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# Few ODAC Advisory Committee Questions Difficult: Study
- URL: https://www.fdaweb.com/few-odac-advisory-committee-questions-difficult-study/
- Published: 2025-07-23T12:00:00.000Z
- Updated: 2026-09-14T15:17:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159557

Researchers from the University of Pennsylvania and the University of Southern California say that members of the FDA Oncology Drugs Advisory Committee (ODAC) reported that very few questions posed by the agency for committee votes were difficult to answer. Writing in *JAMA Network Open*, the researchers [say](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2836759?widget=personalizedcontent&previousarticle=2775950&ref=fdaweb.com) there has been debate about the usefulness of committee votes, which may not capture substantive discussions or member uncertainty.

The authors say they reviewed ODAC transcripts from 1/2008 to 10/2022, analyzing type of voting question, whether members expressed difficulty in explanatory statements, and their articulated rationale for difficulty in voting if it was difficult.

During the sample period, the report says, ODAC convened 71 voting sessions, in which 230 scientific members, 45 patient representatives, and 12 consumer representatives participated in at least one vote on 83 questions. Of 1,021 member votes, it says, 990 votes included explanatory statements, with fewer than one in 10 statements indicating a difficult voting decision, without any discernable pattern by year.

“The most frequent rationales for difficulty were unconvincing *post hoc* analysis and unmet need statements,” the report says.

The authors say that as FDA contemplates reforms to the advisory committee process, the study results suggest that voting difficulty is not an independent reason to change binary voting. “Numerical voting, along a confidence scale or as an indication of strength of support, could offer more nuance but may be harder to interpret,” they say.