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# FDA Animal Antibiotic Concept Paper ‘Substantially Flawed’: Pew
- URL: https://www.fdaweb.com/fda-animal-antibiotic-concept-paper-substantially-flawed-pew/
- Published: 2021-05-25T12:00:00.000Z
- Updated: 2026-09-14T17:00:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149398

The Pew Charitable Trusts says an FDA concept paper, *Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper*, “is substantially flawed and will require significant revision.” In a just-released 4/12 comment [letter](https://downloads.regulations.gov/FDA-2016-D-2635-2610/attachment%5F1.pdf?ref=fdaweb.com), Pew says the agency should carefully consider the comments and feedback it receives and consider holding a public meeting to give stakeholders a platform to continue the dialog.

The letter raises these issues: 

- the agency’s proposed standards for targeted durations of use are poorly defined and unbounded;
- the framework fails to provide the guidance necessary to curb long-term antibiotic use; and
- the proposed timeline for implementation is too long.