II 

117TH CONGRESS 

2D SESSION S. 4302 

To amend the Federal Food, Drug, and Cosmetic Act to require prompt 

reports of marketing status by holders of approved applications for biological products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 25, 2022 

Mr. KAINE (for himself, Mr. MARSHALL, Ms. HASSAN, and Mr. CASSIDY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

require prompt reports of marketing status by holders 

of approved applications for biological products, and for 

other purposes. 

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 ‘‘Biologics Market 

5 Transparency Act of 2022’’. 


kjohnson on DSK79L0C42PROD with BILLS
2 

•S 4302 IS

1 SEC. 2. PROMPT REPORTS OF MARKETING STATUS BY 

2 HOLDERS OF APPROVED APPLICATIONS FOR 

3 BIOLOGICAL PRODUCTS. 

4 (a) IN GENERAL.—Section 506I of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 

6 (1) in subsection (a)— 

7 (A) by striking ‘‘The holder of an applica8 tion approved under subsection (c) or (j) of sec9 tion 505’’ and inserting ‘‘The holder of an ap10 plication approved under subsection (c) or (j) of 

11 section 505 of this Act or subsection (a) or (k) 

12 of section 351 of the Public Health Service 

13 Act’’; 

14 (B) in paragraph (2), by inserting ‘‘(or, in 

15 the case of a biological product, the proper 

16 name)’’ after ‘‘established name’’; and 

17 (C) in paragraph (3), by striking ‘‘or ab18 breviated application number’’ and inserting ‘‘, 

19 abbreviated application number, or biologics li20 cense application number’’; and 

21 (2) in subsection (b)— 

22 (A) in the matter preceding paragraph (1), 

23 by striking ‘‘The holder of an application ap24 proved under subsection (c) or (j)’’ and insert25 ing ‘‘The holder of an application approved 

26 under subsection (c) or (j) of section 505 of 


kjohnson on DSK79L0C42PROD with BILLS
3 

•S 4302 IS

1 this Act or subsection (a) or (k) of section 351 

2 of the Public Health Service Act’’; 

3 (B) in paragraph (1), by inserting ‘‘(or, in 

4 the case of a biological product, the proper 

5 name)’’ after ‘‘established name’’; and 

6 (C) in paragraph (2), by striking ‘‘or ab7 breviated application number’’ and inserting ‘‘, 

8 abbreviated application number, or biologics li9 cense application number’’. 

10 (b) ADDITIONAL ONE-TIME REPORT.—Subsection 

11 (c) of section 506I of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 356i) is amended to read as follows: 

13 ‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 

14 days of the date of enactment of the Biologics Market 

15 Transparency Act of 2022, all holders of applications ap16 proved under subsection (a) or (k) of section 351 of the 

17 Public Health Service Act shall review the information in 

18 the list published under section 351(k)(9)(A) and shall 

19 submit a written notice to the Secretary— 

20 ‘‘(1) stating that all of the application holder’s 

21 biological products in the list published under sec22 tion 351(k)(9)(A) that are not listed as discontinued 

23 are available for sale; or 

24 ‘‘(2) including the information required pursu25 ant to subsection (a) or (b), as applicable, for each 


kjohnson on DSK79L0C42PROD with BILLS
4 

•S 4302 IS

1 of the application holder’s biological products that 

2 are in the list published under section 351(k)(9)(A) 

3 and not listed as discontinued, but have been discon4 tinued from sale or never have been available for 

5 sale.’’. 

6 (c) PURPLE BOOK.—Section 506I of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amend8 ed— 

9 (1) in subsection (d)— 

10 (A) by striking ‘‘or (c), the Secretary’’ and 

11 inserting the following: ‘‘or (c)— 

12 ‘‘(1) the Secretary’’; 

13 (B) by striking the period at the end and 

14 inserting ‘‘; and’’; and 

15 (C) by adding at the end the following: 

16 ‘‘(2) the Secretary may identify the application 

17 holder’s biological products as discontinued in the 

18 list published under section 351(k)(9)(A) of the 

19 Public Health Service Act, except that the Secretary 

20 shall remove from the list, in accordance with sec21 tion 351(k)(9)(B) of such Act, any biological prod22 uct for which the license has been revoked or sus23 pended for reasons of safety, purity, or potency.’’; 

24 and 

25 (2) in subsection (e)— 


kjohnson on DSK79L0C42PROD with BILLS
5 

•S 4302 IS

1 (A) by inserting after the first sentence the 

2 following: ‘‘The Secretary shall update the list 

3 published under section 351(k)(9)(A) of the 

4 Public Health Service Act based on information 

5 provided under subsections (a), (b), and (c) by 

6 identifying as discontinued biological products 

7 that are not available for sale, except that any 

8 biological product for which the license has been 

9 revoked or suspended for reasons of safety, pu10 rity, or potency shall be removed from the list 

11 in accordance with section 351(k)(9)(B) of the 

12 Public Health Service Act.’’; and 

13 (B) in the last sentence— 

14 (i) by striking ‘‘updates to the list’’ 

15 and inserting ‘‘updates to the lists pub16 lished under section 505(j)(7)(A) of this 

17 Act and section 351(k)(9)(A) of the Public 

18 Health Service Act’’; and 

19 (ii) by striking ‘‘update the list’’ and 

20 inserting ‘‘update such lists’’. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS