[Congressional Record Volume 168, Number 133 (Saturday, August 6, 2022)]
[Senate]
[Pages S4341-S4342]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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).
                                 ______