S.Amdt. 2617

SA 2617. Mr. BARRASSO submitted an amendment intended to be proposed
to amendment SA 2360 proposed by Mr. Thune (for Mr. Graham) to the bill
H.R. 1, to provide for reconciliation pursuant to title II of H. Con.
Res. 14; which was ordered to lie on the table; as follows:

At the appropriate place in title VII, insert the
following:

SEC. __. 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

[[Page S4026]]

526(a)(2) of the Federal Food, Drug, and Cosmetic Act)''.
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