# 119-hr-946: ORPHAN Cures Act

119-hr-946, ORPHAN Cures Act, is a 119th Congress bill sponsored by Rep. Joyce, John [R-PA-13] (R-PA); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-hr-946
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-946
- Congress: 119
- Title: ORPHAN Cures Act
- Status: introduced
- Introduced: 2025-02-04
- Sponsor: Rep. Joyce, John [R-PA-13] (R-PA)
- Cosponsors: 18
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## 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. - 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.

## Cosponsors (18)

- Rep. Davis, Donald G. [D-NC-1] (D-NC), 2025-02-04T00:00:00.000Z
- Rep. Hern, Kevin [R-OK-1] (R-OK), 2025-02-04T00:00:00.000Z
- Rep. Peters, Scott H. [D-CA-50] (D-CA), 2025-02-04T00:00:00.000Z
- Rep. Miller-Meeks, Mariannette [R-IA-1] (R-IA), 2025-02-04T00:00:00.000Z
- Rep. Keating, William R. [D-MA-9] (D-MA), 2025-02-04T00:00:00.000Z
- Rep. Hudson, Richard [R-NC-9] (R-NC), 2025-02-04T00:00:00.000Z
- Rep. Thanedar, Shri [D-MI-13] (D-MI), 2025-02-04T00:00:00.000Z
- Rep. Bilirakis, Gus M. [R-FL-12] (R-FL), 2025-02-04T00:00:00.000Z
- Rep. Gottheimer, Josh [D-NJ-5] (D-NJ), 2025-02-04T00:00:00.000Z
- Rep. Smucker, Lloyd [R-PA-11] (R-PA), 2025-04-07T00:00:00.000Z
- Rep. Bynum, Janelle S. [D-OR-5] (D-OR), 2025-04-07T00:00:00.000Z
- Rep. Kean, Thomas H. [R-NJ-7] (R-NJ), 2025-04-07T00:00:00.000Z
- Rep. Titus, Dina [D-NV-1] (D-NV), 2025-04-07T00:00:00.000Z
- Rep. Salinas, Andrea [D-OR-6] (D-OR), 2025-05-20T00:00:00.000Z
- Rep. Dunn, Neal P. [R-FL-2] (R-FL), 2025-05-20T00:00:00.000Z
- Rep. Gray, Adam [D-CA-13] (D-CA), 2025-06-12T00:00:00.000Z
- Rep. Crenshaw, Dan [R-TX-2] (R-TX), 2025-06-12T00:00:00.000Z
- Rep. Bresnahan, Robert P. [R-PA-8] (R-PA), 2025-09-30T00:00:00.000Z

## Provisions PRIA read

- Orphan drug rules affect Medicare prices: mixed, medium. 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 dru…

## Related bills

- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025
- 119-hr-9877: Health Equity and Accountability Act of 2026
- 119-hr-6130: ASAP Act
- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-5401: Pay Our Troops Act of 2026

## Sources
- [119-hr-946 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/946)

## Related
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [119-hr-9877: Health Equity and Accountability Act of 2026](https://policyrisk.com/legislation/119-hr-9877)
- [119-hr-6130: ASAP Act](https://policyrisk.com/legislation/119-hr-6130)
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-5401: Pay Our Troops Act of 2026](https://policyrisk.com/legislation/119-hr-5401)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-946 (as of 2026-04-21).