Revisiting Financial Conflicts of Interest in FDA Advisory Committees

September 2014 | Genevieve Pham-Kanter | Original Investigation

Policy Points:

  • FDA Center for Drug Evaluation and Research advisory committee members who have financial ties solely to the firm sponsoring the drug under review are more likely to vote in ways favorable to the sponsor.
  • Committee members who serve on advisory boards for sponsoring firms show particularly strong pro-sponsor bias.
  • Contrary to conventional wisdom, committee members who have financial ties to many different firms do not, on average, show pro-industry bias in their voting behavior.

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 relation- ships (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.

Author(s): Genevieve Pham-Kanter

Keywords: conflict of interest, food and drug administration, drug approval

Download the study

Read on Wiley Online Library

Volume 92, Issue 3 (pages 446–470)
DOI: 10.1111/1468-0009.12073
Published in 2014