The Senate Is Asking the VA to Build a Psychedelics Office Before the FDA Even Approves Anything

WASHINGTON — Congress isn’t waiting for the FDA to give the green light on psychedelic medicine. On April 29, the Senate Veterans’ Affairs Committee held a hearing on a bipartisan bill that would require the Department of Veterans Affairs to create an entire bureaucratic infrastructure for psychedelic-assisted therapies — staffing, credentialing, clinical standards — before a single psychedelic drug clears the agency’s approval process.

The measure in question, S.4220, the Veterans Health Administration Novel Therapeutics Preparedness Act of 2026, was introduced in March by Senators Tim Sheehy (R-MT) and Ruben Gallego (D-AZ), an Iraq War veteran. It would establish an Office of Novel Therapeutics inside the VA with a mandate to develop national readiness plans and clinical standards for emerging treatments including psilocybin, ibogaine, and MDMA. The office would also be responsible for credentialing the VA workforce to administer those therapies.

The logic is straightforward, if ambitious: federal approval of at least one psychedelic-assisted therapy is now widely considered a matter of when, not if. The VA serves some nine million veterans annually, a population that bears a disproportionate burden of PTSD, depression, traumatic brain injury, and treatment-resistant conditions that conventional therapies have largely failed to address. By the time an FDA-approved psychedelic therapy reaches a VA formulary under the current system, veterans could wait years — while the treatments are already available, legally or not, abroad.

The Case for Building the Infrastructure Now

The bill’s co-sponsors made that urgency explicit at the hearing. Sen. Gallego, who has also co-sponsored the Innovative Therapies Centers for Excellence Act, pointed to a real and growing phenomenon: veterans traveling to clinics in Mexico, Jamaica, and elsewhere for ibogaine and psilocybin treatments that aren’t sanctioned domestically.

“I’m personally very anxious to get this going because a lot of veterans are now going to Mexico and other parts of the world and getting unregulated therapies, which can be hit or miss, can be dangerous,” Gallego said during the hearing.

That danger isn’t hypothetical. A recent patient death at Ambio Life Sciences’ facility in Tijuana — involving ibogaine, a potent plant-derived psychedelic sometimes used in opioid addiction treatment — illustrated the stakes. Ibogaine carries serious cardiac risks and has never been approved by the FDA, yet veterans are seeking it out because domestic options feel inadequate.

Under S.4220, the VA would be required to publish a national preparedness strategy within 180 days of enactment, establish a Veteran Advisory Committee to monitor patient safety outcomes, and — notably — ban “step therapy” protocols that currently force patients to try older, cheaper treatments before accessing newer ones. That last provision alone would be a significant departure from how the VA typically operates.

The VA’s Response: Cautiously Constructive

The department’s representative at the hearing, Dr. Mark A. Koeniger, the VA’s acting assistant under secretary for Health for Patient Care Services, was careful not to oppose the bill outright — but equally careful not to embrace it without conditions.

Koeniger told lawmakers that the VA already deploys “novel therapeutics” at 53 facilities, specifically ketamine and its nasal spray derivative esketamine (Spravato), which received FDA approval for treatment-resistant depression in 2019. He said the department is already “anticipating that some [psychedelic drugs] be approved by the FDA” and has formed an integrated project team to lay groundwork.

“We understand that these novel therapeutics have a potential benefit,” Koeniger said. “What we want to do is to make sure that those are rolled out in a very objective and scientific way, because we certainly don’t want to injure veterans.”

His caution centered on potential duplication — the risk that a new statutory office overlaps with or complicates existing VA initiatives. He offered to work with committee members to identify gaps before the bill advances.

It’s a familiar posture. The VA has a long institutional habit of moving deliberately on anything outside the established formulary. Whether that deliberateness looks like responsible stewardship or bureaucratic inertia tends to depend on whether you’re the administrator or the veteran.

Outside Voices: The VA Wasn’t Built for This

Advocates at the hearing were less charitable about the status quo.

Melissa Lavasani, founder of the Washington, DC-based Psychedelic Medicine Coalition, who attended the hearing, framed the issue in structural terms. “What came through in this hearing is that the VA is being asked to solve 21st-century health challenges with a system that wasn’t built for them,” she told Filter. She called the hearing evidence of “real bipartisan acknowledgment that we need to evaluate treatments that don’t fit neatly into existing frameworks.”

Written testimony from Dr. Lynette Averill, chief science officer for the Veterans Mental Health Leadership Coalition and the advocacy group Reason for Hope, made the procedural risk explicit: without system-level reforms enacted before FDA approval, “the VA risks repeating a familiar pattern: promising treatments are approved, but Veterans wait years.”

That pattern is documented. Even after esketamine’s 2019 FDA approval, VA access lagged significantly behind private-sector clinics for several years. For a veteran population with elevated rates of suicide — the VA has reported roughly 17 veteran suicides per day in recent years — years matter.

What Comes Next

S.4220 now moves to the full Senate Veterans’ Affairs Committee for further consideration. Its bipartisan framing gives it better odds than most psychedelics-adjacent legislation in the current Congress, though the broader political dynamics around drug scheduling remain volatile — especially as the DOJ’s recent rescheduling of cannabis to Schedule III continues to generate regulatory ripple effects at the DEA and IRS.

The bill doesn’t attempt to reschedule anything. It doesn’t authorize clinical trials or direct the FDA to do anything at all. What it does is ask the VA to stop waiting and start preparing — on the reasonable assumption that psychedelic medicine is coming whether the federal apparatus is ready or not.

Whether Congress agrees that readiness is worth mandating, rather than leaving to the agency’s discretion, will become clearer as the bill advances through committee. What’s not in dispute, after April 29’s hearing, is that at least some senators believe the cost of unpreparedness is one the country’s veterans have already paid too many times.

Ethan Vale covers federal drug policy for CannabisInquirer.com. Sources and additional documentation available on request.