[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3793 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 3793
To amend the Federal Food, Drug, and Cosmetic Act to require
manufacturers of life-saving drugs to submit data and information to
assess the stability of the drugs and determine their longest supported
expiration date, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 5, 2023
Ms. Slotkin introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require
manufacturers of life-saving drugs to submit data and information to
assess the stability of the drugs and determine their longest supported
expiration date, 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 ``Ensuring Access to Lifesaving Drugs
Act of 2023''.
SEC. 2. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.
(a) In General.--The Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) is amended by inserting after section 506L of such
Act (21 U.S.C. 356l) the following new section:
``SEC. 506M. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.
``(a) In General.--A manufacturer of a life-saving drug shall--
``(1) submit to the Secretary data and information as
required by subsection (b)(1);
``(2) conduct and submit the results, data, and information
generated by any studies required under subsection (b)(2); and
``(3) make any labeling change described in subsection (c)
by the date specified by the Secretary pursuant to such
subsection.
``(b) Data and Information.--
``(1) In general.--The Secretary may issue an order
requiring the manufacturer of a life-saving drug to submit, in
such manner as the Secretary may prescribe, data and
information from any stage of development of the drug that are
adequate to assess the stability of the drug to determine the
longest supported expiration date.
``(2) Lack of data and information.--If the data and
information required pursuant to an order issued under
paragraph (1) are not available or are insufficient, as
determined by the Secretary, the Secretary may issue an order
requiring the manufacturer of the drug--
``(A) to conduct studies, which may be a
continuation of ongoing studies, to provide data and
information adequate to assess the stability of the
drug and to determine the longest supported expiration
date; and
``(B) to submit such data and information to the
Secretary in such manner as the Secretary may prescribe
in the order.
``(c) Labeling.--The Secretary may issue an order requiring the
manufacturer of a life-saving drug, by a date determined by the
Secretary in consultation with the sponsor of the drug, to make any
labeling change regarding the expiration date or storage and handling
of the drug that the Secretary determines to be appropriate based on
the data and information required to be submitted under this section or
any other data and information available to the Secretary.
``(d) Definitions.--In this section:
``(1) Life-saving drug.--The term `life-saving drug' means
a drug, that is--
``(A)(i) a medical countermeasure; or
``(ii) on the drug shortage list under section 506E
or determined by the Secretary to be at risk of
shortage; and
``(B)(i) life-supporting;
``(ii) life-sustaining; or
``(iii) intended for use in the prevention or
treatment of a debilitating disease or condition in
humans or animals, including any such drug used in
emergency medical care or during surgery or any such
drug that is critical to the public health during a
public health emergency declared by the Secretary under
section 319 of the Public Health Service Act.
``(2) Medical countermeasure.--The term `medical
countermeasure' means a countermeasure as defined in section
565(a).
``(e) Confidentiality.--Nothing in this section shall be construed
as authorizing the Secretary to disclose any information that is a
trade secret or confidential information subject to section 552(b)(4)
of title 5, United States Code, or section 1905 of title 18, United
States Code.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 3503(a)(1)(A) of
division FF of Public Law 117-328, is amended by inserting at the end
the following new subsection:
``(jjj) The failure to comply with any order issued under section
506M.''.
(c) Penalties.--Subsection (b) of section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by inserting at the
end the following:
``(9) If a manufacturer of a life-saving drug fails to submit data
and information as required under section 506M(b)(1), fails to conduct
or submit the data and information generated by studies as required
under section 506M(b)(2), or fails to make a labeling change as
required under section 506M(c), such manufacturer shall be subject to a
civil penalty of not more than $10,000 for the first day on which the
violation occurs and not more than $10,000 for each subsequent day on
which the violation is not corrected.''.
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