Speakers press FDA to standardize adverse‑event definitions and monitor real‑world risks

Multiple speakers at the FDA hearing stressed that approval alone will not define patient safety in real-world settings and called for clear, standardized methods to capture adverse events.

Odetta Hauke (regulatory affairs consultant) highlighted cardiac concerns and the need for standardized pre‑treatment cardiac risk assessment and reporting. Edward Jacobs (Oxford) told the panel that trial data with intensive safeguards still showed severe events for a small percentage of participants and warned that real‑world risk may be underestimated: "Even with the safeguards, 4% of participants with pre-existing conditions experienced severe events," he said.

Speakers also raised sexual misconduct and professional boundary risks. Genesee Herzberg of the Psychedelic Therapy Alliance said the field has seen ethical violations and sexual misconduct by several prominent therapists and urged certifying bodies to require ethics training and oversight: "WE'RE APPALLED BY THE ETHICAL VIOLATIONS AND SEXUAL MISCONDUCT BY SEVERAL PROMINENT PSYCHEDELIC THERAPISTS," she said.

Commenters recommended a standardized glossary and criteria set for adverse events (analogous to oncology's CTCAE), long‑term follow‑up in registries, and predefined review points to relax or tighten safeguards as postmarket evidence accumulates.