The FDA held its first public hearing on the Commissioner's National Priority Voucher program on June 4. Three hours. White Oak campus, Building 31. Panelists from the Commissioner's office, CDER, CBER, and the Oncology Center of Excellence.
Industry liked what it saw. Johnson & Johnson praised the collaborative review process. Partner Therapeutics credited the program with compressing Bizengri's approval from ten months to six weeks. Merck advocated for structured scientific engagement.
Critics did not. Peter Lurie — former FDA associate commissioner, now president of the Center for Science in the Public Interest — urged the agency to wind down the pilot, citing political interference. Janet Krommes of Doctors for America warned that opaque selection criteria had "given life to rumors about political influence." Thomas Hwang of Harvard said the program risked undermining the agency's credibility. Lowell Schiller of USC called for formal rulemaking to restore legitimacy.
Patient advocates pushed for inclusion — porphyria, Huntington's, rare diseases — asking why their conditions didn't qualify.
The panel responded to no testimony directly.
And no one — not industry, not critics, not patient groups — mentioned antimicrobial resistance.
The Scorecard
Since the program launched in 2025, the CNPV has approved seven applications. Three oncology drugs. Two metabolic therapies, including semaglutide. A gene therapy for hereditary hearing loss. And Augmentin XR — a domestically manufactured version of amoxicillin-clavulanate, a drug first approved in 2002.
The review times are extraordinary. Hernexeos in 44 days. Foundayo in 50 — the fastest new molecular entity approval since 2002. Bizengri in six weeks. The program does what it promises: it compresses review timelines from ten months to under two.
But the one antibiotic in the portfolio is not a new weapon against resistance. It is a supply chain fix — a U.S.-manufactured version of an existing drug, approved because America imports too much of its generic antibiotic supply and the Strait of Hormuz keeps making that arrangement look fragile. A necessary approval. Not the same thing as a novel antimicrobial.
The Bill That Cannot Vote
Meanwhile, the PASTEUR Act sits in the Committee on Energy and Commerce.
First introduced in 2020. Reintroduced in 2021. Again in 2023. Again in February 2026, as H.R. 7352. Four introductions across four Congresses. Sixty-five bipartisan cosponsors. Two hundred and thirty-seven organizational endorsements. Zero committee markups. Zero floor votes.
The bill would create subscription-style federal contracts for novel antimicrobials — $75 million to $300 million per year per drug, paid for value rather than volume. Stewardship requirements built in. An access framework. A statutory declaration that drug-resistant infection is a national priority worth $6 billion over a decade.
It cannot get a vote.
The Loophole
And yet antibiotics do get funded in America. Through a door that was built for something else.
Shionogi's cefiderocol received $482 million through Project BioShield — a bioterrorism preparedness program created after the anthrax attacks. Locus Biosciences' CRISPR-engineered phage LBP-EC01 got $93 million from BARDA. Armata's AP-SA02 — the only phage therapy in Phase 3 worldwide — runs on $26.2 million from the Department of Defense. BiomX's BX011 got $40 million from the Defense Health Agency.
The common thread: every one of these programs frames antimicrobial resistance as a threat to national security. The warfighter needs antibiotics that work against battlefield wound infections. BARDA's threat list includes engineered pathogens resistant to available drugs. Project BioShield has appropriated procurement authority — no new legislation needed, no Congressional vote required.
This is the loophole. AMR gets funded when it is called biodefense. Not when it is called public health.
What a Loophole Cannot Do
BARDA procurement buys specific products against specific threats. It does not build a commercial market. It does not create stewardship requirements. It does not ensure that a drug funded for military use reaches a hospital in Lagos or Dhaka. It does not address the structural collapse of the antibiotic business — the 35 percent pipeline decline documented by the 2026 AMR Benchmark, the graveyard of companies that tried and failed.
The UK subscription model was designed to solve this. Permanent since May 2024. Tendered at £1.9 billion. Four value bands. Contracts were supposed to start April 1. As of today — sixty-six days past the deadline — no awards have been announced.
PASTEUR would solve most of it. It has never been voted on.
BioShield solves none of it. It was not built for this. It works only because drug-resistant bacteria happen to overlap with the biodefense threat matrix. If BARDA leadership changes priorities, if budgets shift, if the bioterror framing loses political weight, the loophole closes.
The Open Docket
The CNPV comment period runs through June 29. Twenty-four days for the Infectious Diseases Society of America, the American Society for Microbiology, CARB-X, the Pew Charitable Trusts, the AMR Industry Alliance, and every clinician who has watched a patient die of an untreatable infection to put their arguments into the federal record.
If yesterday's hearing is the only public testimony, the future of America's fastest review pathway will be shaped without a single voice from the field that needs accelerated review most. The critics will debate political interference. Industry will celebrate speed. Patient advocates will push for their diseases. And antimicrobial resistance — 4.95 million associated deaths per year, projected to reach 39 million by 2050 — will remain what it was at the hearing: unmentioned.
The hearing is over. The docket is open. The question is whether anyone shows up.