118 HR 5539 IH: Optimizing Research Progress Hope And New Cures Act U.S. House of Representatives 2023-09-18 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I118th CONGRESS1st SessionH. R. 5539IN THE HOUSE OF REPRESENTATIVESSeptember 18, 2023Mr. 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 concernedA BILLTo 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.