Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Correspondence
  • Published:

The limits of acceptable political influence over the FDA

Nature Medicine volume 27, pages 188–190 (2021)Cite this article

Subjects

Access through your institution
Buy or subscribe

To the Editor — Extensive involvement of the White House in decision-making about the COVID-19 pandemic by the US Food and Drug Administration (FDA) has renewed attention to questions about the agency’s independence1. Resultant calls to ‘follow the science’ and avoid ‘politicizing’ the FDA are rooted in legitimate concerns, but in the context of this pandemic, the relationship among science, values and politics has often been oversimplified. The FDA cannot make decisions on the basis of science alone2, and political considerations sometimes do have a role to play. Rather than redesigning the FDA as an independent agency, which risks sacrificing too much democratic accountability, it is preferable to protect the FDA’s integrity by drawing a line between its broad policy decisions, which elected and appointed officials may appropriately influence, and decisions about specific applications before the agency, which should be shielded from such influence. Regardless of who occupies the White House, clarifying these issues remains important for the FDA’s future.

Despite the extreme nature of the science-versus-politics dichotomy that has emerged in the wake of the FDA’s response to COVID-19, agency decisions necessarily involve both scientific judgments and value judgments3. For example, FDA policymaking through regulations and guidance clarifies the types of scientific evidence the agency will rely on and how much it will demand, but it also illuminates how the agency intends to balance important tradeoffs in certainty, risk and benefit. The FDA’s approval and authorization decisions for specific products similarly are informed by data about safety and efficacy, but the agency must also balance normative considerations about speed and certainty in light of disease severity and medical need.

This is a preview of subscription content, access via your institution

Access options

Access through your institution

Buy this article

  • Purchase on SpringerLink
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Facher, L. STAT https://www.statnews.com/2020/08/27/trump-has-launched-an-all-out-attack-on-the-fda-will-its-scientific-integrity-survive/ (27 August 2020).

  2. Van Doren, P. CATO Institute https://www.cato.org/publications/pandemics-policy/when-how-we-should-trust-science?queryID=0bb3779607a903f1bb72c41f1ef4aaef (15 September 2020)

  3. Adashi, E. Y., Rajan, R. S. & Cohen, I. G. Science 364, 628–631 (2019).

    Article  CAS  Google Scholar 

  4. US Department of Health and Human Services. https://www.hhs.gov/about/news/2020/09/20/hhs-statement-on-regulatory-process.html (2020).

  5. 21 US Code § 355.

  6. Vought, R.T. https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-14.pdf (11 April 2019)

  7. Carpenter, D. Nature 485, 169–170 (2012).

    Article  CAS  Google Scholar 

  8. Califf, R. et al. Washington Post https://www.washingtonpost.com/opinions/2020/09/29/former-fda-commissioners-coronavirus-vaccine-trump/ (29 September 2020).

  9. Rubinstein Reiss, D. STAT https://www.statnews.com/2020/11/03/should-fda-be-independent/ (2020).

  10. Sunstein, C.R. & Vermeule, A. New York Times https://www.nytimes.com/2020/09/15/opinion/us-government-constitution.html (15 September 2020).

  11. Troy, D., Mendelson, D. & Beier, D. Health Affairs Blog https://www.healthaffairs.org/do/10.1377/hblog20190312.542301/full/ (19 March 2019).

  12. Cancryn, A. & Owermohle, S. POLITICO https://www.politico.com/news/2020/11/03/health-agencies-resist-trump-civil-service-executive-order-433892 (3 November 2020).

  13. Sharfstein, J. Nature 585, 161 (2020).

    Article  CAS  Google Scholar 

  14. Edwards, K. T. Food Drug Law J. 72, 406–450 (2017).

    Google Scholar 

  15. Baker, S. The Hill https://thehill.com/policy/healthcare/197825-sebelius-overrules-fda-blocks-access-to-plan-b (7 December 2011).

Download references

Acknowledgements

We thank F.G. Miller, J. Darrow and I.G. Cohen for insight on the topics addressed in this article.

Author information

Authors and Affiliations

  1. Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    Holly Fernandez Lynch, Steven Joffe & Matthew S. McCoy

Authors
  1. Holly Fernandez Lynch
    View author publications

    Search author on:PubMed Google Scholar

  2. Steven Joffe
    View author publications

    Search author on:PubMed Google Scholar

  3. Matthew S. McCoy
    View author publications

    Search author on:PubMed Google Scholar

Corresponding author

Correspondence to Holly Fernandez Lynch.

Ethics declarations

Competing interests

H.F.L. reports funding from The Greenwall Foundation. S.J. previously received research funding through the University of Pennsylvania Perelman School of Medicine from Pfizer.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Fernandez Lynch, H., Joffe, S. & McCoy, M.S. The limits of acceptable political influence over the FDA. Nat Med 27, 188–190 (2021). https://doi.org/10.1038/s41591-020-01200-w

Download citation

  • Published:

  • Issue date:

  • DOI: https://doi.org/10.1038/s41591-020-01200-w

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research