Dr. Angela Fisher Selected to Deliver Oral Remarks at FDA Public Hearing on the Future Therapeutic Use of Psychedelic Drugs

Washington D.C., September 9, 2026 (Newswire.com) - Dr. Angela Fisher, clinical psychologist, founder of Bionic Bloom and the Neurodivergent Empowerment Institute, and creator of Empowerment-Based Integrated Treatment (EBiT), has been selected to deliver in-person oral public comments at the U.S. Food and Drug Administration's "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs" Public Hearing on September 14, 2026, at the FDA's White Oak Campus in Silver Spring, Maryland.

The FDA received more than 200 requests to present oral comments and offered speaking slots to fewer than half of those requesting to participate.

Fisher plans to use her remarks to address a problem she believes will become increasingly important as psychedelic medications move from clinical trials into ordinary healthcare: the patients who will receive these treatments in the real world frequently do not resemble the patients who qualify for the research used to establish their safety and efficacy.

"Clinical trials are intentionally guarded," Fisher said. "Researchers need to control variables, protect participants and establish whether a treatment works. But the real world is not a clinical trial. Autism comes back. ADHD comes back. OCD, trauma, chronic illness, multiple medications and complicated psychiatric histories all come back. Those are not unusual patients. Those are the patients."

Fisher argues that restrictive research protocols should not automatically become the permanent architecture of psychedelic healthcare.

"The clinical trial should teach us how to create safe care," Fisher said. "It should not become the care."

From Research Protocol to Real-World Medicine

FDA finalized its guidance for clinical investigations of psychedelic drugs in July 2026 as interest grows in psychedelic medicines for serious mental health conditions.

Fisher believes the next challenge is determining how those treatments can be implemented safely without creating a system so resource-intensive that psychedelic medicine becomes financially inaccessible to most patients.

Research protocols may include highly restrictive eligibility requirements, prolonged administration sessions, extensive staffing, controlled environments and intensive monitoring. Those safeguards can be appropriate for answering research questions, Fisher said, but their necessity in routine practice should be evaluated rather than assumed.

"If we simply reproduce the clinical trial in every treatment room, we risk creating psychedelic medicine that is technically available but practically unaffordable," Fisher said. "Safety and access should not be competing goals. The intensity of care should follow the actual risk of the patient, the medication, the dose, the route and the clinical situation."

Fisher plans to advocate for risk-stratified psychedelic care, in which patients with greater medical or psychiatric complexity receive greater clinical support rather than requiring the highest-intensity treatment model for every patient.

Training for an Episode of Care, Not Just a Psychedelic Session

Fisher will also urge the field to reconsider how psychedelic facilitators are trained.

Rather than focusing primarily on what happens while a patient is under the acute effects of a psychedelic, she proposes competency across the entire episode of care:

Prepare. Facilitate. Anticipate. Integrate.

Preparation should teach providers to understand the individual before altering consciousness, including psychiatric and medical history, medications, trauma responses, sensory needs, communication differences, expectations and how that person expresses distress.

During treatment, providers should be able to distinguish expected psychedelic phenomena from panic, dissociation, sensory overload, trauma activation, psychiatric destabilization or medical emergencies and understand when intervention is necessary.

Training must also address what can happen after the acute drug effects have ended, including emotional vulnerability, insomnia, activation, obsessive rumination, dissociation, changes in suicidality and other forms of delayed destabilization.

Fisher considers integration one of the most consequential components of psychedelic treatment.

"The psychedelic experience is not the outcome," Fisher said. "The question is what happens to that human being afterward. Did their relationships improve? Did they return to work? Are they functioning better? Did something emerge that now requires treatment? Did an insight actually translate into a change in their life?"

"We should not certify someone simply because they know how to get a patient safely through several hours of altered consciousness. We should train them to care for the person who wakes up the next morning."

Challenging Psychedelic Exceptionalism and Stigma

Fisher also intends to address the unusual stigma surrounding psychedelic medicines.

Modern psychedelic clinical research appropriately uses stringent safeguards, but Fisher cautions that those procedures may unintentionally reinforce the cultural perception that psychedelic substances require extraordinary containment simply because they are psychedelics.

"These substances are not new to humanity," Fisher said. "Some have histories of traditional human use extending thousands of years. That history does not make them risk-free, and modern scientific investigation is essential. But it should remind us to approach risk proportionally rather than allowing decades of stigma to dictate the future structure of care."

She argues that the emerging regulatory model should combine the strengths of controlled research with longitudinal real-world evidence.

"When a complex patient responds differently, we should not simply call them an outlier," Fisher said. "We should learn from them. Instead of treating comorbidity only as a confounder, we should treat it as a clinical variable worth studying."

Fisher is advocating for broader pragmatic research, real-world outcome registries and longitudinal collection of data that includes diagnoses, medication use, adverse responses, functional outcomes, quality of life and durability of improvement.

"We have an extraordinary opportunity right now," Fisher said. "We can build a model that respects the science without inheriting every limitation of the research environment. We can protect patients without frightening them, train clinicians without creating unnecessary barriers to practice, and make psychedelic medicine rigorous without making it a boutique treatment available only to people who can afford extraordinary levels of staffing."

"The real-world application of psychedelic medicine needs to be designed for the real world."

About Dr. Angela Fisher

Angela Fisher, PhD, is the founder of Bionic Bloom and the Neurodivergent Empowerment Institute, and creator of Empowerment-Based Integrated Treatment (EBiT). Her work focuses on neurodivergence, complex mental health presentations, integrative treatment and individualized approaches to psychedelic-assisted care.

Through her clinical and educational work, Fisher advocates for treatment models that prioritize patient autonomy, individualized care, functional outcomes and the inclusion of people whose complexity has historically excluded them from conventional research and treatment models.

About the FDA Public Hearing

The FDA's "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs" Public Hearing will be held September 14, 2026, from 12:30 p.m. to 4:30 p.m. ET at the FDA White Oak Campus in Silver Spring, Maryland, with virtual participation also available.

The hearing will address provider training and credentialing, patient safety, access, and best practices for data collection and standardization related to the potential future therapeutic use of psychedelic drug products in supervised and supportive settings.

Media Contact:
Bionic Bloom
Ella@bionicbloom.org

SOURCE: Bionic Bloom

Source: Bionic Bloom