Psychedelics in D.C., FDA’s Framework, and New Zealand’s MDMA Prescribers

So first, let's look at these three federal meetings that took place last week in Washington, D.C., the U.S. Capitol.

The first many of you will have heard about.

It was an FDA, a Food and Drug Administration, public hearing that was hotly anticipated.

It was on the topic of psychedelics and their potential use in medicine.

And it took place on Monday last week at the agency's White Oak campus, just outside of Washington, D.C., in Maryland.

Here's what FDA's Deputy Center Director for Substance Use and Behavioral Health, Marta Sokolowska, had to say in opening the meeting.

Today's hearing is part of a whole of government effort to better understand the opportunities, challenges, and public health considerations associated with this evolving area of psychedelic drug treatment.

Most importantly, we are here today to listen.

There were around 300 people attending in person.

The vast majority of them were sort of psychedelics insiders.

I recognized most of them, whether they're advocates, researchers, entrepreneurs, or otherwise.

So there was a generally jubilant mood among those attendees.

You know, lots of clapping and applause after speakers' comments, even when asked not to.

There was a federal listening panel with FDA representatives as well as representatives from other agencies and institutes like the National Institute on Drug Abuse, SAMHSA, the Veteran Affairs Administration, and ARPA-H.

So usually that listening panel in these types of hearings, which are called Part 15 hearings, would be asking questions of speakers or discussing the topics, but this time they truly just listened with no questions or comments at all.

I think part of that was because there was such a long... almost laundry list of speakers and comments to get through with around 80 people speaking on the day.

And the FDA did say that they received more than 200 requests to speak.

So they had randomly chosen a subset of those requests.

So each speaker had just two minutes to rattle through their comments.

So given that format, a long list of speakers and very brief comments, it's perhaps not surprising that there wasn't all too much time for any discussion or comments from the federal panelists.

So in that sense, this was nothing like an advisory committee where the FDA convenes to discuss one particular drug product.

It was definitely much more of a sort of listening session.

We won't get into the topics discussed in any real detail here because you can head to our website to read an article that we wrote about the day's proceedings but generally a lot of comments focused on encouraging the agency not to treat psychedelics as a standalone drug therapy instead recognizing that it's often delivered in a broader package of care.

But there is a tension between that broader model and access, with some speakers saying something almost the opposite and encouraging the FDA and other federal partners to sort of approve the drug and let the practice of medicine and practitioners decide how it is delivered.

But that brings up the question of reimbursement, with any label for the drug potentially informing what gets paid for and at what level.