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

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

Trajectories of Injectable Cancer Drug Costs After Launch in the United States

2018 ◽  
Vol 36 (4) ◽  
pp. 319-325 ◽  
Author(s):  
Noa Gordon ◽  
Salomon M. Stemmer ◽  
Dan Greenberg ◽  
Daniel A. Goldstein
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Drug Costs ◽  
Cancer Drug ◽  
Steady Increase ◽  
Drug Prices ◽  
The Us ◽  
The Mean ◽  
Over Time

Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, −14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, −16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.

Present Status of Supplemental Application Submission in USFDA

2018 ◽  
Vol 9 (3) ◽  
Author(s):  
Verma S ◽  
Misri P ◽  
Yashwant . ◽  
Haque A
Keyword(s):  
United States ◽  
Drug Administration ◽  
Present Status ◽  
Drug Product ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
United States Food ◽  
States Food ◽  
Year 2000

Objective: In order to reach to the market, a drug product has to undergo various phases of scrutiny assuring its quality, safety and efficacy. Once the experimental drug promises its safety, efficacy and quality it is permitted to be marketed by the regulator. The drug is still present under surveillance for possibility of any adverse drug reaction or any other alteration or a new indication. If any modification is to be done, then the applicant/sponsor needs to file a supplemental application. This article provides information about present status of supplemental new drug application submitted and approved to the United States food and drug administration. Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000 to 2016. The data has been segregated and statistically analyzed using ANOVA on the basis of different categories of approved applications. Results: As per the analysis, from the year 2000 to 2016, a total of 69,585 applications was filed to USFDA, amongst which 9499 were original applications and 60,086 were supplemental applications.

scholarly journals Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings

JAMA ◽  
2006 ◽  
Vol 295 (16) ◽  
pp. 1921 ◽  
Author(s):  
Peter Lurie ◽  
Cristina M. Almeida ◽  
Nicholas Stine ◽  
Alexander R. Stine ◽  
Sidney M. Wolfe
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflict Of Interest ◽  
Food And Drug Administration ◽  
Financial Conflict ◽  
Drug Advisory Committee

scholarly journals Anesthetic and Analgesic Drug Products Advisory Committee Activity and Decisions in the Opioid-crisis Era

2020 ◽  
Vol 133 (4) ◽  
pp. 740-749 ◽  
Author(s):  
Ronald S. Litman
Keyword(s):  
United States ◽  
Advisory Committee ◽  
Drug Administration ◽  
Drug Product ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Analgesic Drug ◽  
Drug Products ◽  
United States Food

The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug’s perceived benefit–risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit–risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics.

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