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 prod-
ucts from approval as a drug to licensure as a biological 
product, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Lower Insulin Costs 
Now Act’’. 
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SEC. 2. STREAMLINING THE TRANSITION OF BIOLOGICAL 
PRODUCTS. 
Section 7002(e)(4) of the Biologics Price Competition 
and Innovation Act of 2009 (Public Law 111–148) is 
amended— 
(1) by striking ‘‘An approved application’’ and 
inserting the following: 
‘‘(A) IN GENERAL.—An approved applica-
tion’’; and 
(2) by adding at the end the following: 
‘‘(B) TREATMENT OF CERTAIN APPLICA-
TIONS.— 
‘‘(i) IN GENERAL.—With respect to an 
application for a biological product sub-
mitted under subsection (b) or (j) of sec-
tion 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) that is filed 
not later than March 23, 2019, and is not 
approved as of March 23, 2020, the Sec-
retary shall continue to review such appli-
cation under such section 505, after March 
23, 2020. 
‘‘(ii) EFFECT
ON
LISTED
DRUGS.— 
Only for purposes of carrying out clause 
(i), with respect to any applicable listed 
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drug with respect to such application, the 
following shall apply: 
‘‘(I) Any drug that is a biological 
product that has been deemed licensed 
under section 351 of the Public 
Health Service Act (42 U.S.C. 262) 
pursuant to subparagraph (A) and 
that is referenced in an application 
described in clause (i), shall continue 
to be identified as a listed drug on the 
list published pursuant to section 
505(j)(7) of the Federal Food, Drug, 
and Cosmetic Act, and the informa-
tion for such drug on such list shall 
not be revised after March 20, 2020, 
until— 
‘‘(aa) such drug is removed 
from such list in accordance with 
subclause (III) or subparagraph 
(C) of such section 505(j)(7); or 
‘‘(bb) this subparagraph no 
longer has force or effect. 
‘‘(II) Any drug that is a biologi-
cal product that has been deemed li-
censed under section 351 of the Pub-
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lic Health Service Act (42 U.S.C. 
262) pursuant to subparagraph (A) 
and that is referenced in an applica-
tion described in clause (i) shall be 
subject only to requirements applica-
ble to biological products licensed 
under such section. 
‘‘(III) Upon approval under sub-
section (c) or (j) of section 505 of the 
Federal Food, Drug, and Cosmetic 
Act of an application described in 
clause (i), the Secretary shall remove 
from the list published pursuant to 
section 505(j)(7) of the Federal Food, 
Drug, and Cosmetic Act any listed 
drug that is a biological product that 
has been deemed licensed under sec-
tion 351 of the Public Health Service 
Act pursuant to subparagraph (A) 
and that is referenced in such ap-
proved application, unless such listed 
drug is referenced in one or more ad-
ditional 
applications 
described 
in 
clause (i). 
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‘‘(iii) 
DEEMED
LICENSURE.—Upon 
approval of an application described in 
clause (i), such approved application shall 
be deemed to be a license for the biological 
product under section 351 of the Public 
Health Service Act. 
‘‘(iv) RULE OF CONSTRUCTION.— 
‘‘(I) APPLICATION
OF
CERTAIN 
PROVISIONS.— 
‘‘(aa) 
PATENT
CERTIFI-
CATION OR STATEMENT.—An ap-
plication described in clause (i) 
shall contain a patent certifi-
cation or statement described in, 
as applicable, section 505(b)(2) 
of the Federal Food, Drug, and 
Cosmetic Act or clauses (vii) and 
(viii) of section 505(j)(2)(A) of 
such Act and, with respect to any 
listed drug referenced in such ap-
plication, comply with related re-
quirements concerning any timely 
filed patent information listed 
pursuant to section 505(j)(7). 
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‘‘(bb) 
DATE
OF
AP-
PROVAL.—The earliest possible 
date on which any pending appli-
cation described in clause (i) may 
be approved shall be determined 
based on— 
‘‘(AA) the last expira-
tion date of any applicable 
period of exclusivity that 
would prevent such approval 
and that is described in sec-
tion 
505(c)(3)(E), 
505(j)(5)(B)(iv), 
505(j)(5)(F), 505A, 505E, 
or 527 of the Federal Food, 
Drug, and Cosmetic Act; 
and 
‘‘(BB) if the application 
was submitted pursuant to 
section 505(b)(2) of the 
Federal Food, Drug, and 
Cosmetic Act and references 
any listed drug, the last ap-
plicable 
date 
determined 
under 
subparagraph 
(A), 
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(B), 
or 
(C) 
of 
section 
505(c)(3) of such Act, or, if 
the application was sub-
mitted under section 505(j) 
of such Act, the last applica-
ble date determined under 
clause (i), (ii), or (iii) of sec-
tion 505(j)(5)(B). 
‘‘(II) EXCLUSIVITY.—Nothing in 
this subparagraph shall be construed 
to affect section 351(k)(7)(D) of the 
Public Health Service Act. 
‘‘(v) LISTING.—The Secretary may 
continue to review an application after 
March 23, 2020, pursuant to clause (i), 
and continue to identify any applicable list-
ed drug pursuant to clause (ii) on the list 
published pursuant to section 505(j)(7) of 
the Federal Food, Drug, and Cosmetic 
Act, even if such review or listing may re-
veal the existence of such application and 
the identity of any listed drug for which 
the investigations described in section 
505(b)(1)(A) of the Federal Food, Drug, 
and Cosmetic Act are relied upon by the 
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applicant for approval of the pending ap-
plication. Nothing in this subparagraph 
shall be construed as authorizing the Sec-
retary to disclose any other information 
that is a trade secret or confidential infor-
mation described in section 552(b)(4) of 
title 5, United States Code. 
‘‘(vi) SUNSET.—Beginning on October 
1, 2022, this subparagraph shall have no 
force or effect and any applications de-
scribed in clause (i) that have not been ap-
proved shall be deemed withdrawn.’’. 
Æ 
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