II 

118TH CONGRESS 

1ST SESSION S. 1120 

To improve the actions available to eligible product developers in the event 

of delays in receiving covered product for purposes of generic drug 

or biosimilar biological product development. 

IN THE SENATE OF THE UNITED STATES 

MARCH 30, 2023 

Ms. HASSAN (for herself and Mr. BRAUN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To improve the actions available to eligible product developers in the event of delays in receiving covered product 

for purposes of generic drug or biosimilar biological product development. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improved Access to 

5 Affordable Medications Act’’. 


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1 SEC. 2. AMENDMENTS TO ACTIONS FOR DELAYS OF GE2 NERIC DRUGS AND BIOSIMILAR BIOLOGICAL 

3 PRODUCTS. 

4 Section 610 of division N of the Further Consolidated 

5 Appropriations Act, 2020 (Public Law 116–94; 21 U.S.C. 

6 355–2) is amended— 

7 (1) in subsection (a)— 

8 (A) in paragraph (1)(C)— 

9 (i) by inserting ‘‘or contractual 

10 terms’’ after ‘‘additional conditions’’; and 

11 (ii) by inserting ‘‘by the license hold12 er’’ after ‘‘covered product’’; 

13 (B) in paragraph (2)(A)(iii), by striking 

14 ‘‘including any device’’ and inserting ‘‘including 

15 any packaging, device, or accessory’’; 

16 (C) by redesignating paragraphs (3) 

17 through (10) as paragraphs (4) through (11), 

18 respectively; 

19 (D) by inserting after paragraph (3) the 

20 following: 

21 ‘‘(4) the term ‘designated delivery service’ 

22 means any delivery service provided by a trade or 

23 business that the Secretary determines— 

24 ‘‘(A) is available to the general public 

25 throughout the United States; 


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1 ‘‘(B) records electronically to its database, 

2 kept in the regular course of its business, or 

3 marks on the cover in which any item referred 

4 to in this section is to be delivered, the date on 

5 which such item was given to such trade or 

6 business for delivery; and 

7 ‘‘(C) provides overnight or 2-day delivery 

8 service throughout the United States;’’; 

9 (E) in paragraph (6), as so redesignated, 

10 by inserting ‘‘including the parent company of 

11 such holder’’ after ‘‘covered product’’; and 

12 (F) in paragraph (11), as so redesig13 nated— 

14 (i) in subparagraph (A), in the matter 

15 preceding clause (i), by inserting ‘‘, at any 

16 time,’’ after ‘‘conduct testing’’; and 

17 (ii) in subparagraph (B), by inserting 

18 ‘‘, at any time,’’ after ‘‘fulfill’’; 

19 (2) in subsection (b)(2)— 

20 (A) in subparagraph (A)(iii)— 

21 (i) in the matter preceding subclause 

22 (I), by striking ‘‘a written request to pur23 chase sufficient quantities of the covered 

24 product to the license holder, and such re25 quest—’’ and inserting ‘‘one or more writVerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120

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1 ten requests to purchase sufficient quan2 tities of the covered product to the license 

3 holder for the relevant stage of develop4 ment, and each such request—’’; and 

5 (ii) in subclause (II), by inserting ‘‘or 

6 by a designated delivery service’’ before the 

7 semicolon at the end; and 

8 (B) in subparagraph (B), by amending 

9 clause (ii) to read as follows: 

10 ‘‘(ii) AUTHORIZATION.—The Sec11 retary shall, by written notice, authorize 

12 the eligible product developer to obtain suf13 ficient quantities of an individual covered 

14 product subject to a REMS with ETASU 

15 for purposes of development and testing— 

16 ‘‘(I) in the case of development 

17 and testing that does not involve 

18 human clinical trials, not later than 

19 60 days after the date on which a re20 quest under clause (i) is received, if 

21 the eligible product developer has 

22 agreed to comply with any conditions 

23 the Secretary determines necessary; or 

24 ‘‘(II) in the case of development 

25 and testing that involves human clinVerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120

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1 ical trials, not later than 120 days 

2 after the date on which a request 

3 under clause (i) is received, if the eli4 gible product developer has— 

5 ‘‘(aa)(AA) submitted proto6 cols, informed consent docu7 ments, and informational mate8 rials for testing that include pro9 tections that provide safety pro10 tections comparable to those pro11 vided by the REMS for the cov12 ered product; or 

13 ‘‘(BB) otherwise satisfied 

14 the Secretary that such protec15 tions will be provided; and 

16 ‘‘(bb) met any other require17 ments the Secretary may estab18 lish.’’; and 

19 (3) by adding at the end the following: 

20 ‘‘(h) SAMPLES ACCESS POLICY.—Not later than 45 

21 days after the date of approval of a covered product, or, 

22 in the case of a covered product approved before the date 

23 of enactment of the Improved Access to Affordable Medi24 cations Act, not later than 45 days after such date of en25 actment, each license holder of a covered product shall 


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1 make available its policy on evaluating and responding to 

2 requests submitted under subsection (b)(2)(A). Such pol3 icy shall— 

4 ‘‘(1) be made public and readily available, such 

5 as by posting such policy on a publicly available 

6 website; and 

7 ‘‘(2) shall include— 

8 ‘‘(A) contact information for the license 

9 holder to facilitate communication about written 

10 requests described in subsection (b)(2)(A)(iii); 

11 ‘‘(B) procedures for making such requests; 

12 ‘‘(C) the address to which such requests 

13 should be sent; 

14 ‘‘(D) the official license holder for each 

15 marketed product; and 

16 ‘‘(E) the named corporate officer who is 

17 responsible for receiving such requests.’’. 

Æ 


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