2:30pm - 3:30pm (CDT) | 3212.0 - Examining industry relationships among public stakeholders at FDA user fee meetings: A mixed-methods analysis

Session: ECP Poster 3

Program: Early-Career Professional

Presenter: Aneri Suthar, MPH

Abstract

This study examines industry relationships among public stakeholders at FDA user fee meetings since 2013 to demonstrate that a substantial majority of these stakeholders have direct financial ties to pharmaceutical industry, which shape their regulatory perspectives. These stakeholders' official interactions with FDA through user fee meetings contribute to regulatory approval processes being increasingly biased towards industry. Previous studies of Prescription Drug User Fee Act (PDUFA) reauthorization bills, which authorize these meetings, have shown that the legislative language allows for changes including relaxed limits on industry communications, additional required interactions between industry and FDA, and permission for industry to promote off-label uses to providers, payors, and federal and state agencies. This has led to concerns expressed by policymakers and patient advocates regarding the influence of the pharmaceutical industry over the FDA in public health regulatory decision making.

We have analyzed publicly available data on public stakeholders present at meetings during the past three PDUFA reauthorization cycles. We have looked at attendance numbers at meetings, public comments submitted, and financial statement forms documenting organizations’ yearly revenue and funding sources to determine ties to industry. Through comparing the frequency by which FDA convenes with public stakeholders and industry groups, determining whether public stakeholders themselves have financial ties to the pharmaceutical industry, and examining public stakeholders’ remarks and presentations at meetings, we have been able to determine notable alignment between public stakeholders' and industry members' positions on regulatory issues, demonstrating an increased bent towards industry in FDA user fee meetings over the last decade.