Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program

(a) In general Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended— (1) in paragraph (1), in the matter preceding subparagraph (A), 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) striking 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).; (3) and inserting through (4); (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). Act); and (3) by adding at the end the following new paragraph: (4) Treatment of former orphan drugs In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A), paragraph (1)(A)(ii) or (1)(B)(ii) (as applicable) shall apply as if the reference to the date of such approval or the date of such licensure, respectively, were instead a reference to the first day after the date of such approval for which such drug is not a drug described in paragraph (3)(A) or the first day after the date of such licensure for which such biological product is not a biological product described in paragraph (3)(A), respectively.. (b) Application The amendments made by subsection (a) shall apply with respect to initial price applicability years (as defined in section 1191(b) of the Social Security Act (42 U.S.C. 1320f(b))) beginning on or after January 1, 2028.