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DTSTART:20241103T020000
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DESCRIPTION:Session : ECP Poster 3 Program : Early-Career Professional Pre
 senter: Aneri Suthar\, MPH Abstract This study examines industry relation
 ships among public stakeholders at FDA user fee meetings since 2013 to de
 monstrate that a substantial majority of these stakeholders have direct f
 inancial ties to pharmaceutical industry\, which shape their regulatory p
 erspectives. These stakeholders' official interactions with FDA through u
 ser fee meetings contribute to regulatory approval processes being increa
 singly biased towards industry. Previous studies of Prescription Drug Use
 r Fee Act (PDUFA) reauthorization bills\, which authorize these meetings\
 , have shown that the legislative language allows for changes including r
 elaxed limits on industry communications\, additional required interactio
 ns between industry and FDA\, and permission for industry to promote off-
 label uses to providers\, payors\, and federal and state agencies. This h
 as led to concerns expressed by policymakers and patient advocates regard
 ing the influence of the pharmaceutical industry over the FDA in public h
 ealth regulatory decision making. We have analyzed publicly available dat
 a 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 o
 rganizations’ yearly revenue and funding sources to determine ties to ind
 ustry. Through comparing the frequency by which FDA convenes with public 
 stakeholders and industry groups\, determining whether public stakeholder
 s themselves have financial ties to the pharmaceutical industry\, and exa
 mining public stakeholders’ remarks and presentations at meetings\, we ha
 ve been able to determine notable alignment between public stakeholders' 
 and industry members' positions on regulatory issues\, demonstrating an i
 ncreased bent towards industry in FDA user fee meetings over the last dec
 ade.\n\nSpeaker:\nAneri Suthar\, MPH\n\nAdmission:\nRegistrationFees: APH
 A Event Registration is Required\n\nDetails URL:\nhttps://medicine.yale.e
 du/event/examining-industry-relationships-among-public-stakeholders-at-fd
 a-user-fee-meetings/\n
DTEND;TZID=America/New_York:20241028T163000
DTSTAMP:20261030T150321Z
DTSTART;TZID=America/New_York:20241028T153000
GEO:44.970269;-93.273376
LOCATION:1301 2nd Avenue South\, Minneapolis\, MN\, United States
SEQUENCE:0
STATUS:Confirmed
SUMMARY:2:30pm - 3:30pm (CDT) | 3212.0 - Examining industry relationships 
 among public stakeholders at FDA user fee meetings: A mixed-methods analy
 sis
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