ORPHAN Cures Act

Bill: 119-hr-946
Sponsor: full_name: Rep. Joyce, John [R-PA-13]
Introduced: 2025-02-04
Policy area: Health
Subjects: Health care costs and insurance

Medicare

Prescription drugs
Latest action: action_date: 2025-02-06
text: Sponsor introductory remarks on measure. (CR H535-536)

Summaries:
action_date: 2025-02-04
action_desc: Introduced in House
text: <p><strong>Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act</strong></p><p>This bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.</p><p>The Medicare Drug Price Negotiation Program requires the Centers for Medicare &amp; Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition.</p><p>The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.</p>

tv_txt: I 119th CONGRESS 1st Session H. R. 946 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.

1. Short title This Act may be cited as the Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act . 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) .