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# Praise for Proposed FDA Office of Patient Affairs
- URL: https://www.fdaweb.com/praise-for-proposed-fda-office-of-patient-affairs/
- Published: 2017-06-13T12:00:00.000Z
- Updated: 2026-09-14T22:29:01.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5138920

Stakeholders are praising FDA for proposing to create an Office of Patient Affairs (OPA). For example, the Biotechnology Innovation Organization (BIO) [says](https://www.regulations.gov/document?D=FDA-2017-N-0455-0054&ref=fdaweb.com) it “applauds the agency for its continued commitment to advancing the science of integrating patient perspectives into drug development and regulatory review processes. We also support FDA’s proposed establishment of a central Office of Patient Affairs to provide a more transparent, accessible, and positive experience for patient communities. Such a centralized office could serve to support other offices that engage with patients and their advocates on matters pertaining to medical products. There is a need for patient engagement infrastructure that benefits all Centers and OPA should be ideally situated to take on this work.”

BIO cautions, however, that it is crucial that any of the activities conducted by OPA are designed to be additive to and not supplant crucial aspects of the PDUFA 6 agreement. “Specifically the provision that directs FDA to embed experts within the review divisions to facilitate development as well as use of patient-focused methods to inform drug development and regulatory decisions,” the comment letter says. “More information about how OPA would be ‘directly accountable to the medical product Centers through clear governance structures’ is needed to ensure that the objectives and activities directed by 21st Century Cures and PDUFA 6 are implemented. OPA should not divert crucial activities and resources away from the review divisions as they should retain overall responsibility for evaluating patient input.”

The Association of Clinical Research Organizations [says](https://www.regulations.gov/document?D=FDA-2017-N-0455-0019&ref=fdaweb.com) the “availability of a single point of entry for engagement with FDA through this Office may \[be\] particularly useful for individuals and smaller patient organizations that may lack the resources or expertise to successfully navigate the agency…. We support the proposal as an important element in the agency’s continuing efforts to facilitate patient knowledge of and engagement with the medical product development process.”

TransCelerate BioPharma [says](https://www.regulations.gov/document?D=FDA-2017-N-0455-0041&ref=fdaweb.com) it supports FDA’s objectives for the Office of Patient Affairs as well as the ongoing effort by FDA to enhance future patient (Caregiver) engagement by providing a more transparent, accessible, and robust experience for patient communities into the medical product development process.

Finally, the National Kidney Foundation [says](https://www.regulations.gov/document?D=FDA-2017-N-0455-0045&ref=fdaweb.com) it “previously advocated for expanded opportunities at FDA to include patient perspectives in decisions throughout the lifecycle of medical products, from patient development all the way through post-market regulations.” It lists a series of activities it would like OPA to undertake.