A psychedelic medicine could win FDA approval and still be out of reach for the people who need it. That was the practical concern running through a RealClearHealth salon dinner I hosted in Washington on October 13.
Around the table were mental health clinicians, veterans and patient advocates, researchers, policy experts, journalists, and people with firsthand experience of mental health challenges and psychedelic treatment. The group crossed ideological and professional lines, yet the discussion repeatedly returned to the same problems: government regulation, patient safety, clinician staffing and insurance coverage.
There is a reason to tackle those problems now. Millions of Americans live with depression or post-traumatic stress disorder that hasn't responded adequately to existing treatments. Juliana Mercer, a Marine Corps veteran and executive director of Healing Breakthrough, shared her experience with PTSD and psychedelic treatment. Dr. Steve Levine, a psychiatrist and chief patient officer at Compass Pathways, discussed research into the company's psilocybin candidate for treatment-resistant depression, currently in late-stage clinical trials.
In April, President Trump signed an executive order directing agencies to accelerate research and review of psychedelic treatments for serious mental illness. The Food and Drug Administration has since prioritized several investigational treatments and, in July, issued final guidance for psychedelic drug trials. The agency is still reviewing evidence that each proposed medicine is safe and effective, including data on adverse events and longer-term results. Public enthusiasm cannot be allowed to lower that standard.
But an approval would set off another series of government decisions. Psilocybin remains a Schedule I controlled substance. The Drug Enforcement Administration would need to take rescheduling action to permit an approved medicine's medical use. State restrictions could create further complications. The FDA and DEA should coordinate in advance so patients do not spend additional months waiting on paperwork after the scientific review is complete.
Just as important is how care would be delivered in practice. The clinical model being studied for psychedelic medicines includes screening for medical and psychiatric risks, preparation, a supervised dosing session lasting six to eight hours, and continued follow-up. Clinical protocols address potential adverse reactions and establish clear responsibilities for patient care after they complete treatment. The public needs to understand that the psilocybin model being studied involves supervised dosing in a clinic. FDA approval of a specific medicine would not legalize or decriminalize psychedelics more broadly.
The workforce is another consideration. Mental health professionals are already in short supply. Dr. Levine emphasized team-based care, with clinicians sharing responsibilities according to their training and licenses. A supervised session should not require multiple psychiatrists when other qualified professionals can handle parts of the work. Professional organizations and regulators need to settle training and staffing standards that protect patients and can function in real-world practice.
The VA and military health systems have special work to do. Physicians who serve veterans and service members need preparation before an approved treatment becomes an option. The VA has launched numerous studies involving psychedelic medicines and agreed to coordinate with HHS on research and readiness. Turning that work into care across hospitals and clinics will require trained staff, suitable facilities and a plan for ongoing treatment.
Coverage may prove just as consequential. CMS and private insurers will have to consider payment for the medicine, the hours of supervision, and the care before and afterward. They also need ways to account for improvements in quality of life, daily functioning and longer-term health.
Depression and other serious mental illnesses already carry substantial costs for healthcare systems and employers through repeated care, disability and lost productivity. Patients who begin recovering from mental illness may initially seek more routine medical care as they catch up on appointments they had neglected. As their health improves, overall healthcare use often falls, including fewer emergency visits and hospitalizations. Payers should consider that longer-term picture when weighing coverage.
The FDA must make its judgment based on evidence. In the meantime, the DEA, the VA, military healthcare leaders, CMS, private insurers and medical professionals should be preparing for the possibility of approval. Patients who have spent years looking for relief should not have to wait longer because the rest of Washington failed to do its homework.
