In the Press
January 5, 2023

Data Integrity Fallout: Sponsors Risk Reputational Damage, Negative Impacts On Other Research (Pink Sheet)

Biopharma manufacturers whose clinical trials are marked by data integrity concerns must navigate a host of potentially negative consequences. During a panel discussion at the Food and Drug Law Institute’s recent Enforcement, Litigation and Compliance Conference, an FDA official and industry attorneys highlighted recent findings of clinical research misconduct by the Department of Health and Human Services’ Office of Research Integrity (ORI). Julie Tibbets, chair of the FDA practice in Washington, DC, reviewed recent ORI findings of research misconduct. “While ORI is focused on applying its administrative tools in the case of PHS-funded research activities, industry should take note where these activities or actions are occurring and what relationships they might have with planned research, past research or upcoming research that involves any of these staff and think about what it might mean for them,” she said while speaking with Pink Sheet