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Research Letter
May 2, 2017

Association of Appearance of Conflicts of Interest With Voting Behavior at FDA Advisory Committee Meetings—A Cross-sectional Study

Author Affiliations
  • 1Office of Public Health Strategy and Analysis, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland
  • 2Office of Special Medical Programs, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. Published online May 2, 2017. doi:10.1001/jamainternmed.2017.1917

To ensure objectivity on the 49 advisory committees (ACs) of the US Food and Drug Administration (FDA), the FDA reviews disclosure statements submitted by members for 2 potentially disqualifying types of financial conflict of interest (COI): “section 208 conflicts” (regulated under 18 USC §2081) and, for those without section 208 conflicts, “section 502 conflicts” (regulated under 5 CFR §2635.5022). While section 208 conflicts are created by current financial interests, section 502 conflicts are typically created by past financial interests or personal and business relationships that could create the appearance of a conflict. For both, the FDA may either exclude the individual from participation or allow participation when permitted by statute. The FDA publicly discloses section 208 conflicts3 but not section 502 conflicts and has recently requested comments about whether these conflicts should be publicly disclosed.4,5

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