S.Amdt. 5423

SA 5423. Mrs. BLACKBURN (for herself and Mr. Grassley) submitted an
amendment intended to be proposed to amendment SA 5194 proposed by Mr.
Schumer to the bill H.R. 5376, to provide for reconciliation pursuant
to title II of S. Con. Res. 14; which was ordered to lie on the table;
as follows:

Strike section 11002 and insert the following:

SEC. 11002. SPECIAL RULE TO DELAY SELECTION AND NEGOTIATION
OF BIOLOGICS FOR BIOSIMILAR MARKET ENTRY.

(a) Treatment of Biological Products Highly Likely to Be
Subject to Biosimilar Competition Under Drug Price
Negotiation Program.--
(1) In general.--Section 1191(c) of the Social Security
Act, as added by section 11001, is amended by adding the
following new paragraph:
``(7) Biological product highly likely to be subject to
biosimilar competition.--
``(A) In general.--The term `biological product highly
likely to be subject to biological competition' means a
selected drug that is a biological reference product licensed
under section 351(a) of the Public Health Service Act, for
which the Secretary has determined that there is a high
likelihood that a biosimilar biological product will be
licensed under section 351(k) of the Public Health Service
Act and marketed by the end of the second year after the
selected drug publication date of the selected drug.
``(B) Determination.--For purposes of subparagraph (A), the
Secretary shall determine that a selected drug is a
`biological product highly likely to be subject to biological
competition' if, with respect to a biosimilar biological
product for which the selected drug is the reference
product--
``(i)(I) a biosimilar biological product application under
section 351(k) of the Public Health Service Act has been
licensed by the Food and Drug Administration;
``(II) no more than 2 years have elapsed since such
licensure;
``(III) marketing of such biosimilar biological product has
not commenced; and
``(IV)(aa) there has been no public announcement of a
patent litigation settlement or other agreement under which
the biosimilar application sponsor has agreed not to market
the biosimilar biological product; or
``(bb) there has been a publicly announced patent
litigation settlement or other agreement that permits the
biosimilar application sponsor to market the biosimilar
biological product before February 1 of the year that is two
years after the selected drug publication date of the
selected drug; or
``(ii)(I) a biosimilar biological product application under
section 351(k) of the Public Health Service Act has been
accepted for filing under such section by the Food and Drug
Administration;
``(II) the Food and Drug Administration has not issued a
complete response letter with respect to such application;
``(III) the biosimilar application sponsor has not
withdrawn such application; and
``(IV)(aa) there has been no public announcement of a
patent litigation settlement or other agreement under which
the biosimilar application sponsor has agreed not to market
the biosimilar biological product; or
``(bb) there has been a publicly announced patent
litigation settlement or other agreement that permits the
biosimilar application sponsor to market the biosimilar
biological product before February 1 of the year that is two
years after the selected drug publication date of the
selected drug.
``(C) Timing.--The Secretary shall make and announce a
determination under subparagraph (A) within 1 week of the
selected drug publication date of the selected drug.
``(D) Reconsideration.--
``(i) In general.--The manufacturer of the selected drug or
the manufacturer of a biosimilar biological product for which
the selected drug is the reference product may submit to the
Secretary a petition for reconsideration of a determination
under subparagraph (A) within 1 week of such determination.
``(ii) Response by secretary.--The Secretary shall respond
in writing to a petition for reconsideration submitted under
clause (i) and, as appropriate, make and announce a different
determination under subparagraph (A) within 1 week of the end
of the period during which such a petition may be submitted
under such clause.
``(E) Treatment.--For purposes of sections 1194 and 1195, a
selected drug that is a biological product highly likely to
be subject to biological competition shall be treated as if
the initial price applicability year with respect to such
drug were the initial price applicability year that is 2
years after the initial price applicability year with respect
to such drug.
``(F) Clarification.--A selected drug that is a biological
product highly likely to be subject to biological competition
shall continue to be considered a selected drug under this
part with respect to the number of negotiation-eligible drugs
published on the list under section 1192(a) with respect to
the initial price applicability year with respect to such
drug.
``(G) Definitions.--In this paragraph:
``(i) Biosimilar; biological product.--The terms
`biosimilar' and `biological product' have the meaning given
those terms in section 351(i) of the Public Health Service
Act.
``(ii) Biosimilar application sponsor.--The term `bosimilar
application sponsor' means the person who submits an
application for licensure under section 351(k) of the Public
Health Service Act.
``(iii) Patent litigation settlement.--The term `patent
litigation settlement' means an agreement reached between a
patent owner and a biosimilar applicant to resolve a patent
litigation dispute in whole or in part, reached either before
or after court action begins.
``(H) Regulations.--The Secretary shall promulgate
regulations implementing this paragraph through notice and
comment rulemaking, with a final rule published not later
than the date that is 90 days before the selected drug
publication date with respect to initial price applicability
year 2026.''.
(2) Conforming amendments.--
(A) Section 1191 of the Social Security Act, as added by
section 11001, is amended--
(i) in subsection (b)--

(I) in paragraph (2), by inserting ``(or, in the case of a
biological product highly likely to be subject to biosimilar
competition (as defined in subsection (c)(7)), the year that
is 2 years after the first initial price applicability
year)'' after ``the first initial price applicability year'';
(II) in paragraph (3), by inserting ``(or, in the case of a
biological product highly likely to be subject to biosimilar
competition, the date that is 2 years after the first initial
price applicability year)'' before the period; and
(III) in paragraph (4)(A)--

(aa) in the matter preceding clause (i), by inserting ``,
subject to subsection (c)(7)(E)'' after ``an initial price
applicability year with respect to a selected drug''; and
(bb) in clause (ii), by inserting ``(or, in the case of a
biological product highly likely to be subject to biosimilar
competition (as defined in subsection (c)(7)), February 28 of
the year that is 2 years after the year of the selected drug
publication date)'' after ``the selected drug publication
date''; and
(ii) in subsection (d)--

(I) in paragraph (2), by inserting ``and by substituting `3
years' for `2 years' '' after ``such selected drug'';
(II) in paragraph (4), by inserting ``and by substituting
`3 years' for `2 years' '' after ``such selected drug''.

(B) The flush matter at the end of section 1192 of the
Social Security Act, as added by section 11001, is amended by
inserting ``, section 1191(c)(7)(E),'' after ``subsection
(c)(2)''.
(C) Section 1193(a) of the Social Security Act, as added by
section 11001, is amended--
(i) in the matter preceding paragraph (1), by inserting
``(or, in the case of a biological product highly likely to
be subject to biosimilar competition (as defined in section
1191(c)(7)), February 28 of the year that is 2 years after
the year of the selected drug publication date)'' after ``the
selected drug publication date''; and
(ii) in paragraph (1), in the matter preceding subparagraph
(A), by inserting ``and

[[Page S4342]]

subject to section 1191(c)(7)(E)'' after ``in accordance with
section 1194''.
(D) Section 1194 of the Social Security Act, as added by
section 11001, is amended--
(i) in subsection (a), in the matter preceding paragraph
(1), by inserting ``, and subject to section 1191(c)(7)(E),''
after ``For purposes of this part'';
(ii) in subsection (b)(2)--

(I) in subparagraph (A), by striking ``with respect to the
selected drug'' and inserting ``with respect to such initial
price applicability year''; and
(II) in subparagraph (B), by inserting ``with respect to
such initial price applicability year,'' after ``the selected
drug publication date,''.

(E) Section 1195 of the Social Security Act, as added by
section 11001, is amended--
(i) in subsection (a), in the matter preceding paragraph
(1), by striking ``With respect to an initial price
applicability year'' and inserting ``Subject to section
1191(c)(7)(E), with respect to an initial price applicability
year''; and
(ii) in subsection (b)(2), by inserting ``(or, in the case
of a biological product highly likely to be subject to
biosimilar competition (as defined in section 1191(c)(7)),
the date that is two years after the date of publication
under this section)'' after ``the date of publication under
this section''.
(F) Section 5000D(b) of the Internal Revenue Code of 1986,
as added by section 11003(a), is amended--
(i) in paragraph (1), by inserting ``(except in the case of
a biological product highly likely to be subject to
biosimilar competition (as defined in section 1191(c)(7) of
the Social Security Act))'' after ``initial price
applicability year 2026''; and
(ii) in paragraph (2), by inserting ``(except in the case
of a biological product highly likely to be subject to
biosimilar competition (as defined in section 1191(c)(7)) of
the Social Security Act))'' after ``initial price
applicability year 2026''.
(b) Reduction of Additional IRS Funding for Enforcement.--
Section 10301(a)(1)(A)(i) of this Act is amended by striking
subclause (II).
______