BioCentury’s FDA survey reflects an industry in distress

If one word captures biopharma’s most widespread concern about FDA it is “inconsistency.” From those who are caustically critical of the agency to those who are supportive of change and new approaches, the instability in FDA leadership and the uncertainty that dog its policies and decisions are major overhangs on the entire industry heading into 2026, according to BioCentury’s 2025 FDA survey.

FDA staff receive high marks for effort, but respondents say those efforts are being undercut by senior leaders whose decisions appear driven by a political agenda rather than science...