Wide range of parties ask FDA to be flexible, protect patients when regulating psychedelic drugs

Stakeholders are urging the US Food and Drug Administration (FDA) to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). The agency should be careful not to create unnecessary barriers to patient access, promote proper training and credentialing, and allow flexibility in updating labeling as additional knowledge becomes available, according to individuals and groups that commented via a public docket.

Earlier this summer, FDA held a hybrid meeting to gather stakeholder feedback on how it can help promote the development of psychedelic drugs and opened a public docket. The docket has received more than 600 comments so far from a wide range of parties, including drugmakers, researchers, healthcare systems, and public advocates. The meeting announcement came the same week as the agency published a final guidance on the issue, and top officials published an article stating they were open to innovative approaches to regulating the drugs. (RELATED: FDA to consider ‘innovative approaches’ to psychedelic drug development, Regulatory Focus 10 September 2026)

Otsuka

Otsuka asked FDA to take into consideration that psychedelic drugs encompass a broad category of drugs and vary greatly in terms of their mechanism of action, clinical effect, patient subjective effect, safety profile, administration setting, and administration requirements. With that in mind, the company asked the agency to ensure that it considers the drugs within a flexible real-world care model that accounts for training, access, data collection, and implementation.

"Otsuka recommends that training and credentialing expectations that FDA factors into the conditions for safe and effective use of psychedelic drugs be built on existing licensure and scope-of-practice rules, supplemented by product-specific requirements where warranted," said Otsuka. "Rather than a new profession-wide license or credential for psychedelic medicines as a whole, FDA should build in flexibility by clinical situation, patient experience, and safety profile—favoring national competency-based standards using existing healthcare professional licensure and scope-of-practice frameworks wherever appropriate—and granting states and professional societies flexibility to operationalize training and credentialing."

Otsuka addressed three issues that FDA asked for specific feedback on, including ensuring patient safety. The company said the agency should center patient protection using a risk-based approach and consider a risk-stratified approach that scales monitoring based on the patient experience and drug effects.

Otsuka also addressed FDA’s question on patient access. The company said several factors determine patients' access to the drugs, and the agency should allow flexibility to accommodate patients' and care-setting needs.

"Overly prescriptive approaches risk limiting healthcare system capacity and creating barriers to timely patient access," said Otsuka. "FDA should share its expertise and coordinate closely with other agencies—including VA, CMS, and HRSA—that will shape the broader access environment.

"FDA should also be open to coordination with other stakeholders, such as the American Medical Association, as applicable CPT codes help ensure appropriate provider reimbursement for end-to-end treatment and support fulfillment of [Risk Evaluation and Mitigation Strategies (REMS)]-related requirements," the company added.

Finally, Otsuka recommended that FDA allow flexibility in training and credentialing. The company said REMS for psychedelic drugs should be treated as an additive requirement.

"Rather than adopting a single training or delivery approach for the entire category, support standardized outcomes and safety expectations, while allowing medical and professional societies with established expertise to set training and certification guidelines for their members that are grounded in the clinical science of safe administration," said Otsuka. "Standardizing provider pathways—rather than outcomes—risks reducing provider supply, increasing costs, worsening geographic inequities, lengthening wait times, and slowing adoption in an area of high unmet need.

"Nationally recognized competencies, risk-based training requirements, use of existing healthcare licensing frameworks, outcome monitoring, and quality metrics offer a path that balances safety with access," the company added.

PORTAL

Researchers at the Program On Regulation, Therapeutics, And Law (PORTAL), based in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, also commented on the docket. The group also noted the need for professional and accrediting bodies to establish training and credentialing standards, but emphasized that they need to be independent of manufacturers and commercial treatment providers.

"Independent clinical experts and patients should help develop the core curriculum and assess whether trainees meet its requirements," according to the PORTAL comment. "These should publish their sources of funding, and conflict-of-interest policies.

"Anybody with a financial interest in selling a drug, training course, or treatment service should not control decisions about professional qualifications," the group added. "Manufacturers may need to provide product-specific safety information, but independent bodies should determine how that information is incorporated into broader clinical training."

Like Otsuka, PORTAL also emphasized the need to focus on patient safety. The group said patient education and consent materials need to be tested with the people who will use them and to ensure they are understandable. It also said that safety requirements should be supported by clear clinical guidance and coordinated by the entire care team, and that clinics should provide patients with the support they need to complete safety requirements and receive follow-up care.

Echoing other commenters, PORTAL said it is important to ensure patients who may benefit from the drugs have access to them. In particular, the group said FDA and its federal partners should work together to address drug prices and the cost of delivering care, and emphasized that coverage and payment decisions should be based on independent assessments of comparative clinical benefits and the full cost of treatment.

"Payors should work with clinicians to define and reimburse the services needed across the course of treatment, including follow-up and care coordination," said PORTAL. "They should assess whether payment rates allow clinics to meet staffing and monitoring requirements and whether patients can obtain these services without substantial out-of-pocket costs.

"Telehealth may help with appropriate screening, follow-up, and coordination, provided patients can obtain in-person assessment when needed; however, as we have argued in prior work, individual clinicians’ efforts to help patients manage costs need to be accompanied by new rules relating to how drugs are priced and covered," the group added.

Regarding patient access, PORTAL also said that safety programs should be designed so they don't become unnecessary barriers to competition. In particular, the group noted that manufacturers often use patents on REMS procedures to delay entry of generic drugs and said such patents for psychedelic drugs should not be listed in the Orange Book.

Finally, PORTAL emphasized the need to develop best practices for data collection and data standardization. The group said that FDA should require sponsors to timely complete post-market studies and ensure results are publicly reported. It also said follow-up studies should be used to capture what happens to patients after they leave their treatment settings.

Cleveland Clinic

The Cleveland Clinic also touched on training and credentialing, patient safety, access considerations, and best practices for data collection. The healthcare system said that the FDA should require evidence-based training for everyone involved in psychedelic-assisted care that is periodically updated as more information about the drug and care comes to light. It also said the training needs will vary by phase of care and should emphasize cross-specialty coordination.

"Credentialing should be tied to role, scope of practice, and setting," said Cleveland Clinic. "Prescribers should have training in the therapeutic area and in the specific drug’s risks, contraindications, and REMS requirements.

"Non-prescribers should receive role-specific training on monitoring, patient support, escalation, documentation, and boundaries," the healthcare system added. "FDA should avoid credentialing requirements that are so narrow that they limit access across specialties or settings, but should expect institutions to verify completion of training, supervision arrangements, and competency before individuals participate in psychedelic-assisted care."

Cleveland Clinic said that patient safety depends on preparation, education, and supportive monitoring. The healthcare system said that patients should be educated that psychedelics may increase suggestibility and alter perceptions, making them highly suggestible. It said that this needs to be addressed during the informed consent process, which should also educate patients about the risks of psychological distress, challenging experiences, and other issues.

"FDA should use REMS-based controls and closed distribution practices to mitigate diversion risk," said Cleveland Clinic. "Psychedelic drug products should not be dispensed directly to patients for unsupervised use when the approved model requires supervised administration.

"Instead, product distribution should flow to certified pharmacies or certified healthcare settings, with appropriate storage, inventory control, documentation, and chain-of-custody practices, such as secure medication dispensing systems," the healthcare system added.

Echoing other commenters, Cleveland Clinic also encouraged FDA to engage with other federal partners to address drug access issues and said payors should start preparing for potential coverage models now. The healthcare system also said the agency should ensure it is flexible enough to avoid unnecessary constraints that could limit patient access.

Like other stakeholders, Cleveland Clinic emphasized that telehealth may play a key role in follow-up and care coordination, especially for rural and underserved communities, to help address patient access.

"Drug administration and acute monitoring should occur in person, but preparatory visits, education, certain screening activities, follow-up visits, and coordination with community providers may be appropriate for telehealth when clinically suitable and consistent with applicable law," said the healthcare system.

Finally, Cleveland Clinic said it supported federal or federally coordinated data repositories to help collect real-world data on psychedelic drugs, as well as the use of electronic health records, pharmacy data, REMS data, and more. It also supported the use of common data elements across data sources for drugs, dosages, indications, settings, and patient characteristics.

"Common data elements should include the specific drug, dosage, route of administration, indication, number and timing of administrations, care setting, staffing model, patient demographics, comorbidities, baseline severity, concomitant medications, and follow-up outcomes," said Cleveland Clinic. "Particular attention should be paid to differences by drug, indication, age, comorbidity, and historically underrepresented populations, because clinical trial populations may not fully reflect real-world patients."

Public Citizen

The public advocacy group, Public Citizen, wrote that it was concerned about three psychedelic drugs that are being evaluated under the Commissioner’s National Priority Voucher (CNPV) pilot program. The group cited a 2017 study finding that new drugs evaluated under accelerated pathways have been associated with an increased need for safety label changes after approval, and raised concerns that the extremely fast review of high-risk products may not provide sufficient safety data until after approval.

"For a class of medications that remains relatively new to the FDA, there should be careful and complete review of the benefits and harms of each therapeutic, which is impossible to accomplish within a one- to two-month review time frame," said Public Citizen.

Public Citizen said it supports the use of a REMS program with elements to assure safe use (ETASU) for any approved psychedelic drugs because they have serious dissociation and hallucinogenic potential, as well as cardiovascular side effect risks. The group pointed to the REMS program used for Johnson and Johnson's Spravato (esketamine) to treat treatment-resistant depression (TRD) or major depressive disorder (MDD) as an example.

More specifically, Public Citizen said FDA should require that psychedelic drugs be prescribed only by licensed psychiatrists who have REMS training and certification. The group also said the agency should require that patients be evaluated beforehand for potential contraindications, that the drugs be administered only in REMS-certified outpatient or inpatient health care settings, and that patients be registered in a registry to monitor clinical outcomes and adverse effects.

"We recognize that needed safety measures to protect patients can also make a medication harder to access and increase administrative work for prescribers," said Public Citizen. "Nonetheless, if or when the FDA approves psychedelic therapeutics, the agency must prioritize ensuring patient safety.

"Part of the approval of any new psychedelic therapeutic should be requirements for strong patient protection measures that can be promptly updated when new evidence develops," the group added.