S3131-118

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— in paragraph (1), by adding at the end the following new subparagraph: 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 taken 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). (C)Treatment of former orphan drugsIn 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 taken into account any period during which such drug or product was a drug described in paragraph (3)(A).; and