Federal contracts would pay developers to keep infection medicines available

Federal health officials could offer contracts to developers of eligible infection medicines. Covered medicines act on bacteria, fungi, or substances they produce. Vaccines and drugs that work only at concentrations too toxic to reasonably study in people would not qualify. Medicines must address an unmet medical need and treat a CDC-listed urgent or serious threat, or another pathogen federal health officials select. Applications would need to meet a minimum score to win approval. Developers would have to submit initial applications no later than two years after the medicine’s approval or licensure.

The proposal would set aside $6 billion for medicine contracts and related programs. Payments would go to developers awarded medicine contracts. Annual contract payments would range from $75 million to $300 million, adjusted for inflation, before subtracting the medicine's net U.S. sales revenue. The money would be available for fiscal year 2026 until spent. Contracts would end 10 years after approval or sooner when officials determine an approved generic or similar biological version is being marketed.

Contracted developers would have to maintain supplies, report resistance trends, and follow manufacturing practices that control drug pollution. Developers would need to support reliable supply chains and submit a shortage plan within 30 days after an FDA shortage finding. Officials could stop payments for permanent U.S. market withdrawal or serious contract failures left uncorrected after notice and a chance to fix them. Commercial availability and production sufficient to meet U.S. patient needs would be required starting 30 days after the first payment and continuing through the contract.

Federal health officials would offer facility grants and an outpatient pilot to support careful antibiotic use. Facility grants would cover hospitals, skilled nursing facilities, and other health facilities. The outpatient pilot would cover doctors, hospital outpatient departments, urgent care centers, and clinics located with pharmacies or retail stores. Facility grants would also support participation in federal infection and antibiotic-use tracking. These grants and other careful-use efforts could use no more than 6.5% of the $6 billion. Officials would establish the facility grant program within one year of enactment.

The CDC would collect and publish information on infection medicine use and drug resistance. Tracking would cover antibiotic and antifungal use, resistance trends, and tests used to diagnose infections and guide treatment. The public reporting requirement would start two years after enactment and require updates at least annually.