Financial Conflicts of Interest at FDA Drug Advisory Committee Meetings

2018 ◽  
Vol 48 (2) ◽  
pp. 10-13 ◽  
Author(s):  
Michael J. Hayes ◽  
Vinay Prasad
Keyword(s):  
Advisory Committee ◽  
Conflicts Of Interest ◽  
Drug Advisory Committee ◽  
Financial Conflicts Of Interest

Fr084 CHARACTERISTICS AND CONFLICTS OF INTEREST AT FOOD AND DRUG ADMINISTRATION GASTROINTESTINAL DRUG ADVISORY COMMITTEE MEETINGS

2021 ◽  
Vol 160 (6) ◽  
pp. S-212-S-213
Author(s):  
Rishad Khan ◽  
Karam Elsolh ◽  
Nikko Gimpaya ◽  
Michael A. Scaffidi ◽  
Rishi Bansal ◽  
...  
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Drug Advisory Committee

scholarly journals Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0252155
Author(s):  
Rishad Khan ◽  
Karam Elsolh ◽  
Nikko Gimpaya ◽  
Michael A. Scaffidi ◽  
Rishi Bansal ◽  
...  
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
Primary Study ◽  
Drug Advisory Committee ◽  
Univariate Analyses ◽  
Over Time

Introduction The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations. Methods In this cross-sectional study, all publicly available GIDAC meetings where proposed medications were voted on were included. Data were collected regarding indications, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively. Results Thirty-four meetings with 476 individual votes from 1998–2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved >1 primary study (n = 27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with fewer COI in 2006–2010, 2011–2015, and 2016–2020 compared to 1996–2000 and 2001–2005 (p<0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p>0.05 for all univariate analyses). Conclusions The GIDAC reviewed 34 proposals from 1998–2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC’s prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations.

scholarly journals A89 CHARACTERISTICS AND CONFLICTS OF INTEREST AT FOOD AND DRUG ADMINISTRATION GASTROINTESTINAL DRUG ADVISORY COMMITTEE MEETINGS

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 60-62
Author(s):  
R Khan ◽  
K Elsolh ◽  
N Gimpaya ◽  
M A Scaffidi ◽  
R Bansal ◽  
...  
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
Primary Study ◽  
Drug Advisory Committee ◽  
Univariate Analyses ◽  
Over Time

Abstract Background The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. Aims To analyze FDA GIDAC meetings and characteristics that predict recommendations. Methods This was a cross-sectional study of all publicly available GIDAC meetings where proposed medications were voted on from 1998–2018. Data were collected on individual meetings and individual voting members at meetings. Predefined predictor variables included type of medication, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively. Results Thirty-four meetings with 476 individual votes from 1998–2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved &gt;1 primary study (n=27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with more COI in 1996–2000 and 2001–2005 compared to 2006–2010, 2011–2015, and 2016–2020 (p&lt;0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p&gt;0.05 for all univariate analyses). Conclusions The GIDAC reviewed 34 proposals from 1998–2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC’s prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations. Funding Agencies None

scholarly journals A161 PREVALENCE OF FINANCIAL CONFLICTS OF INTEREST (FCOI) AMONG PROPENSITY-SCORE MATCHED RETROSPECTIVE STUDIES EVALUATING BIOLOGIC THERAPEUTICS FOR IBD

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 168-170
Author(s):  
K Elsolh ◽  
D Tham ◽  
M A Scaffidi ◽  
R Bansal ◽  
J Li ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Retrospective Studies ◽  
Conflicts Of Interest ◽  
Cochrane Library ◽  
High Burden ◽  
Real World Evidence ◽  
Full Text Retrieval ◽  
Financial Conflicts Of Interest ◽  
Matched Comparison

Abstract Background Inflammatory Bowel Disease (IBD) studies have commonly relied on real-world evidence to evaluate different therapies. An emerging idea has been the use of propensity score matching as a statistical method to account for baseline characteristics in IBD patients. In retrospective studies, propensity score matching of patients helps reduce treatment assignment bias and mimic the effects of randomization. Recently, propensity-score matching has become an important tool in IBD studies comparing biologic therapeutics. Biologic medications are among the highest-grossing drugs worldwide, and their pharmaceutical producers make considerable payments to physicians to market them. In spite of this, there is a lack of evidence examining the role of undue industry influence among propensity-score matched comparative studies evaluating biologic therapeutics for IBD. Aims Given the documented association between IBD biologics and FCOI, we hypothesize a high burden of FCOI in propensity-score matched studies. The aim of this study was to evaluate the prevalence of disclosed & undisclosed financial conflicts of Interest (FCOI) in propensity-score matched comparison studies evaluating biologics for IBD. Methods We developed & ran a librarian-reviewed systematic search on EMBASE, MEDLINE, and Cochrane Library databases for all propensity-score matched retrospective studies comparing biologics for the treatment of IBD. Full-text retrieval & screening was performed on all studies in duplicate. 16 articles were identified. Industry payments to authors were only considered FCOI if they were made by a company producing a biologic that was included in the comparison study. Disclosed FCOI were identified by authors’ interests disclosures in full-texts. Any undisclosed FCOI among US authors were identified using the Centre for Medicare and Medicaid Services (CMS) Open Payments Database, which collects industry payments to physicians. Results Based on a preliminary analysis of 16 studies, there was at least one author with a relevant FCOI in 14 (88%) of the 16 studies. 14 studies (88%) had at least one disclosed FCOI, while 6 studies (37.5%) had at least one undisclosed FCOI. Among studies with disclosed FCOI, a mean of 40.2% (SD = 23.4%) of authors/study reported FCOI. Among studies with undisclosed FCOI, a mean of 18.8% (SD = 7.0%) of authors/study reported FCOI. The total dollar value of FCOIs was $1,974,328.3. The median conflict dollar value was $5,576.6 (IQR: $321.6 to $36,394.9). Conclusions We found a high burden of undisclosed FCOI (37.5%) among authors of propensity-score matched studies evaluating IBD biologics. Given the potential for undue industry influence stemming from such payments, authors should ensure better transparency with industry relationships. Funding Agencies None

Sign in / Sign up

Export Citation Format

Share Document