Informed Options Trading Before Fda Drug Advisory Committee Meetings

2021 ◽  
Author(s):  
Zekun Wu ◽  
Paul Borochin ◽  
Joseph Golec
Keyword(s):  
Advisory Committee ◽  
Drug Advisory Committee ◽  
Options Trading

scholarly journals Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs

2020 ◽  
Vol 25 (4) ◽  
pp. 145-146 ◽  
Author(s):  
Will Roberts ◽  
Samuel Jellison ◽  
Cole Wayant ◽  
Matt Vassar
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Company ◽  
Advisory Committee ◽  
Public Hearing ◽  
Conflicts Of Interests ◽  
Advisory Committees ◽  
Psychiatric Drugs ◽  
Drug Advisory Committee ◽  
Public Speakers ◽  
Positive Statement

The Psychopharmacologic Drug Advisory Committee (PDAC) is one of 33 advisory committees of the Food and Drug Administration (FDA). During committee meetings, an open public hearing takes place where speakers provide testimonies about the drug in question and are asked, not required, to disclose any conflicts of interests (COIs) before speaking. These speakers may present with COIs which include, but are not limited to, reimbursement for travel and lodging by the pharmaceutical company to attend the meeting; previous or current payments for consulting from the pharmaceutical company and compensation as a paid investigator in previously conducted clinical trials for the drug under review. Our study aimed to investigate the characteristics and COIs of public speakers at PDAC meetings of the FDA. We evaluated 145 public speakers at FDA committee meetings over a 10-year period. We found a total of 52 public speakers disclosed a COI with travel and lodging being the most prominent. Among these speakers, 82.4% provided a positive testimony regarding the psychiatric drug in question. Speakers who had the condition in question were not more likely to provide a positive statement than those who did not. Our results showed that disclosing a COI was associated with increased odds of public speakers providing a favourable testimony for the recommendation of psychiatric drugs. The implications of these findings are concerning since COIs have the potential to skew public speaker’s testimonies and persuade committee members to recommend a drug through emotionally charged tactics.

Applications for oncologic drugs — Lessons from the oncologic drug advisory committee

2012 ◽  
Vol 127 (1) ◽  
pp. S13
Author(s):  
I. Amanam ◽  
T. Kiet ◽  
N. Young-Lin ◽  
L. Chen ◽  
R. Brooks ◽  
...  
Keyword(s):  
Advisory Committee ◽  
Drug Advisory Committee

The association of relative survival benefit and approval of oncological drugs: An analysis of oncology drug advisory committee reviews.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 2582-2582
Author(s):  
Idoroenyi Usua Amanam ◽  
Austin Blake Gardner ◽  
Spencer L. James ◽  
Daniel Stuart Kapp ◽  
John K. Chan
Keyword(s):  
Advisory Committee ◽  
Survival Benefit ◽  
Relative Survival ◽  
Oncology Drug ◽  
Drug Advisory Committee

Public Speaker Characteristics at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel

2021 ◽  
Vol 223 ◽  
pp. 28-32
Author(s):  
Mostafa H. Khattab ◽  
Michael Weaver ◽  
Courtney Cook ◽  
Nicholas Kinder ◽  
Matt Vassar
Keyword(s):  
Advisory Committee ◽  
Drug Advisory Committee ◽  
Ophthalmic Drug

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
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