[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4302 Introduced in Senate (IS)]
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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.
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 ``Biologics Market Transparency Act of
2022''.
SEC. 2. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED
APPLICATIONS FOR BIOLOGICAL PRODUCTS.
(a) In General.--Section 506I of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356i) is amended--
(1) in subsection (a)--
(A) by striking ``The holder of an application
approved under subsection (c) or (j) of section 505''
and inserting ``The holder of an application approved
under subsection (c) or (j) of section 505 of this Act
or subsection (a) or (k) of section 351 of the Public
Health Service Act'';
(B) in paragraph (2), by inserting ``(or, in the
case of a biological product, the proper name)'' after
``established name''; and
(C) in paragraph (3), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''; and
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``The holder of an application approved under
subsection (c) or (j)'' and inserting ``The holder of
an application approved under subsection (c) or (j) of
section 505 of this Act or subsection (a) or (k) of
section 351 of the Public Health Service Act'';
(B) in paragraph (1), by inserting ``(or, in the
case of a biological product, the proper name)'' after
``established name''; and
(C) in paragraph (2), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''.
(b) Additional One-Time Report.--Subsection (c) of section 506I of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to
read as follows:
``(c) Additional One-Time Report.--Within 180 days of the date of
enactment of the Biologics Market Transparency Act of 2022, all holders
of applications approved under subsection (a) or (k) of section 351 of
the Public Health Service Act shall review the information in the list
published under section 351(k)(9)(A) and shall submit a written notice
to the Secretary--
``(1) stating that all of the application holder's
biological products in the list published under section
351(k)(9)(A) that are not listed as discontinued are available
for sale; or
``(2) including the information required pursuant to
subsection (a) or (b), as applicable, for each of the
application holder's biological products that are in the list
published under section 351(k)(9)(A) and not listed as
discontinued, but have been discontinued from sale or never
have been available for sale.''.
(c) Purple Book.--Section 506I of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356i) is amended--
(1) in subsection (d)--
(A) by striking ``or (c), the Secretary'' and
inserting the following: ``or (c)--
``(1) the Secretary'';
(B) by striking the period at the end and inserting
``; and''; and
(C) by adding at the end the following:
``(2) the Secretary may identify the application holder's
biological products as discontinued in the list published under
section 351(k)(9)(A) of the Public Health Service Act, except
that the Secretary shall remove from the list, in accordance
with section 351(k)(9)(B) of such Act, any biological product
for which the license has been revoked or suspended for reasons
of safety, purity, or potency.''; and
(2) in subsection (e)--
(A) by inserting after the first sentence the
following: ``The Secretary shall update the list
published under section 351(k)(9)(A) of the Public
Health Service Act based on information provided under
subsections (a), (b), and (c) by identifying as
discontinued biological products that are not available
for sale, except that any biological product for which
the license has been revoked or suspended for reasons
of safety, purity, or potency shall be removed from the
list in accordance with section 351(k)(9)(B) of the
Public Health Service Act.''; and
(B) in the last sentence--
(i) by striking ``updates to the list'' and
inserting ``updates to the lists published
under section 505(j)(7)(A) of this Act and
section 351(k)(9)(A) of the Public Health
Service Act''; and
(ii) by striking ``update the list'' and
inserting ``update such lists''.
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