Ten VA Sites, REMS and Ibogaine’s “Uphill Battle”: Feds Weigh In on Psychedelic Access

At the Psychedelic Healthcare Forum, which took place in New York City last Thursday and was co-hosted by Psychedelic Alpha, a panel of federal officials participated in a discussion moderated by POLITICO Deputy Health Care Editor Erin Schumaker.

Here, we share some of the key takeaways from that session, which featured the following:

• Valentina Mantua, Associate Director for Regulatory Science, U.S. Food and Drug Administration
• Andrew Gradison, Senior Advisor, U.S. Department of Veterans Affairs
• Al Bugazia, Deputy Director of Proactive Health, ARPA-H

VA May Struggle to Treat 1,000 Veterans with Psychedelics in Year One

Andrew Gradison is a Senior Advisor to the Veterans Health Administration, which sits within the VA, where he is deeply involved in the system’s psychedelics-related capacity building.

During the session, he emphasised that psychedelic therapies align with VA Secretary Doug Collins’ priorities, which apparently include “restoring the VA to a culture of innovation and bringing best-in-class treatments to our veterans as soon as they become available.”

A recurrent theme throughout the Psychedelic Healthcare Forum was that the availability of FDA-approved psychedelic therapies is one thing, but meaningful access is another. On that front, Schumaker pushed Gradison on the anticipated numbers of veterans who might have access to psychedelics.

VA covers 9 million veterans, Gradison explained, with 6.4 million of those receiving healthcare from the agency on a regular basis. Of those, he added, around 2.1 million have either PTSD, major depressive disorder, or treatment-resistant depression. “So the need is immense,” he went on.

Three weeks before the forum, Gradison added, he and colleagues “presented a phased implementation plan to the secretary to identify sites that will be first out of the chute.” Those sites tend to have experience with psychedelics in clinical trials, he noted.

That plan has seen the VA choose ten sites for now, though Gradison would not name them. “We launched our community of practice just last Thursday”, he added. (We teased this announcement last month, and noted that it might be somewhat modest.)

“We are preparing to be able to deploy these medicines as soon as they become commercially available,” he went on, “and by our timeline, if the rosiest scenario were to occur and these drugs were to become available in January or February of next year, we would begin treating patients immediately.”

How many patients might be treated at those ten sites, Schumaker pressed.

“It’s going to be slower going than our veteran population would like”, Gradison acknowledged. “It’s going to be slower going than I would like because, as you all know, these are very labour-intensive, resource-intensive interventions, and it’s our priority to make sure that we approach this work with a safety-first mentality.”

The agency will collect real-world evidence through its limited provision of psychedelics, which Gradison says will enable it to “continue to learn what works for which patients and, to the extent we can learn it, why.”

“I think, to manage expectations, it’ll be a challenge in the first year to treat four digits’ worth of patients”, he said more concretely. “Demand will exceed our ability to supply these therapies,” he again acknowledged later in the session, “no doubt.”

Group therapy may be one way to boost supply, ...