PMID- 35749461 OWN - NLM STAT- MEDLINE DCOM- 20220628 LR - 20220716 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 17 IP - 6 DP - 2022 TI - Voting behavior during FDA Medical Device Advisory Committee panel meetings. PG - e0267134 LID - 10.1371/journal.pone.0267134 [doi] LID - e0267134 AB - OBJECTIVES: During premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval. The objective of this study is to assess the relationship, if any, between individual votes and Panel recommendations and: (1) the composition of Panels, specifically the expertise and demographic features of individual members; or (2) Panel members' propensity to speak during Panel deliberations. METHODS: This was a retrospective cohort study of routinely collected data from voting members of MDAC panels convened between January 2011 to June 2016 to consider premarket approval. Data sources were verbatim transcripts available publicly from the FDA. Number of words spoken, directionality of votes on device approval, profession, and demographics were collected. RESULTS: 658,954 words spoken by 536 members during 49 meetings of 11 Panels were analyzed. Based on multivariate analysis, biostatisticians spoke more (+373 words; P = 0.0002), and women (-187 words; P = 0.0184) and other non-physician voting members less (-213 words; P = 0.0306), than physicians. Speaking more was associated with abstaining (P = 0.0179), and with voting against the majority (P = 0.0153). Non-physician, non-biostatistician members (P = 0.0109), and those having attended more meetings as a voting member (P = 0.0249) were more likely to vote against approval. In bivariable analysis, unanimous Panels had a greater proportion of biostatisticians (mean 0.1580; 95% CI 0.1237-0.1923) than non-unanimous Panels (0.1107; 95% CI 0.0912-0.1301; p = 0.0201). CONCLUSIONS: Panelists likely to vote against the majority include non-physician, non-biostatisticians; experienced Panelists; and more talkative members. The increased presence of biostatisticians on Panels leads to greater voting consensus. Having a diversity of opinions on Panels, including in sufficient numbers those members likely to dissent from majority views, may help ensure that a diversity of opinions are aired before decision-making. FAU - Maisel-Campbell, Amanda AU - Maisel-Campbell A AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. AD - Department of Dermatology, Columbia University Medical Center, New York, NY, United States of America. FAU - Schlessinger, Daniel I AU - Schlessinger DI AD - Division of Dermatology, Washington University School of Medicine, St Louis, MO, United States of America. FAU - Yanes, Arianna F AU - Yanes AF AD - Department of Dermatology, University of Pennsylvania, Philadelphia, PA, United States of America. FAU - Veledar, Emir AU - Veledar E AD - Emory University School of Medicine, Atlanta, GA, United States of America. AD - Baptist Health South Florida, Miami, FL, United States of America. FAU - Reynolds, Kelly A AU - Reynolds KA AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. AD - University of Cincinnati College of Medicine, Cincinnati, OH, United States of America. FAU - Ibrahim, Sarah A AU - Ibrahim SA AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. FAU - Kang, Bianca Y AU - Kang BY AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. FAU - Anvery, Noor AU - Anvery N AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. FAU - Poon, Emily AU - Poon E AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. FAU - Alam, Murad AU - Alam M AUID- ORCID: 0000-0001-8752-3821 AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. AD - Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. AD - Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220624 PL - United States TA - PLoS One JT - PloS one JID - 101285081 SB - IM MH - *Advisory Committees MH - Consensus MH - Device Approval MH - Female MH - Humans MH - *Politics MH - Retrospective Studies MH - United States MH - United States Food and Drug Administration PMC - PMC9231736 COIS- The authors have declared that no competing interests exist. EDAT- 2022/06/25 06:00 MHDA- 2022/06/29 06:00 PMCR- 2022/06/24 CRDT- 2022/06/24 13:54 PHST- 2021/08/02 00:00 [received] PHST- 2022/04/01 00:00 [accepted] PHST- 2022/06/24 13:54 [entrez] PHST- 2022/06/25 06:00 [pubmed] PHST- 2022/06/29 06:00 [medline] PHST- 2022/06/24 00:00 [pmc-release] AID - PONE-D-21-24994 [pii] AID - 10.1371/journal.pone.0267134 [doi] PST - epublish SO - PLoS One. 2022 Jun 24;17(6):e0267134. doi: 10.1371/journal.pone.0267134. eCollection 2022.