I 118th CONGRESS 1st Session H. R. 5539 IN THE HOUSE OF REPRESENTATIVES September 18, 2023 Mr. Joyce of Pennsylvania (for himself and Mr. Nickel ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 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.

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 1191(e) of the Social Security Act ( 42 U.S.C. 1320f(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 taken 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 .