Students for Sensible Drug Policy

Students for Sensible Drug Policy (SSDP) is the largest youth-led grassroots network dedicated to replacing the War on Drugs with policies rooted in evidence, compassion, and human rights — policies that make sense.

Introduction and Guiding Principles

As the U.S. Food and Drug Administration (FDA) considers frameworks for the potential future therapeutic use of psychedelic drug products, SSDP respectfully urges the Agency to prioritize patient safety, meaningful access, informed consent, cultural competency, and patient dignity. Any future framework should be grounded in evidence, while recognizing that psychedelic substances have long and complex histories of human use, and that the emerging medical model does not exist in a cultural or historical vacuum.

Psychedelics are a diverse class of psychoactive compounds being investigated for their potential to treat serious mental health conditions, substance use disorders, pain, and many other conditions. Psychedelic compounds are currently being studied and used in investigational, state-regulated, or off-label clinical settings, for conditions including, but not limited to:

• Major Depressive Disorder (MDD)
• Post-Traumatic Stress Disorder (PTSD)
• Severe Existential Anxiety Disorder
• Substance Use Disorder (SUD)
• Cluster headaches and other migraine disorders

For many individuals, access to psychedelic drugs can be life-changing and life-saving. Research into psychedelic-assisted therapies is particularly important for people with serious conditions and unmet medical and behavioral health needs, including those for whom existing treatments have been ineffective, intolerable, or inaccessible.

As FDA considers potential future therapeutic models, SSDP recommends that the Agency prioritize patient safety, quality of care, and meaningful access in the development and implementation of any future treatment framework. SSDP also urges the Agency to avoid unnecessarily restrictive requirements that could make otherwise appropriate treatment practically inaccessible for patients who may benefit from these therapies.

Provider Training, Credentialing, and Standards of Care

Providers should receive appropriate and robust training designed to prepare them to safely support patients before, during, and after treatment. Training curricula should address, as appropriate to each provider’s role, physical and mental health screening, informed consent, managing challenging experiences, emergency procedures, trauma-informed care, cultural competency, and professional boundaries. Credentialing requirements should separately establish appropriate qualifications for each provider’s responsibilities and scope of practice.

At the same time, credentialing requirements should be proportionate to providers’ responsibilities and supported by evidence. FDA should avoid unnecessarily narrow requirements that restrict the number of qualified providers, increase costs, or make treatment inaccessible, particularly in rural and underserved communities. Where appropriate, training should be competency-based and recognize the distinct roles that medical professionals, mental health professionals, trained facilitators, peer-support providers, and other members of a multidisciplinary care team may play.
Patients should have access to a qualified, multidisciplinary team with clearly defined roles and responsibilities appropriate to the patient’s needs and the treatment being provided. Patient safety should remain central at every stage of care, including safeguards that recognize the heightened vulnerability and power dynamics that can arise during psychedelic experiences. Those safeguards should include clear standards for informed consent, physical contact, sexual and professional boundaries, reporting mechanisms, patient complaints, and accountability.

Provider training should also include meaningful cultural competency. Some psychedelic substances and practices involving them have long histories of traditional and Indigenous use that substantially predate contemporary Western medical interest. Without asking FDA to regulate religious, ceremonial, or other non-medical use, SSDP urges the Agency to ensure that the development of a medical framework does not erase this history or treat the contemporary clinical system as the sole source of relevant knowledge. Indigenous people, traditional knowledge holders, and communities with longstanding relationships to psychedelic substances should be meaningfully included in discussions concerning provider education, cultural competency, patient experience, and appropriate data collection.

Cultural competency is especially important where emerging clinical practices draw upon knowledge, concepts, terminology, or practices originating in Indigenous or traditional contexts. Providers should be trained to understand cultural differences in patients’ experiences and beliefs without pathologizing them, appropriating traditions, or presenting culturally specific practices as generic components of psychedelic medicine.

Meaningful and Equitable Access

SSDP recommends that FDA consider accessibility as an essential component of any future therapeutic model. Access to psychedelic-assisted therapy should account for patients’ geographic location, transportation needs, disabilities, language and cultural needs, financial circumstances, insurance coverage, and availability of qualified providers.

Access considerations should also account for eligibility and diagnostic criteria so that potentially beneficial treatment is not unnecessarily limited to patients with a narrow set of qualifying conditions. FDA should also consider the total cost and practical burden of obtaining treatment, including not only the direct cost of care but also transportation and travel, time away from work, childcare or other caregiving responsibilities, preparation and integration services, therapy, follow-up care, and other requirements associated with receiving treatment. Requirements for repeated in-person visits, lengthy observation periods, or multiple appointments can further increase these costs and burdens, particularly for rural patients, people with disabilities, people with limited financial resources, and people with significant family or employment obligations. Safety requirements should be evidence-based and no more burdensome than necessary to address demonstrated risks.

Where appropriate, telehealth and other flexible models of care should be considered to reduce unnecessary barriers to specific parts of the process, such as preparation, integration, additional follow-ups, and care coordination.

Patient Safety, Honest Disclosure, and Non-Punitive Care

Patient safety also depends on patients being able to communicate openly and honestly with healthcare providers. SSDP urges FDA to promote a non-punitive, patient-centered approach to safety monitoring and clinical care. A person’s disclosure of prior or current psychedelic use outside of an FDA-regulated therapeutic setting should not, by itself, result in denial of care, stigmatization, unnecessary exclusion from treatment, or referral to law enforcement. People who experience adverse events following psychedelic use should be encouraged to seek medical attention and behavioral health care from knowledgeable clinicians with accurate information without fear of punishment.

This is not a request for FDA to determine the legal status of non-medical psychedelic use, but rather reflects a serious patient safety concern. Fear of punitive consequences can discourage potential patients from seeking medical help or honestly disclosing medically relevant information, which can leave healthcare providers without information needed to assess adverse events, identify drug interactions, understand patient histories, and provide appropriate care. A safety framework should encourage honest communication and help-seeking rather than create incentives for individuals to conceal relevant medical information.

Data Collection, Privacy, and Data Sovereignty

Finally, standardized, privacy-protective data collection should be encouraged so that providers and researchers can better understand treatment outcomes, adverse events, patient experiences, and disparities in access over time — not solely focus on acute drug effects.

Data collection should include long-term and real-world outcomes, including quality of life, durability of benefits, adverse events, reasons for discontinuing treatment, barriers to access, and differences in outcomes among populations historically underrepresented in clinical research. Where scientifically appropriate, responsibly collected real-world data can complement clinical-trial data and help identify outcomes, disparities, and safety signals that may not become apparent in controlled trials.

Data collection should also be designed to promote trust rather than surveillance. Standards should incorporate strong privacy protections, data minimization, meaningful informed consent, and protections against unnecessary collection or disclosure of information that could expose patients or other individuals to legal, professional, or social consequences. Data gathered for patient safety and scientific research should not become a tool for punishing people who seek care or honestly report their experiences.

FDA should also engage Indigenous communities and other populations with longstanding cultural relationships to psychedelic substances when considering whether and how data concerning those communities should be collected, interpreted, standardized, or shared. Such engagement should respect informed consent, privacy, culturally sensitive or sacred knowledge, and established principles of data sovereignty. Participation in research or consultation should not be understood as blanket consent for traditional or community-held knowledge to be collected, shared, or incorporated into standardized datasets. Where such information is relevant to scientific research, FDA should encourage practices that preserve the cultural context necessary for accurate interpretation while respecting appropriate limits on its use and disclosure.

Conclusion

Drug policy should reduce harm rather than compound it. As psychedelic medicine develops, FDA has an opportunity to build a framework that protects patients without creating unnecessary barriers to care, recognizes cultural context without attempting to regulate practices outside the Agency’s remit, encourages honest disclosure and help-seeking without fear of punitive responses, protects patient privacy, and produces better evidence about patient experiences and outcomes.

The development of a medical model should expand options for people who need care without creating new forms of stigma, exclusion, or inequity. Regardless of how psychedelic-assisted therapies are ultimately regulated or delivered, SSDP urges FDA to advance a framework that prioritizes patient safety, dignity, informed choice, and meaningful access and that does not leave behind the people and communities who may need these therapies most.

Thank you for your consideration.