Old Drugs, New Cures Act
Sponsored By: Representative Davis (NC)
Introduced
Summary
This bill would create a new priority research drug designation to encourage new uses for older medicines and change how those drugs are treated in Medicare and Medicaid rebate and pricing rules.
Show full summary
- Patients and beneficiaries: People covered by federal programs could see different access and price dynamics for repurposed drugs because designated products would be handled differently in program pricing and rebate calculations while the designation lasts.
- Manufacturers: Drug makers could request designation for products approved at least 10 years earlier that are being tested for a new indication that addresses an unmet need and affects a population where at least 33% of prior-year claims were paid by federal programs. The Secretary would set a request process within 90 days and must decide on requests within 60 days.
- Federal payers and program costs: Medicare and Medicaid rebate and pricing rules would exclude designated drugs from the statutory “line extension” and from the Medicaid best-price special rule, changing how rebates and price reporting apply during designation.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
New drug label may reduce Medicare/Medicaid rebates
This bill would create a “priority research drug” label for some older prescription drugs. The Secretary would set up the request process within 90 days of enactment and decide within 60 days of a valid request. To qualify, a drug must be at least 10 years old, be studied for a new use with no approved alternative, and target conditions where at least 33% of related claims are paid by Medicaid/CHIP, Medicare Part D low‑income subsidies, 340B sites, or VA care. While a drug has this label, it would be excluded from Medicaid and Medicare line‑extension rules and a Medicaid “best price” special rule. That could mean smaller rebates and higher net costs for those programs, and possibly higher costs for some patients.
Sponsors & CoSponsors
Sponsor
Davis (NC)
NC • D
Cosponsors
Pfluger
TX • R
Sponsored 4/1/2025
Roll Call Votes
No roll call votes available for this bill.
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