020. (2020). Reagan-Udall Foundation for the FDA. https://web.archive.org/web/20220712065838/https://reaganudall.org/sites/default/files/2021-07/7-1-21_Reagan-Udall_AR.pdf ↩︎ ↩︎
Sigal, E. V., Winckler, S. C., & Califf, R. M. (2021). 2021 Annual Report. Reagan-Udall Foundation. https://web.archive.org/web/20220712045554/https://reaganudall.org/about-us/annual-reports/2021-annual-report ↩︎ ↩︎
Foley, K. E., & Cancryn, A. (2022, August 4). Clinton-era FDA commissioner to lead external review of key agency offices. Politico.
http://archive.today/2023.06.27-210118/https://www.politico.com/news/2022/08/04/fda-jane-henney-reagan-udall-00049977 ↩︎2018 Annual Report. (2018). Reagan-Udall Foundation. https://web.archive.org/web/20220712132051/https://reaganudall.org/about-us/annual-reports/2018-annual-report ↩︎
2017 Annual Report. (2017). Reagan-Udall Foundation. https://web.archive.org/web/20220712132141/https://reaganudall.org/about-us/annual-reports/2017-annual-report ↩︎