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# Politics Can’t Be Kept Out of FDA: Opinion
- URL: https://www.fdaweb.com/politics-cant-be-kept-out-of-fda-opinion/
- Published: 2021-01-19T12:00:00.000Z
- Updated: 2026-09-14T16:43:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148470

Three staff in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine of the University of Pennsylvania say FDA “cannot make decisions on the basis of science alone, and political considerations sometimes do have a role to play.” In an online [letter to the editor](https://www.nature.com/articles/s41591-020-01200-w?ref=fdaweb.com) of *Nature Medicine* the three caution against simply redesigning FDA as an independent agency because, they say, it risks sacrificing too much democratic accountability. They recommend protecting the agency’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,” the authors write, “clarifying these issues remains important for FDA’s future.”

The article says the dual nature of FDA decision-making means that it cannot avoid political considerations, which the authors define as governmental value judgments about competing goods and interests. They say the critical question is whether such value judgments should be left to FDA career scientists or whether, and to what extent, they legitimately may be influenced by a president’s administration.

The authors maintain that accepting that any administration should retain some ability to influence FDA is not to suggest that administration officials should have unfettered discretion to intervene.

They say the model reorganization they propose would ensure that FDA’s decisions remain accountable to public values while limiting the extent to which inexpert or conflicted political actors can influence those decisions. They propose a division of labor in which FDA career scientists can make unencumbered decisions about particular product applications, while elected and appointed officials have a role in broader policies to guide the staff decisions.

“In all cases,” the authors say, “application-level and policy-level decisions must align with the best scientific evidence, incorporate necessary expertise, be transparent, and advance FDA’s public health mission.”