Section 1 Short title
This Act may be cited as the “Optimizing Research Progress Hope And New Cures Act” or the “ORPHAN Cures Act”.
Optimizing Research Progress Hope And New Cures Act
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.
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—
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).”
in paragraph (3)(A)—
by striking “only one rare disease or condition” and inserting “one or more rare diseases or conditions”; and
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)”.