I 

116TH CONGRESS 

1ST SESSION H. R. 5444 

To amend the Biologics Price Competition and Innovation Act of 2009 to 

streamline the transition of certain products from approval as a drug 

to licensure as a biological product, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 17, 2019 

Ms. UNDERWOOD (for herself, Ms. SCHAKOWSKY, Mr. GUTHRIE, Mr. KELLY

of Pennsylvania, and Mr. LEVIN of Michigan) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Biologics Price Competition and Innovation 

Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological 

product, 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 ‘‘Lower Insulin Costs 

5 Now Act’’. 


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1 SEC. 2. STREAMLINING THE TRANSITION OF BIOLOGICAL 

2 PRODUCTS. 

3 Section 7002(e)(4) of the Biologics Price Competition 

4 and Innovation Act of 2009 (Public Law 111–148) is 

5 amended— 

6 (1) by striking ‘‘An approved application’’ and 

7 inserting the following: 

8 ‘‘(A) IN GENERAL.—An approved applica9 tion’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(B) TREATMENT OF CERTAIN APPLICA12 TIONS.— 

13 ‘‘(i) IN GENERAL.—With respect to an 

14 application for a biological product sub15 mitted under subsection (b) or (j) of sec16 tion 505 of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 355) that is filed 

18 not later than March 23, 2019, and is not 

19 approved as of March 23, 2020, the Sec20 retary shall continue to review such appli21 cation under such section 505, after March 

22 23, 2020. 

23 ‘‘(ii) EFFECT ON LISTED DRUGS.— 

24 Only for purposes of carrying out clause 

25 (i), with respect to any applicable listed 


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1 drug with respect to such application, the 

2 following shall apply: 

3 ‘‘(I) Any drug that is a biological 

4 product that has been deemed licensed 

5 under section 351 of the Public 

6 Health Service Act (42 U.S.C. 262) 

7 pursuant to subparagraph (A) and 

8 that is referenced in an application 

9 described in clause (i), shall continue 

10 to be identified as a listed drug on the 

11 list published pursuant to section 

12 505(j)(7) of the Federal Food, Drug, 

13 and Cosmetic Act, and the informa14 tion for such drug on such list shall 

15 not be revised after March 20, 2020, 

16 until— 

17 ‘‘(aa) such drug is removed 

18 from such list in accordance with 

19 subclause (III) or subparagraph 

20 (C) of such section 505(j)(7); or 

21 ‘‘(bb) this subparagraph no 

22 longer has force or effect. 

23 ‘‘(II) Any drug that is a biologi24 cal product that has been deemed li25 censed under section 351 of the PubVerDate Sep 11 2014 01:45 Dec 27, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5444.IH H5444

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1 lic Health Service Act (42 U.S.C. 

2 262) pursuant to subparagraph (A) 

3 and that is referenced in an applica4 tion described in clause (i) shall be 

5 subject only to requirements applica6 ble to biological products licensed 

7 under such section. 

8 ‘‘(III) Upon approval under sub9 section (c) or (j) of section 505 of the 

10 Federal Food, Drug, and Cosmetic 

11 Act of an application described in 

12 clause (i), the Secretary shall remove 

13 from the list published pursuant to 

14 section 505(j)(7) of the Federal Food, 

15 Drug, and Cosmetic Act any listed 

16 drug that is a biological product that 

17 has been deemed licensed under sec18 tion 351 of the Public Health Service 

19 Act pursuant to subparagraph (A) 

20 and that is referenced in such ap21 proved application, unless such listed 

22 drug is referenced in one or more ad23 ditional applications described in 

24 clause (i). 


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1 ‘‘(iii) DEEMED LICENSURE.—Upon 

2 approval of an application described in 

3 clause (i), such approved application shall 

4 be deemed to be a license for the biological 

5 product under section 351 of the Public 

6 Health Service Act. 

7 ‘‘(iv) RULE OF CONSTRUCTION.— 

8 ‘‘(I) APPLICATION OF CERTAIN

9 PROVISIONS.— 

10 ‘‘(aa) PATENT CERTIFI11 CATION OR STATEMENT.—An ap12 plication described in clause (i) 

13 shall contain a patent certifi14 cation or statement described in, 

15 as applicable, section 505(b)(2) 

16 of the Federal Food, Drug, and 

17 Cosmetic Act or clauses (vii) and 

18 (viii) of section 505(j)(2)(A) of 

19 such Act and, with respect to any 

20 listed drug referenced in such ap21 plication, comply with related re22 quirements concerning any timely 

23 filed patent information listed 

24 pursuant to section 505(j)(7). 


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1 ‘‘(bb) DATE OF AP2 PROVAL.—The earliest possible 

3 date on which any pending appli4 cation described in clause (i) may 

5 be approved shall be determined 

6 based on— 

7 ‘‘(AA) the last expira8 tion date of any applicable 

9 period of exclusivity that 

10 would prevent such approval 

11 and that is described in sec12 tion 505(c)(3)(E), 

13 505(j)(5)(B)(iv), 

14 505(j)(5)(F), 505A, 505E, 

15 or 527 of the Federal Food, 

16 Drug, and Cosmetic Act; 

17 and 

18 ‘‘(BB) if the application 

19 was submitted pursuant to 

20 section 505(b)(2) of the 

21 Federal Food, Drug, and 

22 Cosmetic Act and references 

23 any listed drug, the last ap24 plicable date determined 

25 under subparagraph (A), 


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1 (B), or (C) of section 

2 505(c)(3) of such Act, or, if 

3 the application was sub4 mitted under section 505(j) 

5 of such Act, the last applica6 ble date determined under 

7 clause (i), (ii), or (iii) of sec8 tion 505(j)(5)(B). 

9 ‘‘(II) EXCLUSIVITY.—Nothing in 

10 this subparagraph shall be construed 

11 to affect section 351(k)(7)(D) of the 

12 Public Health Service Act. 

13 ‘‘(v) LISTING.—The Secretary may 

14 continue to review an application after 

15 March 23, 2020, pursuant to clause (i), 

16 and continue to identify any applicable list17 ed drug pursuant to clause (ii) on the list 

18 published pursuant to section 505(j)(7) of 

19 the Federal Food, Drug, and Cosmetic 

20 Act, even if such review or listing may re21 veal the existence of such application and 

22 the identity of any listed drug for which 

23 the investigations described in section 

24 505(b)(1)(A) of the Federal Food, Drug, 

25 and Cosmetic Act are relied upon by the 


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1 applicant for approval of the pending ap2 plication. Nothing in this subparagraph 

3 shall be construed as authorizing the Sec4 retary to disclose any other information 

5 that is a trade secret or confidential infor6 mation described in section 552(b)(4) of 

7 title 5, United States Code. 

8 ‘‘(vi) SUNSET.—Beginning on October 

9 1, 2022, this subparagraph shall have no 

10 force or effect and any applications de11 scribed in clause (i) that have not been ap12 proved shall be deemed withdrawn.’’. 

Æ 


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