ORPHAN Cures Act
Sponsored By: Representative Joyce (PA)
Introduced
Summary
Expands and clarifies the orphan drug exclusion in the Drug Price Negotiation Program. This bill would let products that treat one or more rare diseases qualify under the orphan drug framework and align the definition with the Federal Food, Drug, and Cosmetic Act. It also says the Secretary must not count any period when a drug had orphan designation when calculating elapsed time toward negotiation eligibility.
Show full summary
- Patients with rare diseases: More therapies that treat multiple rare conditions could be treated as orphan drugs for negotiation purposes, changing when they become subject to price talks.
- Drug developers: Manufacturers could claim orphan status for products covering multiple rare diseases and preserve orphan-designated time in timing calculations.
- Medicare program administrators: The Secretary would have to exclude orphan-designated periods from the timing rules that determine which drugs enter negotiation.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Orphan drug rules affect Medicare prices
If enacted, the bill would change how HHS treats orphan drugs under the Medicare drug price negotiation program. The Secretary would not count any time a medicine had orphan status when calculating how long since approval for negotiation. The bill would also let a drug be described as an orphan drug for one or more rare diseases, aligning the term to the FD&C Act. If passed, these changes could delay when Medicare starts negotiating some drug prices and could let more medicines keep orphan-related treatment.
Sponsors & CoSponsors
Sponsor
Joyce (PA)
PA • R
Cosponsors
Davis (NC)
NC • D
Sponsored 2/4/2025
Hern (OK)
OK • R
Sponsored 2/4/2025
Peters
CA • D
Sponsored 2/4/2025
Miller-Meeks
IA • R
Sponsored 2/4/2025
Keating
MA • D
Sponsored 2/4/2025
Hudson
NC • R
Sponsored 2/4/2025
Thanedar
MI • D
Sponsored 2/4/2025
Bilirakis
FL • R
Sponsored 2/4/2025
Gottheimer
NJ • D
Sponsored 2/4/2025
Smucker
PA • R
Sponsored 4/7/2025
Bynum
OR • D
Sponsored 4/7/2025
Kean
NJ • R
Sponsored 4/7/2025
Titus
NV • D
Sponsored 4/7/2025
Salinas
OR • D
Sponsored 5/20/2025
Dunn (FL)
FL • R
Sponsored 5/20/2025
Gray
CA • D
Sponsored 6/12/2025
Crenshaw
TX • R
Sponsored 6/12/2025
Bresnahan
PA • R
Sponsored 9/30/2025
Roll Call Votes
No roll call votes available for this bill.
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