S.Amdt. 2843

SA 2843. Mr. CARDIN submitted an amendment intended to be proposed by
him to the bill S. 4638, to authorize appropriations for fiscal year
2025 for military activities of the Department of Defense, for military
construction, and for defense activities of the Department of Energy,
to prescribe military personnel strengths for such fiscal year, and for
other purposes; which was ordered to lie on the table; as follows:

[[Page S5068]]

At the end of subtitle H of title X, insert the following:

SEC. 1095. DRUG SHORTAGES PREVENTION AND QUALITY IMPROVEMENT.

(a) Short Title.--This section may be cited as the ``Drug
Shortages Prevention and Quality Improvement Act''.
(b) Lengthen Expiration Dates to Mitigate Critical Drug
Shortages.--
(1) In general.--The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 506C-1 (21 U.S.C. 356c-
1) the following:

``SEC. 506C-2. 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
of 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) Notification.--
``(1) In general.--The Secretary may issue an order
requiring the manufacturer of any 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) Unavailable or insufficient data and information.--If
the data and information required pursuant to an order issued
under paragraph (1) are not available or are insufficient,
the Secretary may require the manufacturer of the drug to--
``(A) conduct studies adequate to provide the data and
information in accordance with section 211.166 of title 21,
Code of Federal Regulations (or any successor regulations);
and
``(B) submit to the Secretary the results, data, and
information generated by such studies when available.
``(c) Labeling.--The Secretary may issue an order requiring
the manufacturer of a life-saving drug to, by a specified
date, make any labeling change regarding the expiration date
that the Secretary determines to be appropriate based on the
data and information required to be submitted under this
section in accordance with labeling requirements under
subparts F and G of part 211 of title 21, Code of Federal
Regulations (or any successor regulations) or any other data
and information available to the Secretary.
``(d) 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.
``(e) Definition.--In this section, the term `life-saving
drug' means a drug described in section 506C(a).''.
(2) Civil monetary penalty.--Section 303(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by
adding at the end the following:
``(9)(A) If a manufacturer fails to submit data and
information as required under section 506C-2(b)(1), fails to
conduct or submit the results, data, and information
generated by studies as required under section 506C-2(b)(3),
or fails to make a labeling change as required under section
506C-2(c), such manufacturer shall be liable to the United
States for a civil penalty in an amount not to exceed $10,000
for each such violation.
``(B) If a violation described in subparagraph (A) is not
corrected within the 30-day period following notification by
the Secretary of a violation described in subparagraph (A),
the manufacturer shall, in addition to any penalty under
subparagraph (A), be subject to a civil monetary penalty of
not more than $10,000 for each day of the violation after
such period until the violation is corrected.''.
(c) Reporting on Increases in Demand for a Drug.--
(1) In general.--Section 506C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356c) is amended--
(A) in the section heading, by inserting ``or increase in
demand for'' after ``production of'';
(B) in subsection (a), in the matter following paragraph
(2), by striking ``drug, and the reasons for such
discontinuance or interruption'' and inserting ``drug, or
increase in the demand for such drug that is likely to lead
to a shortage of the drug, and the reasons for such
discontinuance, interruption, or increase in demand'';
(C) in subsection (b)--
(i) in paragraph (1), by striking ``; or'' and inserting a
semicolon;
(ii) by redesignating paragraph (2) as paragraph (3);
(iii) by inserting after paragraph (1) the following:
``(2) in the case of an increase in the demand for a drug,
not later than 30 days after the manufacture has knowledge of
such increase; or''; and
(iv) in paragraph (3), as so redesignated, by striking
``paragraph (1)'' and inserting ``paragraph (1) or (2)''; and
(D) in subsection (c), by inserting ``, or increase in
demand for,'' after ``the manufacture of''.
(2) Prohibited act.--
(A) In general.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end
the following:
``(jjj) The failure to notify the Secretary as required
under section 506C(a).''.
(B) Enforcement.--Section 303 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(c)) is amended--
(i) in paragraph (c), by adding before the period at the
end the following: ``; or (7) for having violated section
301(jjj) if such person acted in good faith and had a
reasonable basis for not notifying as required under section
506C''; and
(ii) by adding at the end the following:
``(h) Notwithstanding subsection (a), any manufacturer who
violates section 301(jjj) shall be subject to a civil penalty
in an amount not to exceed $50,000 per violation.''.
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