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To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.
Summary
This bill modifies the Drug Price Negotiation Program under Medicare by expanding protections for orphan drugs—medications developed to treat rare diseases. It clarifies that when calculating whether a drug is eligible for the federal price negotiation program, the time period during which the drug held orphan drug designation does not count toward the elapsed time calculation, effectively extending the time before such drugs become subject to negotiation. The bill also expands the definition of orphan drugs to include medications that treat multiple rare diseases, not just a single rare disease or condition. These changes would provide orphan drug manufacturers with an extended period of protection from the Medicare price negotiation program, which was established to bring down costs of high-priced drugs covered by Medicare.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Joyce, John [R-PA-13] (R-PA)
18 cosponsors
- Rep. Bilirakis, Gus M. [R-FL-12] (R-FL)
- Rep. Bresnahan, Robert P. [R-PA-8] (R-PA)
- Rep. Bynum, Janelle [D-OR-5] (D-OR)
- Rep. Crenshaw, Dan [R-TX-2] (R-TX)
- Rep. Davis, Donald G. [D-NC-1] (D-NC)
- Rep. Dunn, Neal P. [R-FL-2] (R-FL)
- Rep. Gottheimer, Josh [D-NJ-5] (D-NJ)
- Rep. Gray, Adam [D-CA-13] (D-CA)
- Rep. Hern, Kevin [R-OK-1] (R-OK)
- Rep. Hudson, Richard [R-NC-9] (R-NC)
- Rep. Kean, Thomas H. [R-NJ-7] (R-NJ)
- Rep. Keating, William R. [D-MA-9] (D-MA)
- Rep. Miller-Meeks, Mariannette [R-IA-1] (R-IA)
- Rep. Peters, Scott H. [D-CA-50] (D-CA)
- Rep. Salinas, Andrea [D-OR-6] (D-OR)
- Rep. Smucker, Lloyd [R-PA-11] (R-PA)
- Rep. Thanedar, Shri [D-MI-13] (D-MI)
- Rep. Titus, Dina [D-NV-1] (D-NV)
Money behind the sponsor
Top reported contributors to John Joyce’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- NULL $43,900
- JWF INDUSTRIES $13,570
- SMITH TRANSPORT, INC $13,200
- NESL $13,200
- MARTIN'S FAMOUS PASTRY SHOPPE, INC $12,400
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for John Joyce → · Outside spending →
Actions (3)
- Feb 6, 2025 Sponsor introductory remarks on measure. (CR H535-536)
- Feb 4, 2025 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. · house
- Feb 4, 2025 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
IN THE HOUSE OF REPRESENTATIVES
February 4, 2025
Mr. Joyce of Pennsylvania (for himself, Mr. Davis of North Carolina, Mr. Hern of Oklahoma, Mr. Peters, Mrs. Miller-Meeks, Mr. Keating, Mr. Hudson, Mr. Thanedar, Mr. Bilirakis, and Mr. Gottheimer) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Optimizing Research Progress Hope And New Cures Act” or the “ORPHAN Cures Act”.
SEC. 2. EXPANDING AND CLARIFYING THE EXCLUSION FOR ORPHAN DRUGS UNDER THE DRUG PRICE NEGOTIATION PROGRAM.
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f-1(e)) is amended—
(1) in paragraph (1), by adding at the end the following new subparagraph:
“(C) Treatment of former orphan drugs.—In calculating the amount of time that has elapsed with respect to the approval of a drug or licensure of a biological product under subparagraph (A)(ii) and subparagraph (B)(ii), respectively, the Secretary shall not take into account any period during which such drug or product was a drug described in paragraph (3)(A).”; and
(2) in paragraph (3)(A)—
(A) by striking “only one rare disease or condition” and inserting “one or more rare diseases or conditions”; and
(B) by striking “such disease or condition” and inserting “one or more rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act)”. <all>
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