119-S1862

Bill is currently in: Senate
Path to Law
House Senate President

119th CONGRESS

1st Session

S. 1862

1. Short title
2. Expanding and clarifying 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 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended—

(1) Treatment of former orphan drugs - 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).

(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)".