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).