[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5444 Introduced in House (IH)]
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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.
Be it enacted by the Senate and House of Representatives 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''.
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 application''; and
(2) by adding at the end the following:
``(B) Treatment of certain applications.--
``(i) In general.--With respect to an
application for a biological product submitted
under subsection (b) or (j) of section 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 Secretary shall continue to review
such application 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 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 information 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
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 be
subject only to requirements applicable
to biological products licensed under
such section.
``(III) Upon approval under
subsection (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 section 351
of the Public Health Service Act
pursuant to subparagraph (A) and that
is referenced in such approved
application, unless such listed drug is
referenced in one or more additional
applications described in clause (i).
``(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 certification
or statement.--An application
described in clause (i) shall
contain a patent certification
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 application,
comply with related
requirements concerning any
timely filed patent information
listed pursuant to section
505(j)(7).
``(bb) Date of approval.--
The earliest possible date on
which any pending application
described in clause (i) may be
approved shall be determined
based on--
``(AA) the last
expiration date of any
applicable period of
exclusivity that would
prevent such approval
and that is described
in section
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
applicable date
determined under
subparagraph (A), (B),
or (C) of section
505(c)(3) of such Act,
or, if the application
was submitted under
section 505(j) of such
Act, the last
applicable date
determined under clause
(i), (ii), or (iii) of
section 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 listed 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 reveal 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
applicant for approval of the pending
application. Nothing in this subparagraph shall
be construed as authorizing the Secretary to
disclose any other information that is a trade
secret or confidential information 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 described in clause
(i) that have not been approved shall be deemed
withdrawn.''.
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