CONTEXT: The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. METHODS: The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior. FINDINGS: Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). CONCLUSIONS: There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.
CONTEXT: The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. METHODS: The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior. FINDINGS: Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). CONCLUSIONS: There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.
Authors: Kevin P Weinfurt; Mark A Hall; Michaela A Dinan; Venita DePuy; Joëlle Y Friedman; Jennifer S Allsbrook; Jeremy Sugarman Journal: J Gen Intern Med Date: 2008-04-02 Impact factor: 5.128
Authors: Eric G Campbell; Russell L Gruen; James Mountford; Lawrence G Miller; Paul D Cleary; David Blumenthal Journal: N Engl J Med Date: 2007-04-26 Impact factor: 91.245
Authors: Camilla Hansen Nejstgaard; Lisa Bero; Asbjørn Hróbjartsson; Anders W Jørgensen; Karsten Juhl Jørgensen; Mary Le; Andreas Lundh Journal: Cochrane Database Syst Rev Date: 2020-12-08
Authors: Camilla H Nejstgaard; Lisa Bero; Asbjørn Hróbjartsson; Anders W Jørgensen; Karsten J Jørgensen; Mary Le; Andreas Lundh Journal: BMJ Date: 2020-12-09
Authors: James Andrew Smith; Roxanna E Abhari; Zain Hussain; Carl Heneghan; Gary S Collins; Andrew J Carr Journal: BMJ Open Date: 2020-10-14 Impact factor: 2.692