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H.R. 946 · House bill · 119th Congress
This bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.
The Medicare Drug Price Negotiation Program requires the Centers for Medicare & 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.
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.
This Act may be cited as the “Optimizing Research Progress Hope And New Cures Act” or the “ORPHAN Cures Act”.
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)”.