Dr. Angela Fisher to Present at FDA Hearing on Psychedelic Drugs
News related to:Bionic Bloom · 2 min read
Dr. Angela Fisher, the founder of Bionic Bloom and the Neurodivergent Empowerment Institute, has been selected to deliver oral remarks at the U.S. Food and Drug Administration’s (FDA) public hearing on the future therapeutic use of psychedelic drugs. The hearing, scheduled for September 14, 2026, at the FDA’s White Oak Campus in Silver Spring, Maryland, aims to address critical issues in the transition from clinical research to real-world care.
Fisher’s selection among over 200 applicants underscores the importance of her expertise in the field. She plans to advocate for a balanced approach to the implementation of psychedelic medicines, highlighting the need to move from research protocols to more practical and accessible models.
“Clinical trials are intentionally controlled,” Fisher explained. “But the real world is not a clinical trial. Patients who receive these treatments often have complex histories and varying needs. These patients are not outliers; they are the norm.”
Her presentation will focus on developing a competency-based model for psychedelic medicine, emphasizing risk stratification. Fisher argues that treatment intensity should follow the actual risk of the patient, the medication, the dose, and the clinical situation. She advocates for training that covers the entire episode of care, from preparation to integration, rather than just the acute effects of the psychedelic experience.
“Safety and access should not be competing goals,” Fisher said. “We should not reproduce the clinical trial in every treatment room. Instead, we should build a model that respects the science without inheriting every limitation of the research environment.”
During her remarks, Fisher will also address the stigma surrounding psychedelic medicines. She emphasizes the importance of considering the historical use of these substances and implementing a more proportional approach to risk assessment.
The FDA’s public hearing will also cover key topics such as provider training and credentialing, patient safety, access, and best practices for data collection and standardization. Fisher’s input is expected to play a significant role in shaping the future of psychedelic drug therapy.
“Bionic Bloom is committed to empowering individuals through innovative and evidence-based treatments,” said Fisher. “Our approach prioritizes patient autonomy, individualized care, and functional outcomes. We believe that by working closely with regulatory bodies, we can ensure that psychedelic medicine is available to those who need it most.”
In recent developments, the FDA finalized its guidance for clinical investigations of psychedelic drugs in July 2026. This guidance aims to address the growing interest in these medicines for serious mental health conditions. Fisher’s presentation at the hearing is seen as a crucial step in navigating the complexities of transitioning these treatments from research to real-world application.
Bionic Bloom’s focus on neurodivergence and complex mental health presentations positions the organization as a key player in the ongoing discourse around psychedelic-assisted care. Fisher’s advocacy for a more inclusive and practical model of care is likely to influence future regulatory decisions and clinical practices.