Genevieve Pham-Kanter publishes on fCOI in FDA Advisory Committees

September 11, 2014

Fellow Genevieve Pham-Kanter's research on voting biases in the FDA was published this month in The Milbank Quarterly.

With the implementation of the Sunshine Act this fall, information about gifts and payments to physicians and hospitals from pharmaceutical and medical device companies will be available in a federal database. This spotlight on physician-industry relationships inevitably raises questions about conflicts of interest and their impact on physician decision making. Pham-Kanter's study examines the potential for financial conflicts of interest to influence advisory committee members of the Food and Drug Administration during the drug approval process and found that there seems to be a voting bias when experts have exclusive financial ties to firms but, surprisingly, not when they have multiple ties.

The study looks at 15 years of meetings and almost 16,000 votes from approximately 380 meetings of FDA Center for Drug Evaluation and Research advisory committee members. This important article is the result of research sponsored by the Edmond J. Safra Center for Ethics.