Association between Oncologic Drugs Advisory Committee (ODAC) members’ financial conflicts of interest (FCOIs) and recommendations for drug approval by the U.S. Food and Drug Administration (FDA).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 6582-6582
Author(s):  
Ariadna Tibau Martorell ◽  
Alberto Ocana ◽  
Bostjan Seruga ◽  
Arnoud J. Templeton ◽  
Agusti Barnadas ◽  
...  
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Drug Approval ◽  
Financial Conflicts Of Interest ◽  
The U.S

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

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

Sign in / Sign up

Export Citation Format

Share Document